PROSPER: Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer

Sponsor
Pfizer (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02003924
Collaborator
Astellas Pharma Inc (Industry), Medivation LLC, a wholly owned subsidiary of Pfizer Inc. (Industry)
1,401
Enrollment
397
Locations
2
Arms
122
Anticipated Duration (Months)
3.5
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety and efficacy of enzalutamide in patients with non metastatic prostate cancer.

Study Design

Study Type:
Interventional
Actual Enrollment :
1401 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
PROSPER: A MULTINATIONAL, PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, EFFICACY AND SAFETY STUDY OF ENZALUTAMIDE IN PATIENTS WITH NONMETASTATIC CASTRATION-RESISTANT PROSTATE CANCER
Actual Study Start Date :
Oct 31, 2013
Actual Primary Completion Date :
Jun 28, 2017
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

ArmIntervention/Treatment
Sham Comparator: Placebo

Sugar pill manufactured to mimic enzalutamide 40 mg capsule

Drug: Placebo
Sugar pill to mimic enzalutamide

Experimental: Enzalutamide

160 mg by mouth once daily

Drug: Enzalutamide
160 mg by mouth once daily
Other Names:
  • MDV3100
  • Xtandi
  • Outcome Measures

    Primary Outcome Measures

    1. Metastasis Free Survival (MFS) [From randomization until radiographic progression at any time, or death within 112 days of treatment discontinuation, whichever occurred first (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)]

      MFS:time from randomization to first date of radiographic progression (RP) (by Blinded independent central radiology review [BICR]) at any time or death within 112 days of treatment discontinuation without evidence of RP.RP for bone disease:appearance of 1 or more metastatic lesions on bone scan.RP for soft tissue disease:per Response Evaluation Criteria in Solid Tumors,[RECIST 1.1])-at least a 20 percent (%) increase in the sum of diameters of target lesions,taking as reference the smallest sum on study (includes the baseline sum if smallest on study).Participants who did not have MFS event at the time of analysis data cut-off (28 June 2017) were censored at date of last assessment showing no objective evidence of RP prior to skeletal-related event or two or more consecutive missed tumor assessments. Participants who were randomized but later confirmed to have metastatic disease before randomization were censored on date of randomization. Analysis was based on Kaplan-Meier estimates.

    Secondary Outcome Measures

    1. Time to Prostate-Specific Antigen (PSA) Progression [From randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)]

      Time to PSA progression was defined as the time from randomization to the date of first PSA value demonstrating progression, which was subsequently confirmed. For participants with PSA decline at Week 17, PSA progression was defined according to Prostate Cancer Working Group 2 (PCWG2) guidelines as the date that a 25% or greater increase and an absolute increase of 2 nanograms per milliliter (ng/mL) above the nadir (or baseline for participants with no PSA decline by Week 17) was documented, which was confirmed by a second consecutive value obtained at least 3 weeks or later. Participants without confirmed PSA progression at the time of analysis were right censored at the date of last PSA assessment before the analysis data cut-off date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.

    2. Time to First Use of New Antineoplastic Therapy [From randomization until first use of new antineoplastic therapy(until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)]

      Time to first use of new antineoplastic therapy was defined as the time from randomization to first use of new antineoplastic for prostate cancer. Participants not starting treatment with a new antineoplastic therapy at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.

    3. Overall Survival [From randomization until death (up to a maximum of 68.8 months)]

      Overall survival (OS) was defined as the time (in months) from randomization to death from any cause. For participants who were alive at the time of the analysis data cutoff, OS time was censored at the last date the participant was known to be alive or analysis data cutoff date, whichever was earlier. Participants with no post baseline survival information were censored on the date of randomization. Analysis was based on Kaplan-Meier estimates.

    4. Time to Pain Progression [From randomization until onset of pain progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)]

      Pain was assessed using the score from the Brief Pain Inventory-Short Form (BPI-SF) question 3: "Please rate your pain by marking the box beside the number that best describes your pain at its worst in the last 24 hours." Time to this event was defined as the time from randomization to onset of pain progression, where pain progression was defined as a 2-point or more increase from baseline in the question 3 score. Participants without observed pain progression at the time of analysis were right censored at the date of last pain assessment for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.

    5. Time to First Use of Cytotoxic Chemotherapy [From randomization up to the first use of cytotoxic chemotherapy (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)]

      Time to first use of cytotoxic chemotherapy was defined as the time from randomization to the first use of cytotoxic chemotherapy for prostate cancer. Participants not starting treatment with a cytotoxic chemotherapy for prostate cancer at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.

    6. Chemotherapy-Free Disease Specific Survival [From randomization up to first use of cytotoxic chemotherapy for prostate cancer or death due to prostate cancer (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)]

      Chemotherapy-free disease-specific survival was defined as the time from randomization to first use of cytotoxic chemotherapy for prostate cancer or death due to prostate cancer as assessed by the investigator. Participants not starting treatment with a cytotoxic chemotherapy or not known to have died due to prostate cancer at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.

    7. Chemotherapy-Free Survival [From randomization up to first use of cytotoxic chemotherapy for prostate cancer or death due to any cause (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)]

      Chemotherapy-free survival was defined as the time from randomization to first use of cytotoxic chemotherapy for prostate cancer or death due to any cause. Participants not starting treatment with a cytotoxic chemotherapy or not known to have died at the time of analysis were censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.

    8. Percentage of Participants With Prostate Specific Antigen (PSA) Response [From randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)]

      PSA response was calculated at each visit as a decline from baseline in PSA (ng/mL) to the maximal PSA response with thresholds at 50% and 90%. Additionally, PSA response was assessed as a decline to undetectable levels, where undetectable level was defined as below the limit of quantification of the centrally assessed PSA results (the lower limit of quantification was 0.02 ng/mL). PSA response was confirmed by a second consecutive value at least 3 weeks later.

    9. Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score [Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177]

      The FACT-P questionnaire is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess prostate-related symptoms. Each item was rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which ranged from 0 to 156 where higher scores represented better quality of life.

    10. Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Mobility Domain Score [Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177]

      EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the mobility questionnaire are reported.

    11. Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Self-Care Domain Score [Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177]

      EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ VAS. EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the self-care questionnaire are reported.

    12. Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Usual Activities Domain Score [Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177]

      EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the usual activities questionnaire are reported.

    13. Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Pain/Discomfort Domain Score [Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177]

      EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the pain/discomfort questionnaire are reported.

    14. Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Anxiety/ Depression Domain Score [Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177]

      EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the anxiety/depression questionnaire are reported.

    15. European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Status Visual Analog Score (VAS) [Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177]

      EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ VAS. EQ-5D-5L-VAS records participant's self-rated health on a vertical VAS that allows them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable), higher scores indicating a better health state.

    16. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 31 [Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177]

      The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 31 are reported. Question 31 was following: "Have you had to urinate frequently during the day?"

    17. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 32 [Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177]

      The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 32 are reported. Question 32 was following: "Have you had to urinate frequently at night?"

    18. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 33 [Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177]

      The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 33 are reported. Question 33 was following: "When you felt the urge to pass urine, did you have to hurry to get to the toilet?"

    19. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 34 [Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177]

      The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 34 are reported. Question 34 was following: "Was it difficult for you to get enough sleep, because you needed to get up frequently at night to urinate?"

    20. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 35 [Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177]

      The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 35 are reported. Question 35 was following: "Have you had difficulty going out of the house because you needed to be close to a toilet?"

    21. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 36 [Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177]

      The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 36 are reported. Question 36 was following: "Have you had any unintentional release (leakage) of urine?"

    22. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 37 [Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177]

      The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 37 are reported. Question 37 was following: "Did you have pain when you urinated?"

    23. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 38 [Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177]

      The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 38 are reported. Question 38 was following: "Has wearing an incontinence aid been a problem for you?". This question was answered by only those participants who wore incontinence aid.

    24. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 39 [Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177]

      The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 39 are reported. Question 39 was following: "Have your daily activities been limited by your urinary problems?"

    25. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 40 [Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177]

      The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 40 are reported. Question 40 was following: "Have your daily activities been limited by your bowel problems?"

    26. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 41 [Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177]

      The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 41 are reported. Question 41 was following: "Have you had any unintentional release (leakage) of stools?"

    27. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 42 [Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177]

      The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 42 are reported. Question 42 was following: "Have you had blood in your stools?"

    28. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 43 [Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177]

      The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 43 are reported. Question 43 was following: "Did you have a bloated feeling in your abdomen?"

    29. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 44 [Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177]

      The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 44 are reported. Question 44 was following: "Did you have hot flushes?"

    30. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 45 [Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177]

      The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 45 are reported. Question 45 was following: "Have you had sore or enlarged nipples or breasts?"

    31. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 46 [Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177]

      The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 46 are reported. Question 46 was following: "Have you had swelling in your legs or ankles?"

    32. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 47 [Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177]

      The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 47 are reported. Question 47 was following: "Has weight loss been a problem for you?"

    33. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 48 [Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177]

      The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 48 are reported. Question 48 was following: "Has weight gain been a problem for you?"

    34. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 49 [Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177]

      The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 49 are reported. Question 49 was following: "Have you felt less masculine as a result of your illness or treatment?"

    35. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 50 [Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177]

      The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 50 are reported. Question 50 was following: "To what extent were you interested in sex?"

    36. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 51 [Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177]

      The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 51 are reported. Question 51 was following: "To what extent were you sexually active (with or without intercourse)?"

    37. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 52 [Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177]

      The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 52 are reported. Question 52 was following: "To what extent was sex enjoyable for you?"

    38. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 53 [Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177]

      The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 53 are reported. Question 53 was following: "Did you have difficulty getting or maintaining an erection?"

    39. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 54 [Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177]

      The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 54 are reported. Question 54 was following: "Did you have ejaculation problems (e.g, dry ejaculation)?"

    40. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 55 [Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177]

      The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 55 are reported. Question 55 was following: "Have you felt uncomfortable about being sexually intimate?"

    41. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)]

      An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment-emergent AE (TEAE) was defined as an AE that occurred from the date and time of the first dose of study drug through the date of last dose +30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first). AEs included both non-serious adverse events (AEs) and SAEs.

    42. Number of Participants With Treatment-Emergent Adverse Events Greater Than or Equal to Grade 3, Based on National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE), Version 4.0 [From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)]

      An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. As per NCI CTCAE, Grade 3 events =medically significant but not immediately life-threatening, unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment, Grade 4 events =participant to be in imminent danger of death. Grade 5 events =death. A treatment-emergent AE (TEAE) was defined as an AE that occurred from the date and time of the first dose of study drug through the date of last dose +30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first).Number of participants with AEs of any of the Grade 3 or above (Grade 4, 5) were reported.

    43. Number of Participants With Discontinuations From Study Treatment Due to Adverse Events (AEs) [From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)]

      An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both non-serious adverse events (AEs) and SAEs.

    44. Number of Participants With Increase of 2 or More National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) (Version 4.0) Toxicity Grades Above Baseline - Hematology [From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)]

      Hematology parameters: Haemoglobin (grams per liter [g/L]); leukocytes (log 10 raised to power 9 per liter [10*9/L]); lymphocytes (log 10 raised to power 6 per liter [10*6/L]); neutrophils (log 10 raised to power 6 per liter [10*6/L]); platelets (log 10 raised to power 9 per litre [10*9/L]).

    45. Number of Participants With Increase of 2 or More National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) (Version 4.0) Toxicity Grades Above Baseline - Chemistry [From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)]

      Chemistry parameters: Alanine aminotransferase (units per liter [U/L]); albumin (g/L); alkaline phosphatase (U/L); bilirubin (micromoles per liter [umol/L]); calcium (millimoles per liter [mmol/L]); creatine kinase (U/L); creatinine (umol/L); glucose, magnesium, phosphate, potassium, sodium (mmol/L).

    46. Number of Participants With Clinically Significant Vital Signs [From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)]

      Vital signs included Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and heart rate.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features;

    • Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or prior bilateral orchiectomy (medical or surgical castration);

    • Testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening;

    • Progressive disease on androgen deprivation therapy at enrollment;

    • PSA and the screening PSA assessed by the central laboratory (central PSA) should be ≥ 2 µg/L (2 ng/mL:

    • PSA doubling time ≤ 10 months;

    • No prior or present evidence of metastatic disease;

    • Asymptomatic prostate cancer;

    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

    • Estimated life expectancy ≥ 12 months.

    Exclusion Criteria:
    • Prior cytotoxic chemotherapy;

    • Use of hormonal therapy or biologic therapy for prostate cancer (other than approved bone targeting agents and GnRH agonist/antagonist therapy) or use of an investigational agent within 4 weeks of randomization;

    • Known or suspected brain metastasis or active leptomeningeal disease;

    • History of another invasive cancer within 3 years of randomization;

    • Absolute neutrophil count < 1000/μL, platelet count < 100,000/μL, or hemoglobin < 10 g/dL (6.2 mmol/L) at screening;

    • Total bilirubin ≥ 1.5 times the upper limit of normal;

    • Creatinine > 2 mg/dL (177 µmol/L) at screening;

    • Albumin < 3.0 g/dL (30 g/L) at screening;

    • History of seizure or any condition that may predispose to seizure;

    • Clinically significant cardiovascular disease;

    • Gastrointestinal disorder affecting absorption;

    • Major surgery within 4 weeks of randomization;

    • Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene;

    • Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of data, in the opinion of the investigator or medical monitor.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Urological Associates of Southern Arizona, PCTucsonArizonaUnited States85741
    2Ronald Reagan UCLA Medical CenterLos AngelesCaliforniaUnited States90095
    3UCLA Clark Urology CenterLos AngelesCaliforniaUnited States90095
    4University of California, Irvine Medical CenterOrangeCaliforniaUnited States92868
    5Urology Associates of San Luis Obispo, a Medical Group, IncSan Luis ObispoCaliforniaUnited States93405
    6Urology Associates, P.C.EnglewoodColoradoUnited States80113
    7c/o Lynn BuchwalderNew HavenConnecticutUnited States06510
    8C/O Thomas Ferencz, RPh, BCOP, Smilow Cancer Hospital at Yale-New HavenNew HavenConnecticutUnited States06510
    9Smilow Cancer Center at Yale New Haven-HospitalNew HavenConnecticutUnited States06510
    10Yale New Haven HospitalNew HavenConnecticutUnited States06510
    11Yale University School of MedicineNew HavenConnecticutUnited States06520
    12Lakeland Regional Cancer CenterLakelandFloridaUnited States33805
    13Urology of Indiana, LLCCarmelIndianaUnited States46032
    14First Urology, PSCJeffersonvilleIndianaUnited States47130
    15IU Health Arnett Cancer CareLafayetteIndianaUnited States47904
    16Kansas City Urology Care, PAOverland ParkKansasUnited States66211-1231
    17GU Research Network/ Wichita Urology GroupWichitaKansasUnited States67226
    18Chesapeake Urology Research AssociatesBaltimoreMarylandUnited States21237
    19University of Michigan Health SystemAnn ArborMichiganUnited States48109
    20Michigan Institute of UrologyTroyMichiganUnited States48084
    21GU Research NetworkOmahaNebraskaUnited States68130
    22Brooklyn Urology Research GroupBrooklynNew YorkUnited States11201
    23Premier Medical Group of the Hudson ValleyNewburghNew YorkUnited States12550
    24Duke University Medical CenterCaryNorth CarolinaUnited States27518
    25Carolina Urology Partners, PLLCCharlotteNorth CarolinaUnited States28277
    26Carolina Urology Partners, PLLCGastoniaNorth CarolinaUnited States28054
    27Gaston Medical AssociatesGastoniaNorth CarolinaUnited States28054
    28Carolina Urology Partners, PLLCHuntersvilleNorth CarolinaUnited States28078
    29Duke Women's Cancer Care RaleighRaleighNorth CarolinaUnited States27607
    30Clinical Research SolutionsMiddleburg HeightsOhioUnited States44130
    31Oregon Urology InstituteSpringfieldOregonUnited States97477
    32Lancaster UrologyLancasterPennsylvaniaUnited States17604
    33Carolina Urologic Research CenterMyrtle BeachSouth CarolinaUnited States29572
    34Vanderbilt University Medical Center, Dept. of Urologic SurgeryNashvilleTennesseeUnited States37232
    35Vanderbilt University Medical Center, The Urologic ClinicNashvilleTennesseeUnited States37232
    36Urology San AntonioSan AntonioTexasUnited States78229
    37Urology of Virginia, PLLCVirginia BeachVirginiaUnited States23462
    38COIBA(Centro de Oncologia e Investigacion Buenos Aires)BerazateguiBuenos AiresArgentinaB1884BBF
    39Centro Medico Austral(OMI)CabaBuenos AiresArgentinaC1019ABS
    40Centro de UrologiaCabaBuenos AiresArgentinaC1120AAT
    41Hospital Italiano de Buenos AiresCabaBuenos AiresArgentinaC1199BB
    42Sanatorio ParqueRosarioSanta FEArgentinaCP2000
    43Instituto De Oncologia De RosarioRosarioSanta FEArgentinaS200KZE
    44Clinica Universidad Reina FabiolaCordobaArgentinaX5004HFP
    45Hospital Privado Centro Medico de CordobaCordobaArgentinaX5016KEH
    46Centro Oncologico Riojano Integral (CORI)La RiojaArgentinaF5300C0E
    47The Canberra HospitalGarranAustralian Capital TerritoryAustralia2605
    48Border Medical Oncology Research UnitAlburyNew South WalesAustralia2640
    49The Border Cancer Hospital DispensaryAlburyNew South WalesAustralia2640
    50The Border Cancer HospitalAlburyNew South WalesAustralia2640
    51Sydney cancer centreConcordNew South WalesAustralia2139
    52Epic pharmacyLismoreNew South WalesAustralia2480
    53North Coast Cancer InstituteLismoreNew South WalesAustralia2480
    54Macquarie University HospitalNorth RydeNew South WalesAustralia2109
    55Macquarie UniversityNorth RydeNew South WalesAustralia2109
    56Epic Pharmacy Port Macquarie base hospitalPort MacquarieNew South WalesAustralia2444
    57Mid North Coast Cancer InstitutePort MacquarieNew South WalesAustralia2444
    58Royal North Shore HospitalSt LeonardsNew South WalesAustralia2065
    59The Tweed HospitalTweed HeadsNew South WalesAustralia2485
    60Australian Clinical TrialsWahroongaNew South WalesAustralia2076
    61Sydney Adventist HospitalWahroongaNew South WalesAustralia2076
    62Calvary Mater NewcastleWaratahNew South WalesAustralia2298
    63Westmead HospitalWestmeadNew South WalesAustralia2145
    64Icon Cancer Care WesleyAuchenflowerQueenslandAustralia4066
    65River City Pharmacy - APHSAuchenflowerQueenslandAustralia4066
    66Icon Cancer Care ChermsideChermsideQueenslandAustralia4032
    67Icon Cancer Care South BrisbaneSouth BrisbaneQueenslandAustralia4101
    68Integrated Clinical Oncology Network (ICON)South BrisbaneQueenslandAustralia4101
    69Icon Cancer Care SouthportSouthportQueenslandAustralia4215
    70Tasman Oncology Research Pty LtdSouthportQueenslandAustralia4215
    71Princess Alexandra HospitalWoolloongabbaQueenslandAustralia4102
    72Adelaide Cancer CentreKurralta ParkSouth AustraliaAustralia5037
    73Ashford Cancer Centre ResearchKurralta parkSouth AustraliaAustralia5037
    74Cancer Care SA Pty LtdKurralta ParkSouth AustraliaAustralia5037
    75Tenpharm Pty Ltd trading as EPIC Pharmacy TennysonKurralta ParkSouth AustraliaAustralia5037
    76Box Hill Hospital (Eastern health)Box HillVictoriaAustralia3128
    77Eastern Clinical Research Unit (Eastern Health)Box HillVictoriaAustralia3128
    78Cabrini Hospital BrightonBrightonVictoriaAustralia3186
    79Monash Medical CentreClaytonVictoriaAustralia3168
    80Austin Health, Austin HospitalHeidelbergVictoriaAustralia3084
    81Cabrini Hospital MalvernMalvernVictoriaAustralia3144
    82Cabrini Hospital- Education and Research PrecinctMalvernVictoriaAustralia3144
    83Peter MacCallum Cancer CentreMelbourneVictoriaAustralia3000
    84Sunshine HospitalSt AlbansVictoriaAustralia3021
    85Krankenhaus Barmherzige Schwestern Linz, Abteilung RadiologieLinzUpper AustriaAustria4010
    86Krankenhaus Barmherzige Schwestern Linz, Abteilung UrologieLinzUpper AustriaAustria4010
    87St. Vincent's Hospital, PET - CT CenterLinzUpper AustriaAustria4010
    88Isotopix, Ambulatorium fuer NuklearmedizinViennaAustria1090
    89Medizinische Universitaet Wien, Universitaetsklinik fuer Innere Medizin IViennaAustria1090
    90Diagnosezentrum Meidling GesmbHViennaAustria1120
    91Algemeen Ziekenhuis GroeningeKortrijkWest-vlaanderenBelgium8500
    92Clinique Universitaire de Bruxelles Hopital ErasmeBruxellesBelgium1070
    93Vzw Algemeen Ziekenhuis Maria MiddelaresGentBelgium9000
    94Universitaire Ziekenhuizen LeuvenLeuvenBelgium3000
    95Centre Hospitalier Universitaire de Liege, Site du Sart-TilmanLiegeBelgium4000
    96Hospital Sao RafaelSalvadorBahiaBrazil41253-190
    97Liga Paranaense de Combate ao cancer / Hospital Erasto GaertnerCuritibaParanaBrazil81520-060
    98Associacao Hospital de Caridade de IjuiIjuiRIO Grande DO SULBrazil98700-000
    99Hospital da Cidade de Passo FundoPasso FundoRIO Grande DO SULBrazil99010-260
    100Hospital de Clinicas de Porto AlegrePorto AlegreRIO Grande DO SULBrazil90035-903
    101CLINIONCO - Clinica de Oncologia de Porto Alegre Ltda.Porto AlegreRIO Grande DO SULBrazil90430-090
    102Hospital Sao Lucas da PUCRSPorto AlegreRIO Grande DO SULBrazil90610-000
    103Instituto D'or de Pesquisa e EnsinoRio de JaneiroRJBrazil22.281-100
    104Hospital Amaral Carvalho - Fundacao Dr. Amaral CarvalhoJauSAO PauloBrazil17210-080
    105Fundacao Dr. Amaral CarvalhoJauSAO PauloBrazil17210-120
    106Fundacao Dr.Amaral CarvalhoJauSAO PauloBrazil17210-120
    107Hospital Israelita Albert EinsteinSao PaulpSAO PauloBrazil05652-900
    108Hospital das Clinicas da Faculdade de Ciencias Medicas da UNICAMPCampinasSPBrazil13083-970
    109Centro de Estudos e Pesquisas em Hematologia e Oncologia (CEPHO)Santo AndreSPBrazil09060-650
    110IAMSPE-Inst. de Assist. ao Servidor Publico EstadualSao PauloSPBrazil04039-901
    111Hospital Universitario Pedro Ernesto - UERJRio de JaneiroBrazil20551-030
    112Oncologia Rede D'OrRio de JaneiroBrazil22271-110
    113Tom Baker Cancer CentreCalgaryAlbertaCanadaT2N 4N2
    114Cross Cancer InstituteEdmontonAlbertaCanadaT6G 1Z2
    115Vancouver Prostate CentreVancouverBritish ColumbiaCanadaV5Z 1M9
    116Manitoba Prostate Centre CancerCare ManitobaWinnipegManitobaCanadaR3E 0V9
    117NS Health Authority, Queen Elizabeth II Health Sciences CentreHalifaxNova ScotiaCanadaB3H 2Y9
    118The Male/Female Health and Research CentreBarrieOntarioCanadaL4M 7G1
    119McMaster Institute of Urology @ St. Joseph's Healthcare HamiltonHamiltonOntarioCanadaL8N 4A6
    120Urology Associates / Urologic Medical ResearchKitchenerOntarioCanadaN2N 2B9
    121London Regional Cancer Program - Victoria Hospital, London Health Sciences Centre(LHSC)LondonOntarioCanadaN6A 4L6
    122Urology Reasearch - Victoria Hospital, London Health Sciences Centre(LHSC)LondonOntarioCanadaN6A 5W9
    123SunnyBrook Health Sciences CentreTorontoOntarioCanadaM4N 3M5
    124University Health Network- Princess Margaret Cancer CentreTorontoOntarioCanadaM5G2M9
    125Urology South Shore ResearchGreenfield ParkQuebecCanadaJ4V 2H3
    126Centre Hospitalier de l'Universite de MontrealMontrealQuebecCanadaH2X 3E4
    127McGill University Health CentreMontrealQuebecCanadaH4A 3J1
    128CHU de QuebecQuebecCanadaG1R 2J6
    129Fundacion Arturo Lopez PerezSantiagoChile7500836
    130Centro de Investigaciones Clinicas Vina del MarSantiagoChile7630370
    131Instituto Clinico Oncologico del Sur (ICOS)TemucoChile4810469
    132Instituto Oncologico Ltda.Vina del MarChile2540364
    133Centro de Investigaciones ClinicasVina del MarChile2540488
    134Peking University First HospitalBeijingBeijingChina100034
    135Beijing Cancer HospitalBeijingBeijingChina100142
    136Peking University Third HospitalBeijingBeijingChina100191
    137Beijing HospitalBeijingBeijingChina100730
    138Peking Union Medical College HospitalBeijingBeijingChina100730
    139Chongqing Cancer HospitalChongqingChongqingChina400030
    140The First Affiliated Hospital of Guangzhou Medical UniversityGuangzhouGuangdongChina510120
    141Zhongnan Hospital of Wuhan UniversityWuhanHubeiChina430030
    142Office of Hongqian GuoNanjingJiangsuChina210008
    143Jiangsu Cancer HospitalNanjingJiangsuChina210009
    144Jiangsu Province HospitalNanjingJiangsuChina210029
    145The Second Affiliated Hospital of Soochow UniversitySuzhouJiangsuChina215004
    146Wuxi People's HospitalWuxiJiangsuChina214023
    147Qingdao Municipal Hospital (East Hospital)QingdaoShandongChina266071
    148Fudan University Shanghai Cancer CenterShanghaiShanghaiChina200032
    149Huashan Hospital Fudan UniversityShanghaiShanghaiChina200040
    150Shanghai First People's HospitalShanghaiShanghaiChina200080
    151Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineShanghaiShanghaiChina200092
    152Shanghai Changhai HospitalShanghaiShanghaiChina200433
    153The First Affiliated Hospital of Xi'an Jiaotong UniversityXi'anShanxiChina710061
    154The Second Affiliated Hospital of Zhejiang University School of MedicineHangzhouZhejiangChina310009
    155The First Affiliated Hosptial of Wenzhou Medical UniversityWenzhouZhejiangChina325000
    156UNIMED Medical Institute LimitedHong KongChina
    157The Second Hospital of Tianjin Medical UniversityTianjinChina300211
    158Rigshospitalet 7521CopenhagenNorrebroDenmark2200
    159Copenhagen Prostate Cancer CenterCopenhagenNDenmark2200
    160Aarhus University HospitalArhus NDenmark8200
    161RigshospitaletCopenhagenDenmark2100
    162Frederiksberg HospitalFrederiksbergDenmark2000
    163Herlev HospitalHerlevDenmark2730
    164Odense University HospitalOdense CDenmark5000
    165Vejle SygehusVejleDenmark7100
    166Docrates SyopasairaalaHelsinkiFinland00180
    167Helsingin yliopistollinen keskussairaala, Meilahden sairaalaHelsinkiFinland00290
    168Oulun yliopistollinen sairaalaOuluFinland90220
    169Satakunnan keskussairaalaPoriFinland28500
    170Tampereen yliopistollinen SairaalaTampereFinland33520
    171Hopitaux Universitaires de Strasbourg - Hopital CivilSTRASBOURG CedexAlsaceFranceFR-67091
    172Centre Paul StraussStrasbourgBas-rhinFrance67000
    173Clinique Sainte AnneStrasbourgBas-rhinFrance67000
    174Societe MIM, Clinique Sainte AnneStrasbourgBas-rhinFrance67000
    175Institut CurieParis CedexParisFrance75005
    176Centre Hospitalier Lyon SudPierre Benite CedexRhoneFrance69495
    177Institut Gustave RoussyVillejuif CedexVAL DE MarneFrance94805
    178Institut de Cancerologie de l'Ouest - Paul PapinAngers Cedex 2France49055
    179Institut Sainte CatherineAvignon, Cedex 9France84918
    180Institut BergonieBordeaux CedexFrance33076
    181Urologic Oncology Department- Institut Bergonie - Centre regional de Lutte contre le CancerBordeaux CedexFrance33076
    182Cabinet de RadiologieBrestFrance29200
    183CHU Brest Hopital MorvanBrestFrance29200
    184Clinique pasteur LancrozeBrestFrance29200
    185Clinique Pasteur-LanrozeBrestFrance29200
    186CHRU de BrestBrestFrance29609
    187Hopital PasteurColmar CedexFrance68024
    188Hopitaux Civils de ColmarColmarFrance68024
    189Centre Regional de lutte Contre le Cancer Georges Francois LeclercDijonFrance21000
    190Clinique Victor HugoLe Mans,CedexFrance72000
    191Hopital Calude Huriez - CHU LilleLilleFrance59037
    192Hopital Edouard Herriot - CHU LyonLyon Cedex 03France69437
    193Centre Leon BerardLyon CedexFrance69008
    194Centre de Medecine Nucleaire LUMENLyonFrance69008
    195Hopital NordMarseilleFrance13915 Cedex 20
    196ICM Val D'AurelleMontpellier CedexFrance34298
    197Hopital Europeen Georges PompidouParis, Cedex 15France75908
    198Centre Hospitalier Lyon SudPierre BeniteFrance69495
    199CHU Poitiers - Hopital la MiletriePoitiers, CedexFrance86021
    200Institut de Cancerologie de I'Ouest - Rene GauducheauSaint-Herblain CedexFrance44805
    201Clinique Pasteur - CIMOFToulouse Cedex 3France31076
    202Clinique Pasteur- Service Imagerie et RadiologieToulouse Cedex 3France31076
    203Clinique PasteurToulouse Cedex 3France31076
    204IUCT-OncopoleToulouse Cedex 9France31059
    205Institut Claudius RegaudToulouseFrance31059 Cedex 9
    206Studienpraxis UrologieNuertingenBaden-wuerttembergGermany72622
    207Universitatsmedizin Mannheim, Medizinische Fakultat Mannheim der Universitat HeidelbergMannheimBaden-wurttembergGermany68167
    208MVZ Zentrum fuer Diagnostische Radiologie und Nuklearmedizin Braunschweig GmbHBraunschweigNiedersachsenGermany38102
    209Staedtisches Klinikum BraunschweigBraunschweigNiedersachsenGermany38126
    210Hannover Medical SchoolHannoverNiedersachsenGermany30625
    211Medizinische Hochschule HannoverHannoverNiedersachsenGermany30625
    212RWTH University AachenAachenNordrhein-westfalenGermany52057
    213Uniklinik der RWTH AachenAachenNordrhein-westfalenGermany52074
    214Clinic of RadiologyAachenNordrhein-westfalenGermanyD-52074
    215Universitaetsklinikum Carl Gustav Carus an der TU DresdenDresdenSaxonyGermany01307
    216Charite, Campus Benjamin FranklinBerlinGermany12200
    217Charite, Universitaetsmedizin BerlinBerlinGermany12200
    218Martini-Klinik am UKE GmbHHamburgGermany20246
    219Diagnostikzentrum EsslingenKirchheimGermany73230
    220University General Hospital of Heraklion, Urology ClinicHeraklionCreteGreece71110
    221General Hospital of Athens"Korgialeneio-Benakeio EES".Urology ClinicAthensGreece11526
    222General Hospital of Athens "Alexandra", Therapeutic ClinicAthensGreece11528
    223University General Hospital of Larissa, Urology DepartmentLarissaGreece41110
    224University General Hospital of Patras, Oncology Department, Internal Medicine ClinicPatraGreece26504
    225General Hospital" Papageorgiou",B' Univ.Urology ClinicThessalonikiGreece56429
    226Queen Mary HospitalHong KongHong Kong
    227Tuen Mun HospitalHong KongHong Kong
    228Prince of Wales HospitalShatinHong Kong
    229Laboratorio Medicina Nucleare-Ospedale G.B. Morgagni-PierantoniForliFCItaly47121
    230Farmacia, Azienda Socio Sanitaria Territoriale di CremonaCremonaItaly26100
    231Medicina Nucleare, Azienda Socio Sanitaria Territoriale di CremonaCremonaItaly26100
    232Servizio di Radiologia, Azienda Socio Sanitaria Territoriale di CremonaCremonaItaly26100
    233Struttura Complessa di Oncologia, Azienda Socio Sanitaria Territoriale di CremonaCremonaItaly26100
    234U.O. di Oncologia, Ospedale Civile Degli InfermiFaenza (RA)Italy48018
    235U.O. di Radiologia, Ospedale Civile degli InfermiFaenza (RA)Italy48018
    236U.O. di Oncologia, Ospedale Civile Umberto ILugo (RA)Italy48022
    237U.O. di Radiologia, Ospedale Civile Umberto ILugo (RA)Italy48022
    238Laboratorio Farmaci AntiblasticiMeldola (FC)Italy47014
    239U.O. Oncologia MedicaMeldola (FC)Italy47014
    240UO RadiologiaMeldola (FC)Italy47014
    241Dipartimento di Radiologia, Ospedale San RaffaeleMilanoItaly20132
    242Servizio di Farmacia, Ospedale San RaffaeleMilanoItaly20132
    243U.O. di Medicina Nucleare e Centro PET, Ospedale San RaffaeleMilanoItaly20132
    244U.O. di Urologia, Ospedale San RaffaeleMilanoItaly20132
    245Farmacia Studi Clinici e Sperimentali, Fondazione IRCCS Istituto Nazionale dei TumoriMilanoItaly20133
    246S.C. di Oncologia Medica 1, Fondazione IRCCS Istituto Nazionale dei TumoriMilanoItaly20133
    247S.C. Diagnostica Radiologica 2, Fondazione IRCCS Istituto Nazionale dei TumoriMilanoItaly20133
    248Divisione di Radiologia, Istituto Europeo di OncologiaMilanoItaly20141
    249Reparto Oncologia Medica Urogenitale e Cervico Facciale, Istituto Europeo di OncologiaMilanoItaly20141
    250Servizio Farmacia, Istituto Europeo di OncologiaMilanoItaly20141
    251Farmacia Interna, Azienda Ospedaliero-Universitaria Policlinico di ModenaModenaItaly41124
    252Medicina Nucleare, Azienda Ospedaliero-Universitaria Policlinico di ModenaModenaItaly41124
    253Radiologia I, Azienda Ospedaliero-Universitaria Policlinico di ModenaModenaItaly41124
    254U.O.S.C. di Oncologia Medica, A.O.R.N. "A. Cardarelli"NapoliItaly80131
    255Farmacia Ospedaliera, AOU San Luigi GonzagaOrbassano (TO)Italy10043
    256SCDU Oncologia Medica II Pad, AOU San Luigi GonzagaOrbassano (TO)Italy10043
    257SCDU Radiodiagnostica, AOU San Luigi GonzagaOrbassano (TO)Italy10043
    258SS Medicina Nucleare, AOU San Luigi GonzagaOrbassano (TO)Italy10043
    259Farmacia, Istituto Oncologico Veneto (IOV)PadovaItaly35128
    260IRCCS - Istituto Oncologico Veneto (IOV), UOC Oncologia Medica 1PadovaItaly35128
    261Medicina Nucleare, Istituto Oncologico Veneto (IOV)PadovaItaly35128
    262UOC Radiodiagnostica Oncologica, Istituto Oncologico Veneto (IOV)PadovaItaly35128
    263Ospedale Santa Maria delle CrociRavennaItaly48121
    264Servizio di Farmacia, AUSL di RavennaRavennaItaly48121
    265Servizio di Radiologia, AUSL di RavennaRavennaItaly48121
    266Azienda Ospedaliera S. Camillo Forlanini, UOC per il governo clinico in Oncologia MedicaRomaItaly00152
    267U.O. di Oncologia Medica, Ospedale Santa ChiaraTrentoItaly38122
    268U.O. Farmacia, Ospedale Santa ChiaraTrentoItaly38122
    269U.O. Radiologia, Ospedale Santa ChiaraTrentoItaly38122
    270National Cancer CenterGoyang-siGyeonggi-doKorea, Republic of10408
    271Chonnam National University Hwasun HospitalHwasun-gunJeonnamKorea, Republic of58128
    272Gachon University Gil Medical CenterIncheonKorea, Republic of21565
    273Seoul National University HospitalSeoulKorea, Republic of03080
    274Severance Hospital, Yonsei University Health SystemSeoulKorea, Republic of03722
    275Asan Medical CenterSeoulKorea, Republic of05505
    276Gangnam Severance Hospital, Yonsei University Health SystemSeoulKorea, Republic of06273
    277Samsung Medical CenterSeoulKorea, Republic of06351
    278Universiti Kebangsaan Malaysia Medical CentreCherasKuala LumpurMalaysia56000
    279Sarawak General HospitalKuchingSarawakMalaysia93586
    280Subang Jaya Medical Centre Sdn. Bhd.Subang JayaSelangor Darul EhsanMalaysia47500
    281Hospital Kuala LumpurKuala LumpurMalaysia50586
    282University Malaya Medical CentreKuala LumpurMalaysia59100
    283Maastricht University Medical CentreMaastrichtAZNetherlands5202
    284Catharina ZiekenhuisEindhovenNoord-brabantNetherlands5623 EJ
    285Netherlands Cancer InstituteAmsterdamNetherlands1066 CX
    286Albert Schweitzer ZiekenhuisDordrechtNetherlands3318 AT
    287University Medical Center GroningenGroningenNetherlands9700 RB
    288Radboud University Nijmegen Medical CentreNijmegenNetherlands6525 GA
    289Canterbury District Health BoardChristchurchCanterburyNew Zealand8140
    290Palmerston North HospitalPalmerston NorthManawatuNew Zealand4414
    291Cancer and Blood ResearchAucklandNew Zealand1023
    292Waikato Urology Research LTDHamiltonNew Zealand3214
    293Uniwersyteckie Centrum KliniczneGdanskPoland80-952
    294UROMEDYK, Poradnia UrologicznaKielcePoland25-112
    295Malopolskie Centrum Medyczne s.c.KrakowPoland30-510
    296Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZLublinPoland20-718
    297Wojewodzki Szpital Specjalistyczny im. Janusza. KorczakaSlupskPoland76-200
    298Profesorskie Centrum Medyczne OptimumWroclawPoland50-421
    299Centrum Medyczne Melita MedicalWroclawPoland50-449
    300Wro MedicaWroclawPoland51-685
    301LexmedicaWroclawPoland53-114
    302Federal State Budgetary Institution "N.N. Blokhin Russian Cancer Research Center"MoscowRussian Federation115478
    303P. Hertsen Moscow Oncology Research Institute - branch of the National Medical ResearchMoscowRussian Federation125284
    304State Budgetary Healthcare Institution City Multifield Hospital No.2Saint-PetersburgRussian Federation194354
    305SBEI HPE "First Pavlov State Medical University of St. Petersburg" ofSaint-PetersburgRussian Federation197002
    306SBEI HPE "First Pavlov State Medical University of St. Petersburg" ofSaint-PetersburgRussian Federation197022
    307Saint-Petersburg State Budgetary Healthcare Institution "Hospital for Veterans of War"Saint-PetersburgRussian Federation197183
    308SBHI "Saint-Petersburg clinical scientificSaint-PetersburgRussian Federation197758
    309SBEI of HPE "Bashkir State Medical University" of MoH of the RFUfaRussian Federation450073
    310Clinical Center Of Serbia, Clinic of UrologyBelgradeSerbia11000
    311Clinical Center "Dr Dragisa Misovic -Dedinje", Clinic of UrologyBelgradeSerbia11040
    312Clinical Center "Bezanijska Kosa", Department of UrologyBelgradeSerbia11080
    313Clinical Center ZemunBelgradeSerbia11080
    314National University HospitalSingaporeSingapore119074
    315National Cancer Centre SingaporeSingaporeSingapore169610
    316Fakultna nemocnica s poliklinikou F.D. RooseveltaBanska BystricaSlovakia975 17
    317Institut nuklearnej a molekularnej medicinyBanska BystricaSlovakia975 17
    318Bratislavske radiodiagnosticke centrum, a.s.BratislavaSlovakia814 99
    319CUIMED, s.r.o., Urologicka ambulanciaBratislavaSlovakia851 05
    320Vychodoslovensky onkologicky ustav, a.s.KosiceSlovakia041 91
    321Vychodoslovensky onkologicky ustav, a.s.KosiceSlovakia04191
    322Institut nuklearnej a molekularnej medicinyKosiceSlovakia042 53
    323Univerzitna nemocnica MartinMartinSlovakia036 59
    324IZOTOPCENTRUM, s.r.o.NitraSlovakia949 01
    325Jessenius-diagnosticke centrum, a.s.NitraSlovakia949 01
    326UROEXAM spol. s r.o. urologicka ambulanciaNitraSlovakia949 01
    327Alfamedis, s.r.o.PresovSlovakia080 01
    328MILAB s.r.o., UROCENTRUMPresovSlovakia080 01
    329Vivamed, s.r.oPresovSlovakia080 01
    330UVN SNP - FN Ruzomberok, Pracovisko Nuklearnej mediciny CCSRRuzomberokSlovakia034 26
    331Fakultna nemocnica s Poliklinikou Skalica a.sSkalicaSlovakia909 82
    332GAMMALAB, spol. s.r.o., Oddelenie nuklearnej medicinyTrnavaSlovakia917 01
    333GAMMALAB, spol.s.r.o., Oddelenie nuklearnej medicinyTrnavaSlovakia917 01
    334KK MED s.r.o.ZilinaSlovakia010 01
    335Fakultna nemocnica s poliklinikou Zilina, Urologicke oddelenieZilinaSlovakia012 07
    336Hospital Clinico Universitario de Santiago de CompostelaSantiago de CompostelaA CorunaSpain15706
    337Hospital Universitari Son Espases,Palma de MallorcaBalearesSpain07010
    338Hospital Germans Trias i PujolBadalonaBarcelonaSpain08916
    339ALTAHIA. Xarxa Assistencial Universitaria de ManresaManresaBarcelonaSpain08243
    340Hospital Universitario Parc TauliSabadellBarcelonaSpain08208
    341ICO Girona-Hospital Universitari de Girona Dr. Josep TruetaGeronaCatalunaSpain17007
    342Hospital de NavarraPamplonaNavarraSpain31008
    343Complejo Hospitalario Universitario A CorunaA CorunaSpain15006
    344Hospital Del MarBarcelonaSpain08003
    345Cetir Centre Medic, S.L.BarcelonaSpain08029
    346Hospital Clinic de BarcelonaBarcelonaSpain08036
    347Hospital Universitario de la PrincesaMadridSpain28006
    348MD Anderson Cancer CenterMadridSpain28033
    349Hospital Universitario 12 de octubreMadridSpain28041
    350UrologmottagningenGoteborgSweden41345
    351Diagnostiskt centrum for bild- och funktionsmedicinMalmoSweden205 02
    352Urologiska KlinikenMalmoSweden20502
    353Apoteket AB Kliniska Provningar MolnlyckeMolnlyckeSweden435 33
    354Karolinska UniversitetssjukhusetSolnaSweden17164
    355UrologmottagningenStockholmSweden11853
    356UrologklinikenUmeaSweden90185
    357Urologiska KlinikenÖrebroSweden70185
    358Chang Gung Medical Fundation, Chiayi Branch(Chiayi Chang Gung Memorial Hospital)Chiayi CountyTaiwan613
    359Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiungTaiwan807
    360Kaohsiung Veterans General HospitalKaohsiungTaiwan81362
    361Chang Gung Medical Fundation,Kaohsiung (Kaohsiung Chang Gung Memorial Hospital)KaohsiungTaiwan830
    362Chang Gung Memorial Hospital, Keelung Branch (Keelung Chang Gung Memorial Hospital)Keelung CityTaiwan204
    363China Medical University HospitalTaichungTaiwan40447
    364Taichung Veterans General HospitalTaichungTaiwan40705
    365Chi Mei Medical CentreTainan CityTaiwan710
    366National Taiwan University HospitalTaipeiTaiwan100
    367Taipei Veterans General HospitalTaipeiTaiwan11217
    368Chang-Gung Memorial Hospital at LinkuoTaoyuan CountyTaiwan333
    369Maharaj Nakorn Chiang Mai HospitalMuangChiang MAIThailand50200
    370Songklanagarind HospitalHat YaiSongklaThailand90110
    371King Chulalongkorn Memorial Hospital, Chulalongkorn UniversityBangkokThailand10330
    372Rajavithi HospitalBangkokThailand10400
    373Cukurova Universitesi Tip FakultesiAdanaTurkey01330
    374Hacettepe Universitesi Tip FakultesiAnkaraTurkey06100
    375Istanbul Universitesi Cerrahpasa Tip FakultesiIstanbulTurkey34098
    376Izmir Bozyaka Egitim Arastirma HastanesiIzmirTurkey35170
    377Celal Bayar Universitesi Tip FakultesiManisaTurkey45030
    378RCI Chernivtsi Regional Clinical HospitalChernivtsiUkraine58002
    379CI Dnipropetrovsk I.I. Mechnykov RCH, Department of Urology #2DnipropetrovskUkraine49005
    380CHI V.I.Shapoval RCC of Urology and Nephrology, Dep. Of Urology#4KharkivUkraine61037
    381Kyiv City Clinical Hospital #3, Department of UrologyKyivUkraine02125
    382Central City Clinical Hospital, City Oncological CenterUzhgorodUkraine88000
    383CI Zaporizhzhia Regional Clinical Hospital, Dep. Of Urology,ZaporizhzhiaUkraine69600
    384East and North Hertfordshire NHS TrustNorthwoodMiddlesexUnited KingdomHA6 2RN
    385Belfast Health and Social Care TrustBelfastNorthern IrelandUnited KingdomBT9 7AB
    386Royal Marsden NHS Foundation TrustSuttonSurreyUnited KingdomSM2 5PT
    387The Newcastle upon Tyne Hospitals NHS Foundation TrustNewcastle upon TyneTyne and WearUnited KingdomNE7 7DN
    388University Hospitals Birmingham NHS Foundation TrustBirminghamUnited KingdomB15 2TH
    389University Hospitals Birmingham NHS Foundation TrustBirminghamUnited KingdomB15 2WB
    390University Hospitals Bristol NHS Foundation TrustBristolUnited KingdomBS2 8ED
    391University Hospitals Bristol NHS Foundation TrustBristolUnited KingdomBS2 8HW
    392Cambridge University Hospitals NHS Foundation TrustCambridgeUnited KingdomCB2 0QQ
    393University College Hospitals NHS TrustLondonUnited KingdomNW1 2BU
    394Imperial College Healthcare NHS TrustLondonUnited KingdomW12 0HS
    395University College London Hospitals NHS Foundation TrustLondonUnited KingdomWC1E 6AG
    396The Christie NHS Foundation TrustManchesterUnited KingdomM20 4BX
    397Oxford University Hospitals NHS TrustOxfordUnited KingdomOX3 7LE

    Sponsors and Collaborators

    • Pfizer
    • Astellas Pharma Inc
    • Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

    Investigators

    • Study Director: Pfizer Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT02003924
    Other Study ID Numbers:
    • MDV3100-14
    • C3431005
    • 2012-005665-12
    First Posted:
    Dec 6, 2013
    Last Update Posted:
    Oct 7, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment DetailsThe study was conducted at 254 sites in 32 countries.
    Pre-assignment DetailA protocol amendment was implemented to unblind all participants and those who were previously treated with placebo had an opportunity to receive open-label access to enzalutamide at the discretion of the investigator.
    Arm/Group TitleEnzalutamide 160 mgPlaceboPlacebo Participants Crossover to Enzalutamide 160 mg
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.Participants who received placebo in double-blind phase and who agreed to proceed to open-label phase, received 4 capsules of Enzalutamide 40 mg each (total dose of 160 mg per day), orally once daily (up to a maximum of 18.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Period Title: Double-blind Phase
    STARTED9334680
    Treated9304650
    COMPLETED478870
    NOT COMPLETED4553810
    Period Title: Double-blind Phase
    STARTED478087
    Treated478087
    COMPLETED378070
    NOT COMPLETED100017
    Period Title: Double-blind Phase
    STARTED93338187
    COMPLETED56614480
    NOT COMPLETED3672377

    Baseline Characteristics

    Arm/Group TitleEnzalutamide 160 mgPlaceboTotal
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.Total of all reporting groups
    Overall Participants9334681401
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    73.8
    (7.83)
    72.9
    (7.63)
    73.5
    (7.77)
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    0
    0%
    0
    0%
    Male
    933
    100%
    468
    100%
    1401
    100%
    Race/Ethnicity, Customized (Count of Participants)
    Asian
    142
    15.2%
    88
    18.8%
    230
    16.4%
    Black or African American
    21
    2.3%
    10
    2.1%
    31
    2.2%
    Native Hawaiian or Other Pacific Islander
    3
    0.3%
    2
    0.4%
    5
    0.4%
    White
    671
    71.9%
    320
    68.4%
    991
    70.7%
    Multiple
    4
    0.4%
    4
    0.9%
    8
    0.6%
    Other
    15
    1.6%
    5
    1.1%
    20
    1.4%
    Missing
    77
    8.3%
    39
    8.3%
    116
    8.3%

    Outcome Measures

    1. Primary Outcome
    TitleMetastasis Free Survival (MFS)
    DescriptionMFS:time from randomization to first date of radiographic progression (RP) (by Blinded independent central radiology review [BICR]) at any time or death within 112 days of treatment discontinuation without evidence of RP.RP for bone disease:appearance of 1 or more metastatic lesions on bone scan.RP for soft tissue disease:per Response Evaluation Criteria in Solid Tumors,[RECIST 1.1])-at least a 20 percent (%) increase in the sum of diameters of target lesions,taking as reference the smallest sum on study (includes the baseline sum if smallest on study).Participants who did not have MFS event at the time of analysis data cut-off (28 June 2017) were censored at date of last assessment showing no objective evidence of RP prior to skeletal-related event or two or more consecutive missed tumor assessments. Participants who were randomized but later confirmed to have metastatic disease before randomization were censored on date of randomization. Analysis was based on Kaplan-Meier estimates.
    Time FrameFrom randomization until radiographic progression at any time, or death within 112 days of treatment discontinuation, whichever occurred first (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)

    Outcome Measure Data

    Analysis Population Description
    The intent-to-treat (ITT) population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Median (95% Confidence Interval) [months]
    36.6
    14.7
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Enzalutamide 160 mg, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value<0.0001
    CommentsP-value was based on stratified log-rank test by prostate-specific antigen (PSA) doubling time (< 6 months, >= 6 months) and prior or concurrent use of a bone targeting agent (yes, no). Threshold for significance at 0.05 level.
    MethodLog Rank
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value0.292
    Confidence Interval (2-Sided) 95%
    0.241 to 0.352
    Parameter Dispersion Type:
    Value:
    Estimation CommentsHR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with < 1 favoring Enzalutamide.
    2. Secondary Outcome
    TitleTime to Prostate-Specific Antigen (PSA) Progression
    DescriptionTime to PSA progression was defined as the time from randomization to the date of first PSA value demonstrating progression, which was subsequently confirmed. For participants with PSA decline at Week 17, PSA progression was defined according to Prostate Cancer Working Group 2 (PCWG2) guidelines as the date that a 25% or greater increase and an absolute increase of 2 nanograms per milliliter (ng/mL) above the nadir (or baseline for participants with no PSA decline by Week 17) was documented, which was confirmed by a second consecutive value obtained at least 3 weeks or later. Participants without confirmed PSA progression at the time of analysis were right censored at the date of last PSA assessment before the analysis data cut-off date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.
    Time FrameFrom randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Median (95% Confidence Interval) [months]
    37.2
    3.9
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Enzalutamide 160 mg, Placebo
    Comments To maintain the family-wise 2-sided type I error rate at 0.05, a parallel testing strategy between OS (with allocated type I error rate 0.03) and remaining key secondary endpoints (time to PSA progression and time to first use of new antineoplastic therapy with allocated type I error rate 0.02) was performed. Testing was performed only if the primary endpoint was statistically significant.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value<0.0001
    CommentsP-value was based on a stratified log-rank test by PSA doubling time (< 6 months, >= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS. Threshold for significance at 0.02 level.
    MethodLog Rank
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value0.066
    Confidence Interval (2-Sided) 95%
    0.054 to 0.081
    Parameter Dispersion Type:
    Value:
    Estimation CommentsHR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with < 1 favoring Enzalutamide.
    3. Secondary Outcome
    TitleTime to First Use of New Antineoplastic Therapy
    DescriptionTime to first use of new antineoplastic therapy was defined as the time from randomization to first use of new antineoplastic for prostate cancer. Participants not starting treatment with a new antineoplastic therapy at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.
    Time FrameFrom randomization until first use of new antineoplastic therapy(until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Median (95% Confidence Interval) [months]
    39.6
    17.7
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Enzalutamide 160 mg, Placebo
    Comments To maintain the family-wise 2-sided type I error rate at 0.05, a parallel testing strategy between OS (with allocated type I error rate 0.03) and remaining key secondary endpoints (time to PSA progression and time to first use of new antineoplastic therapy with allocated type I error rate 0.02) was performed. Testing was performed only if the previous endpoint was statistically significant.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value<0.0001
    CommentsP-value was based on a stratified log-rank test by PSA doubling time (< 6 months, >= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS. Threshold for significance at 0.02 level.
    MethodLog Rank
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value0.208
    Confidence Interval (2-Sided) 95%
    0.168 to 0.258
    Parameter Dispersion Type:
    Value:
    Estimation CommentsHR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with < 1 favoring Enzalutamide.
    4. Secondary Outcome
    TitleOverall Survival
    DescriptionOverall survival (OS) was defined as the time (in months) from randomization to death from any cause. For participants who were alive at the time of the analysis data cutoff, OS time was censored at the last date the participant was known to be alive or analysis data cutoff date, whichever was earlier. Participants with no post baseline survival information were censored on the date of randomization. Analysis was based on Kaplan-Meier estimates.
    Time FrameFrom randomization until death (up to a maximum of 68.8 months)

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Median (95% Confidence Interval) [months]
    67.0
    56.3
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Enzalutamide 160 mg, Placebo
    Comments To maintain family-wise 2-sided type I error rate at 0.05,parallel testing strategy between OS(with allocated type I error rate 0.03)and remaining key secondary endpoints(time to PSA progression and time to first use of new antineoplastic therapy with allocated type I error rate 0.02)was performed.OS tested at error rate 0.05 when both time to PSA progression and time to first use of new antineoplastic therapy were significant. When either failed to show significance.OS was tested at error 0.03.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value0.0011
    CommentsP-value was based on a stratified log-rank test by PSA doubling time (< 6 months, >= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per interactive voice/web recognition system (IXRS).
    MethodLog Rank
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value0.734
    Confidence Interval (2-Sided) 95%
    0.608 to 0.885
    Parameter Dispersion Type:
    Value:
    Estimation CommentsHR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with < 1 favoring Enzalutamide.
    5. Secondary Outcome
    TitleTime to Pain Progression
    DescriptionPain was assessed using the score from the Brief Pain Inventory-Short Form (BPI-SF) question 3: "Please rate your pain by marking the box beside the number that best describes your pain at its worst in the last 24 hours." Time to this event was defined as the time from randomization to onset of pain progression, where pain progression was defined as a 2-point or more increase from baseline in the question 3 score. Participants without observed pain progression at the time of analysis were right censored at the date of last pain assessment for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.
    Time FrameFrom randomization until onset of pain progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Median (95% Confidence Interval) [months]
    18.5
    18.4
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Enzalutamide 160 mg, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value0.6534
    CommentsP-value was based on a stratified log-rank test by PSA doubling time (< 6 months, >= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS.
    MethodLog Rank
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value0.959
    Confidence Interval (2-Sided) 95%
    0.801 to 1.149
    Parameter Dispersion Type:
    Value:
    Estimation CommentsHR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with < 1 favoring Enzalutamide.
    6. Secondary Outcome
    TitleTime to First Use of Cytotoxic Chemotherapy
    DescriptionTime to first use of cytotoxic chemotherapy was defined as the time from randomization to the first use of cytotoxic chemotherapy for prostate cancer. Participants not starting treatment with a cytotoxic chemotherapy for prostate cancer at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.
    Time FrameFrom randomization up to the first use of cytotoxic chemotherapy (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Median (95% Confidence Interval) [months]
    NA
    39.7
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Enzalutamide 160 mg, Placebo
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value<0.0001
    CommentsP-value was based on a stratified log-rank test by PSA doubling time (< 6 months, >= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS.
    MethodLog Rank
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value0.378
    Confidence Interval (2-Sided) 95%
    0.282 to 0.507
    Parameter Dispersion Type:
    Value:
    Estimation CommentsHR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with < 1 favoring Enzalutamide.
    7. Secondary Outcome
    TitleChemotherapy-Free Disease Specific Survival
    DescriptionChemotherapy-free disease-specific survival was defined as the time from randomization to first use of cytotoxic chemotherapy for prostate cancer or death due to prostate cancer as assessed by the investigator. Participants not starting treatment with a cytotoxic chemotherapy or not known to have died due to prostate cancer at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.
    Time FrameFrom randomization up to first use of cytotoxic chemotherapy for prostate cancer or death due to prostate cancer (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Median (95% Confidence Interval) [months]
    39.6
    38.9
    8. Secondary Outcome
    TitleChemotherapy-Free Survival
    DescriptionChemotherapy-free survival was defined as the time from randomization to first use of cytotoxic chemotherapy for prostate cancer or death due to any cause. Participants not starting treatment with a cytotoxic chemotherapy or not known to have died at the time of analysis were censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.
    Time FrameFrom randomization up to first use of cytotoxic chemotherapy for prostate cancer or death due to any cause (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Median (95% Confidence Interval) [months]
    38.1
    34.0
    9. Secondary Outcome
    TitlePercentage of Participants With Prostate Specific Antigen (PSA) Response
    DescriptionPSA response was calculated at each visit as a decline from baseline in PSA (ng/mL) to the maximal PSA response with thresholds at 50% and 90%. Additionally, PSA response was assessed as a decline to undetectable levels, where undetectable level was defined as below the limit of quantification of the centrally assessed PSA results (the lower limit of quantification was 0.02 ng/mL). PSA response was confirmed by a second consecutive value at least 3 weeks later.
    Time FrameFrom randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Overall number of participants analyzed' = participants with baseline and at least one post-baseline PSA assessment.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Decrease from Baseline >= 50%
    76.3
    8.2%
    2.4
    0.5%
    Decrease from Baseline >= 90%
    55.9
    6%
    0.4
    0.1%
    Decrease to Undetectable Level
    9.6
    1%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Enzalutamide 160 mg, Placebo
    Comments Decrease from Baseline >= 50%
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value<0.0001
    CommentsP-value was based on a Cochran-Mantel-Haenszel mean score test stratified by PSA doubling time (<6 months, >= 6 months) and prior concurrent use of a bone targeting agent (yes, no) as per IXRS.
    MethodCochran-Mantel-Haenszel
    Comments
    Method of EstimationEstimation ParameterDifference in Response Rate
    Estimated Value73.96
    Confidence Interval (2-Sided) 95%
    70.91 to 77.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Enzalutamide 160 mg, Placebo
    Comments Decrease from Baseline >= 90%
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value<0.0001
    CommentsP-value was based on a Cochran-Mantel-Haenszel mean score test stratified by PSA doubling time (<6 months, >= 6 months) and prior concurrent use of a bone targeting agent (yes, no) as per IXRS
    MethodCochran-Mantel-Haenszel
    Comments
    Method of EstimationEstimation ParameterDifference in Response Rate
    Estimated Value55.52
    Confidence Interval (2-Sided) 95%
    52.28 to 58.76
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Enzalutamide 160 mg, Placebo
    Comments Decrease to Undetectable Level
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesisp-Value<0.0001
    CommentsP-value was based on a Cochran-Mantel-Haenszel mean score test stratified by PSA doubling time (<6 months, >= 6 months) and prior concurrent use of a bone targeting agent (yes, no) as per IXRS.
    MethodCochran-Mantel-Haenszel
    Comments
    Method of EstimationEstimation ParameterDifference in Response Rate
    Estimated Value9.65
    Confidence Interval (2-Sided) 95%
    7.75 to 11.54
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    10. Secondary Outcome
    TitleChange From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
    DescriptionThe FACT-P questionnaire is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess prostate-related symptoms. Each item was rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which ranged from 0 to 156 where higher scores represented better quality of life.
    Time FrameBaseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified timepoints.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Baseline
    119.5
    (17.75)
    120.8
    (16.73)
    Change at Week 17
    -4.0
    (14.03)
    -3.0
    (13.87)
    Change at Week 33
    -4.6
    (14.82)
    -3.5
    (13.74)
    Change at Week 49
    -3.9
    (14.70)
    -5.0
    (15.71)
    Change at Week 65
    -4.0
    (15.84)
    -5.7
    (15.04)
    Change at Week 81
    -4.1
    (15.01)
    -7.5
    (16.42)
    Change at Week 97
    -4.9
    (15.31)
    -5.9
    (15.80)
    Change at Week 113
    -5.5
    (16.07)
    -5.8
    (13.16)
    Change at Week 129
    -6.3
    (17.33)
    -8.1
    (13.99)
    Change at Week 145
    -5.5
    (18.75)
    -9.8
    (15.47)
    Change at Week 161
    -8.9
    (19.88)
    -7.0
    (10.95)
    Change at Week 177
    -4.8
    (13.19)
    -5.0
    11. Secondary Outcome
    TitleNumber of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Mobility Domain Score
    DescriptionEQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the mobility questionnaire are reported.
    Time FrameBaseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure for specified categories.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Baseline-No problem in walking
    578
    62%
    298
    63.7%
    Baseline-slight problem in walking
    183
    19.6%
    100
    21.4%
    Baseline-moderate problem in walking
    100
    10.7%
    33
    7.1%
    Baseline-severe problem in walking
    21
    2.3%
    7
    1.5%
    Baseline-unable to walk
    2
    0.2%
    1
    0.2%
    Week 17-no problem in walking
    526
    56.4%
    274
    58.5%
    Week 17-slight problem in walking
    190
    20.4%
    88
    18.8%
    Week 17-moderate problem in walking
    87
    9.3%
    50
    10.7%
    Week 17-severe problem in walking
    32
    3.4%
    6
    1.3%
    Week 17-unable to walk
    5
    0.5%
    1
    0.2%
    Week 33-no problem in walking
    431
    46.2%
    223
    47.6%
    Week 33-slight problem in walking
    162
    17.4%
    85
    18.2%
    Week 33-moderate problem in walking
    103
    11%
    24
    5.1%
    Week 33-severe problem in walking
    36
    3.9%
    10
    2.1%
    Week 33-unable to walk
    6
    0.6%
    0
    0%
    Week 49-no problem in walking
    362
    38.8%
    156
    33.3%
    Week 49-slight problem in walking
    158
    16.9%
    57
    12.2%
    Week 49-moderate problem in walking
    86
    9.2%
    27
    5.8%
    Week 49-severe problem in walking
    25
    2.7%
    8
    1.7%
    Week 49-unable to walk
    4
    0.4%
    2
    0.4%
    Week 65-no problem in walking
    319
    34.2%
    121
    25.9%
    Week 65-slight problem in walking
    109
    11.7%
    44
    9.4%
    Week 65-moderate problem in walking
    75
    8%
    22
    4.7%
    Week 65-severe problem in walking
    29
    3.1%
    6
    1.3%
    Week 65-unable to walk
    4
    0.4%
    0
    0%
    Week 81-no problem in walking
    236
    25.3%
    88
    18.8%
    Week 81-slight problem in walking
    111
    11.9%
    39
    8.3%
    Week 81-moderate problem in walking
    61
    6.5%
    15
    3.2%
    Week 81-severe problem in walking
    26
    2.8%
    4
    0.9%
    Week 81-unable to walk
    1
    0.1%
    2
    0.4%
    Week 97-no problem in walking
    189
    20.3%
    59
    12.6%
    Week 97-slight problem in walking
    94
    10.1%
    24
    5.1%
    Week 97-moderate problem in walking
    54
    5.8%
    8
    1.7%
    Week 97-severe problem in walking
    22
    2.4%
    4
    0.9%
    Week 97-unable to walk
    6
    0.6%
    0
    0%
    Week 113-no problem in walking
    140
    15%
    45
    9.6%
    Week 113-slight problem in walking
    76
    8.1%
    14
    3%
    Week 113-moderate problem in walking
    41
    4.4%
    11
    2.4%
    Week 113-severe problem in walking
    14
    1.5%
    2
    0.4%
    Week 113-unable to walk
    4
    0.4%
    1
    0.2%
    Week 129-no problem in walking
    94
    10.1%
    26
    5.6%
    Week 129-slight problem in walking
    48
    5.1%
    9
    1.9%
    Week 129-moderate problem in walking
    36
    3.9%
    5
    1.1%
    Week 129-severe problem in walking
    15
    1.6%
    1
    0.2%
    Week 129-unable to walk
    0
    0%
    0
    0%
    Week 145-no problem in walking
    56
    6%
    13
    2.8%
    Week 145-slight problem in walking
    35
    3.8%
    5
    1.1%
    Week 145-moderate problem in walking
    18
    1.9%
    2
    0.4%
    Week 145-severe problem in walking
    7
    0.8%
    1
    0.2%
    Week 145-unable to walk
    0
    0%
    0
    0%
    Week 161-no problem in walking
    22
    2.4%
    2
    0.4%
    Week 161-slight problem in walking
    7
    0.8%
    5
    1.1%
    Week 161-moderate problem in walking
    6
    0.6%
    1
    0.2%
    Week 161-severe problem in walking
    5
    0.5%
    0
    0%
    Week 161-unable to walk
    0
    0%
    0
    0%
    Week 177-no problem in walking
    3
    0.3%
    0
    0%
    Week 177-slight problem in walking
    2
    0.2%
    1
    0.2%
    Week 177-moderate problem in walking
    1
    0.1%
    0
    0%
    Week 177-severe problem in walking
    0
    0%
    0
    0%
    Week 177-unable to walk
    0
    0%
    0
    0%
    12. Secondary Outcome
    TitleNumber of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Self-Care Domain Score
    DescriptionEQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ VAS. EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the self-care questionnaire are reported.
    Time FrameBaseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure for specified categories.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Baseline:no problems washing or dressing
    805
    86.3%
    415
    88.7%
    Baseline:slight problems washing or dressing
    51
    5.5%
    23
    4.9%
    Baseline:moderate problems washing or dressing
    22
    2.4%
    1
    0.2%
    Baseline:severe problems washing or dressing
    2
    0.2%
    0
    0%
    Baseline:unable to wash or dress
    4
    0.4%
    0
    0%
    Week 17:no problems washing or dressing
    752
    80.6%
    388
    82.9%
    Week 17:slight problems washing or dressing
    60
    6.4%
    26
    5.6%
    Week 17:moderate problems washing or dressing
    21
    2.3%
    5
    1.1%
    Week 17:severe problems washing or dressing
    6
    0.6%
    0
    0%
    Week 17:unable to wash or dress
    1
    0.1%
    0
    0%
    Week 33:no problems washing or dressing
    642
    68.8%
    310
    66.2%
    Week 33:slight problems washing or dressing
    64
    6.9%
    20
    4.3%
    Week 33:moderate problems washing or dressing
    21
    2.3%
    10
    2.1%
    Week 33:severe problems washing or dressing
    4
    0.4%
    1
    0.2%
    Week 33:unable to wash or dress
    7
    0.8%
    1
    0.2%
    Week 49:no problems washing or dressing
    546
    58.5%
    230
    49.1%
    Week 49:slight problems washing or dressing
    59
    6.3%
    9
    1.9%
    Week 49:moderate problems washing or dressing
    23
    2.5%
    7
    1.5%
    Week 49:severe problems washing or dressing
    3
    0.3%
    3
    0.6%
    Week 49:unable to wash or dress
    4
    0.4%
    1
    0.2%
    Week 65:no problems washing or dressing
    453
    48.6%
    179
    38.2%
    Week 65:slight problems washing or dressing
    57
    6.1%
    11
    2.4%
    Week 65:moderate problems washing or dressing
    14
    1.5%
    3
    0.6%
    Week 65:severe problems washing or dressing
    9
    1%
    0
    0%
    Week 65:unable to wash or dress
    3
    0.3%
    0
    0%
    Week 81:no problems washing or dressing
    356
    38.2%
    132
    28.2%
    Week 81:slight problems washing or dressing
    57
    6.1%
    11
    2.4%
    Week 81:moderate problems washing or dressing
    17
    1.8%
    3
    0.6%
    Week 81:severe problems washing or dressing
    3
    0.3%
    1
    0.2%
    Week 81:unable to wash or dress
    2
    0.2%
    1
    0.2%
    Week 97:no problems washing or dressing
    292
    31.3%
    85
    18.2%
    Week 97:slight problems washing or dressing
    51
    5.5%
    8
    1.7%
    Week 97:moderate problems washing or dressing
    16
    1.7%
    2
    0.4%
    Week 97:severe problems washing or dressing
    1
    0.1%
    0
    0%
    Week 97:unable to wash or dress
    5
    0.5%
    0
    0%
    Week 113:no problems washing or dressing
    214
    22.9%
    60
    12.8%
    Week 113:slight problems washing or dressing
    46
    4.9%
    7
    1.5%
    Week 113:moderate problems washing or dressing
    11
    1.2%
    5
    1.1%
    Week 113:severe problems washing or dressing
    0
    0%
    0
    0%
    Week 113:unable to wash or dress
    4
    0.4%
    1
    0.2%
    Week 129:no problems washing or dressing
    147
    15.8%
    35
    7.5%
    Week 129:slight problems washing or dressing
    28
    3%
    5
    1.1%
    Week 129:moderate problems washing or dressing
    16
    1.7%
    1
    0.2%
    Week 129:severe problems washing or dressing
    2
    0.2%
    0
    0%
    Week 129:unable to wash or dress
    0
    0%
    0
    0%
    Week 145:no problems washing or dressing
    92
    9.9%
    15
    3.2%
    Week 145:slight problems washing or dressing
    16
    1.7%
    5
    1.1%
    Week 145:moderate problems washing or dressing
    6
    0.6%
    0
    0%
    Week 145:severe problems washing or dressing
    2
    0.2%
    0
    0%
    Week 145:unable to wash or dress
    0
    0%
    1
    0.2%
    Week 161:no problems washing or dressing
    33
    3.5%
    7
    1.5%
    Week 161:slight problems washing or dressing
    3
    0.3%
    0
    0%
    Week 161:moderate problems washing or dressing
    2
    0.2%
    1
    0.2%
    Week 161:severe problems washing or dressing
    1
    0.1%
    0
    0%
    Week 161:unable to wash or dress
    1
    0.1%
    0
    0%
    Week 177:no problems washing or dressing
    3
    0.3%
    1
    0.2%
    Week 177:slight problems washing or dressing
    3
    0.3%
    0
    0%
    Week 177:moderate problems washing or dressing
    0
    0%
    0
    0%
    Week 177:severe problems washing or dressing
    0
    0%
    0
    0%
    Week 171:unable to wash or dress
    0
    0%
    0
    0%
    13. Secondary Outcome
    TitleNumber of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Usual Activities Domain Score
    DescriptionEQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the usual activities questionnaire are reported.
    Time FrameBaseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified categories.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Baseline:no problems doing usual activities
    646
    69.2%
    356
    76.1%
    Baseline:slight problems doing usual activities
    167
    17.9%
    64
    13.7%
    Baseline:moderate problems
    56
    6%
    14
    3%
    Baseline:severe problems
    10
    1.1%
    5
    1.1%
    Baseline:unable to do usual activities
    5
    0.5%
    0
    0%
    Week 17:no problems doing usual activities
    571
    61.2%
    305
    65.2%
    Week 17:slight problems doing usual activities
    181
    19.4%
    89
    19%
    Week 17:moderate problems
    60
    6.4%
    24
    5.1%
    Week 17:severe problems
    21
    2.3%
    0
    0%
    Week 17:unable to do usual activities
    7
    0.8%
    1
    0.2%
    Week 33:no problems doing usual activities
    474
    50.8%
    249
    53.2%
    Week 33:slight problems doing usual activities
    170
    18.2%
    68
    14.5%
    Week 33:moderate problems
    68
    7.3%
    18
    3.8%
    Week 33:severe problems
    21
    2.3%
    7
    1.5%
    Week 33:unable to do usual activities
    5
    0.5%
    0
    0%
    Week 49:no problems doing usual activities
    418
    44.8%
    185
    39.5%
    Week 49:slight problems doing usual activities
    137
    14.7%
    43
    9.2%
    Week 49:moderate problems
    55
    5.9%
    14
    3%
    Week 49:severe problems
    20
    2.1%
    6
    1.3%
    Week 49:unable to do usual activities
    5
    0.5%
    2
    0.4%
    Week 65:no problems doing usual activities
    338
    36.2%
    136
    29.1%
    Week 65:slight problems doing usual activities
    123
    13.2%
    42
    9%
    Week 65:moderate problems
    60
    6.4%
    11
    2.4%
    Week 65:severe problems
    5
    0.5%
    4
    0.9%
    Week 65:unable to do usual activities
    10
    1.1%
    0
    0%
    Week 81:no problems doing usual activities
    267
    28.6%
    106
    22.6%
    Week 81:slight problems doing usual activities
    105
    11.3%
    29
    6.2%
    Week 81:moderate problems
    49
    5.3%
    7
    1.5%
    Week 81:severe problems
    10
    1.1%
    3
    0.6%
    Week 81:unable to do usual activities
    4
    0.4%
    3
    0.6%
    Week 97:no problems doing usual activities
    224
    24%
    69
    14.7%
    Week 97:slight problems doing usual activities
    90
    9.6%
    16
    3.4%
    Week 97:moderate problems
    39
    4.2%
    8
    1.7%
    Week 97:severe problems
    9
    1%
    0
    0%
    Week 97:unable to do usual activities
    3
    0.3%
    2
    0.4%
    Week 113:no problems doing usual activities
    165
    17.7%
    47
    10%
    Week 113:slight problems doing usual activities
    69
    7.4%
    16
    3.4%
    Week 113:moderate problems
    33
    3.5%
    6
    1.3%
    Week 113:severe problems
    5
    0.5%
    3
    0.6%
    Week 113:unable to do usual activities
    3
    0.3%
    1
    0.2%
    Week 129: Week :no problems doing usual activities
    108
    11.6%
    30
    6.4%
    Week 129 :slight problems doing usual activities
    56
    6%
    8
    1.7%
    Week 129:moderate problems
    26
    2.8%
    3
    0.6%
    Week 129:severe problems
    3
    0.3%
    0
    0%
    Week 129:unable to do usual activities
    0
    0%
    0
    0%
    Week 145:no problems doing usual activities
    67
    7.2%
    14
    3%
    Week 145:slight problems doing usual activities
    35
    3.8%
    4
    0.9%
    Week 145:moderate problems
    11
    1.2%
    2
    0.4%
    Week 145:severe problems
    3
    0.3%
    1
    0.2%
    Week 145:unable to do usual activities
    0
    0%
    0
    0%
    Week 161:no problems doing usual activities
    23
    2.5%
    5
    1.1%
    Week 161:slight problems doing usual activities
    9
    1%
    2
    0.4%
    Week 161:moderate problems
    5
    0.5%
    1
    0.2%
    Week 161:severe problems
    2
    0.2%
    0
    0%
    Week 161:unable to do usual activities
    1
    0.1%
    0
    0%
    Week 177:no problems doing usual activities
    3
    0.3%
    0
    0%
    Week 177:slight problems doing usual activities
    2
    0.2%
    1
    0.2%
    Week 177:moderate problems
    1
    0.1%
    0
    0%
    Week 177:severe problems
    0
    0%
    0
    0%
    Week 177:unable to do usual activities
    0
    0%
    0
    0%
    14. Secondary Outcome
    TitleNumber of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Pain/Discomfort Domain Score
    DescriptionEQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the pain/discomfort questionnaire are reported.
    Time FrameBaseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified categories.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Baseline:no pain or discomfort
    546
    58.5%
    292
    62.4%
    Baseline:slight pain or discomfort
    240
    25.7%
    117
    25%
    Baseline:moderate pain or discomfort
    86
    9.2%
    25
    5.3%
    Baseline:severe pain or discomfort
    10
    1.1%
    4
    0.9%
    Baseline:extreme pain or discomfort
    2
    0.2%
    1
    0.2%
    Week 17:no pain or discomfort
    464
    49.7%
    248
    53%
    Week 17:slight pain or discomfort
    269
    28.8%
    128
    27.4%
    Week 17: moderate pain or discomfort
    92
    9.9%
    41
    8.8%
    Week 17:severe pain or discomfort
    13
    1.4%
    2
    0.4%
    Week 17:extreme pain or discomfort
    2
    0.2%
    0
    0%
    Week 33:no pain or discomfort
    405
    43.4%
    204
    43.6%
    Week 33:slight pain or discomfort
    237
    25.4%
    110
    23.5%
    Week 33:moderate pain or discomfort
    79
    8.5%
    21
    4.5%
    Week 33:severe pain or discomfort
    16
    1.7%
    7
    1.5%
    Week 33:extreme pain or discomfort
    1
    0.1%
    0
    0%
    Week 49:no pain or discomfort
    340
    36.4%
    134
    28.6%
    Week 49:slight pain or discomfort
    209
    22.4%
    82
    17.5%
    Week 49:moderate pain or discomfort
    75
    8%
    32
    6.8%
    Week 49:severe pain or discomfort
    10
    1.1%
    1
    0.2%
    Week 49:extreme pain or discomfort
    1
    0.1%
    1
    0.2%
    Week 65:no pain or discomfort
    298
    31.9%
    102
    21.8%
    Week 65:slight pain or discomfort
    162
    17.4%
    72
    15.4%
    Week 65:moderate pain or discomfort
    61
    6.5%
    15
    3.2%
    Week 65:severe pain or discomfort
    11
    1.2%
    3
    0.6%
    Week 65:extreme pain or discomfort
    4
    0.4%
    1
    0.2%
    Week 81:no pain or discomfort
    231
    24.8%
    86
    18.4%
    Week 81:slight pain or discomfort
    133
    14.3%
    45
    9.6%
    Week 81:moderate pain or discomfort
    61
    6.5%
    13
    2.8%
    Week 81 :severe pain or discomfort
    10
    1.1%
    2
    0.4%
    Week 81:extreme pain or discomfort
    0
    0%
    2
    0.4%
    Week 97:no pain or discomfort
    202
    21.7%
    58
    12.4%
    Week 97:slight pain or discomfort
    115
    12.3%
    28
    6%
    Week 97:moderate pain or discomfort
    43
    4.6%
    7
    1.5%
    Week 97:severe pain or discomfort
    5
    0.5%
    2
    0.4%
    Week 97:extreme pain or discomfort
    0
    0%
    0
    0%
    Week 113:no pain or discomfort
    152
    16.3%
    47
    10%
    Week 113:slight pain or discomfort
    80
    8.6%
    19
    4.1%
    Week 113:moderate pain or discomfort
    37
    4%
    5
    1.1%
    Week 113:severe pain or discomfort
    6
    0.6%
    2
    0.4%
    Week 113:extreme pain or discomfort
    0
    0%
    0
    0%
    Week 129:no pain or discomfort
    108
    11.6%
    27
    5.8%
    Week 129:slight pain or discomfort
    55
    5.9%
    11
    2.4%
    Week 129:moderate pain or discomfort
    28
    3%
    3
    0.6%
    Week 129:severe pain or discomfort
    2
    0.2%
    0
    0%
    Week 129:extreme pain or discomfort
    0
    0%
    0
    0%
    Week 145:no pain or discomfort
    62
    6.6%
    12
    2.6%
    Week 145:slight pain or discomfort
    38
    4.1%
    8
    1.7%
    Week 145:moderate pain or discomfort
    15
    1.6%
    1
    0.2%
    Week 145:severe pain or discomfort
    1
    0.1%
    0
    0%
    Week 145:extreme pain or discomfort
    0
    0%
    0
    0%
    Week 161:no pain or discomfort
    24
    2.6%
    2
    0.4%
    Week 161:slight pain or discomfort
    8
    0.9%
    5
    1.1%
    Week 161:moderate pain or discomfort
    5
    0.5%
    1
    0.2%
    Week 161:severe pain or discomfort
    3
    0.3%
    0
    0%
    Week 161:extreme pain or discomfort
    0
    0%
    0
    0%
    Week 177:no pain or discomfort
    3
    0.3%
    0
    0%
    Week 177:slight pain or discomfort
    1
    0.1%
    1
    0.2%
    Week 177:moderate pain or discomfort
    2
    0.2%
    0
    0%
    Week 177:severe pain or discomfort
    0
    0%
    0
    0%
    Week 177:extreme pain or discomfort
    0
    0%
    0
    0%
    15. Secondary Outcome
    TitleNumber of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Anxiety/ Depression Domain Score
    DescriptionEQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the anxiety/depression questionnaire are reported.
    Time FrameBaseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified categories.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Baseline:not anxious or depressed
    595
    63.8%
    310
    66.2%
    Baseline:slightly anxious or depressed
    231
    24.8%
    100
    21.4%
    Baseline:moderately anxious or depressed
    51
    5.5%
    24
    5.1%
    Baseline:severely anxious or depressed
    6
    0.6%
    5
    1.1%
    Baseline:extremely anxious or depressed
    1
    0.1%
    0
    0%
    Week 17:not anxious or depressed
    517
    55.4%
    265
    56.6%
    Week 17:slightly anxious or depressed
    251
    26.9%
    119
    25.4%
    Week 17:moderately anxious or depressed
    62
    6.6%
    31
    6.6%
    Week 17:severely anxious or depressed
    7
    0.8%
    4
    0.9%
    Week 17:extremely anxious or depressed
    3
    0.3%
    0
    0%
    Week 33:not anxious or depressed
    458
    49.1%
    223
    47.6%
    Week 33:slightly anxious or depressed
    208
    22.3%
    89
    19%
    Week 33:moderately anxious or depressed
    61
    6.5%
    23
    4.9%
    Week 33:severely anxious or depressed
    9
    1%
    5
    1.1%
    Week 33:extremely anxious or depressed
    2
    0.2%
    2
    0.4%
    Week 49:not anxious or depressed
    410
    43.9%
    155
    33.1%
    Week 49:slightly anxious or depressed
    172
    18.4%
    72
    15.4%
    Week 49:moderately anxious or depressed
    41
    4.4%
    20
    4.3%
    Week 49:severely anxious or depressed
    8
    0.9%
    2
    0.4%
    Week 49:extremely anxious or depressed
    4
    0.4%
    1
    0.2%
    Week 65:not anxious or depressed
    336
    36%
    128
    27.4%
    Week 65:slightly anxious or depressed
    149
    16%
    56
    12%
    Week 65:moderately anxious or depressed
    43
    4.6%
    8
    1.7%
    Week 65:severely anxious or depressed
    8
    0.9%
    1
    0.2%
    Week 65:extremely anxious or depressed
    0
    0%
    0
    0%
    Week 81:not anxious or depressed
    288
    30.9%
    86
    18.4%
    Week 81:slightly anxious or depressed
    106
    11.4%
    48
    10.3%
    Week 81:moderately anxious or depressed
    34
    3.6%
    9
    1.9%
    Week 81:severely anxious or depressed
    7
    0.8%
    3
    0.6%
    Week 81:extremely anxious or depressed
    0
    0%
    2
    0.4%
    Week 97:not anxious or depressed
    220
    23.6%
    61
    13%
    Week 97:slightly anxious or depressed
    114
    12.2%
    27
    5.8%
    Week 97:moderately anxious or depressed
    26
    2.8%
    6
    1.3%
    Week 97:severely anxious or depressed
    4
    0.4%
    0
    0%
    Week 97:extremely anxious or depressed
    1
    0.1%
    1
    0.2%
    Week 113:not anxious or depressed
    167
    17.9%
    43
    9.2%
    Week 113:slightly anxious or depressed
    87
    9.3%
    27
    5.8%
    Week 113:moderately anxious or depressed
    18
    1.9%
    3
    0.6%
    Week 113:severely anxious or depressed
    3
    0.3%
    0
    0%
    Week 113:extremely anxious or depressed
    0
    0%
    0
    0%
    Week 129:not anxious or depressed
    121
    13%
    28
    6%
    Week 129:slightly anxious or depressed
    51
    5.5%
    10
    2.1%
    Week 129:moderately anxious or depressed
    18
    1.9%
    2
    0.4%
    Week 129:severely anxious or depressed
    2
    0.2%
    1
    0.2%
    Week 129:extremely anxious or depressed
    1
    0.1%
    0
    0%
    Week 145:not anxious or depressed
    73
    7.8%
    12
    2.6%
    Week 145:slightly anxious or depressed
    30
    3.2%
    8
    1.7%
    Week 145:moderately anxious or depressed
    10
    1.1%
    1
    0.2%
    Week 145:severely anxious or depressed
    2
    0.2%
    0
    0%
    Week 145:extremely anxious or depressed
    1
    0.1%
    0
    0%
    Week 161:not anxious or depressed
    23
    2.5%
    3
    0.6%
    Week 161:slightly anxious or depressed
    16
    1.7%
    4
    0.9%
    Week 161:moderately anxious or depressed
    0
    0%
    1
    0.2%
    Week 161:severely anxious or depressed
    0
    0%
    0
    0%
    Week 161:extremely anxious or depressed
    1
    0.1%
    0
    0%
    Week 177:not anxious or depressed
    2
    0.2%
    1
    0.2%
    Week 177:slightly anxious or depressed
    2
    0.2%
    0
    0%
    Week 177:moderately anxious or depressed
    2
    0.2%
    0
    0%
    Week 177:severely anxious or depressed
    0
    0%
    0
    0%
    Week 177:extremely anxious or depressed
    0
    0%
    0
    0%
    16. Secondary Outcome
    TitleEuropean Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Status Visual Analog Score (VAS)
    DescriptionEQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ VAS. EQ-5D-5L-VAS records participant's self-rated health on a vertical VAS that allows them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable), higher scores indicating a better health state.
    Time FrameBaseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified timepoints.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Baseline
    76.2
    (16.92)
    77.5
    (15.97)
    Week 17
    74.7
    (17.19)
    74.9
    (16.79)
    Week 33
    74.6
    (16.69)
    74.0
    (17.51)
    Week 49
    74.7
    (18.02)
    73.7
    (18.28)
    Week 65
    74.5
    (17.79)
    73.0
    (17.11)
    Week 81
    75.5
    (17.06)
    73.3
    (16.82)
    Week 97
    74.4
    (17.39)
    75.2
    (17.88)
    Week 113
    73.6
    (18.05)
    74.7
    (15.06)
    Week 129
    72.8
    (18.25)
    77.1
    (12.83)
    Week 145
    75.3
    (17.02)
    74.2
    (18.13)
    Week 161
    74.6
    (21.28)
    73.8
    (17.60)
    Week 177
    74.5
    (19.31)
    69.0
    17. Secondary Outcome
    TitleNumber of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 31
    DescriptionThe EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 31 are reported. Question 31 was following: "Have you had to urinate frequently during the day?"
    Time FrameBaseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified categories.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Baseline: not at all
    285
    30.5%
    162
    34.6%
    Baseline: a little
    348
    37.3%
    160
    34.2%
    Baseline: quite a bit
    207
    22.2%
    92
    19.7%
    Baseline: very much
    44
    4.7%
    25
    5.3%
    Baseline: not answered
    0
    0%
    0
    0%
    Week 17: not at all
    275
    29.5%
    134
    28.6%
    Week 17: a little
    324
    34.7%
    168
    35.9%
    Week 17: quite a bit
    194
    20.8%
    90
    19.2%
    Week 17: very much
    46
    4.9%
    27
    5.8%
    Week 17: not answered
    0
    0%
    0
    0%
    Week 33: not at all
    236
    25.3%
    105
    22.4%
    Week 33: a little
    285
    30.5%
    145
    31%
    Week 33: quite a bit
    176
    18.9%
    70
    15%
    Week 33: very much
    40
    4.3%
    21
    4.5%
    Week 33: not answered
    0
    0%
    0
    0%
    Week 49: not at all
    200
    21.4%
    82
    17.5%
    Week 49: a little
    260
    27.9%
    92
    19.7%
    Week 49: quite a bit
    148
    15.9%
    67
    14.3%
    Week 49: very much
    27
    2.9%
    9
    1.9%
    Week 49: not answered
    0
    0%
    0
    0%
    Week 65: not at all
    172
    18.4%
    54
    11.5%
    Week 65: a little
    209
    22.4%
    79
    16.9%
    Week 65: quite a bit
    125
    13.4%
    48
    10.3%
    Week 65: very much
    30
    3.2%
    12
    2.6%
    Week 65: not answered
    0
    0%
    0
    0%
    Week 81: not at all
    141
    15.1%
    46
    9.8%
    Week 81: a little
    181
    19.4%
    60
    12.8%
    Week 81: quite a bit
    92
    9.9%
    31
    6.6%
    Week 81: very much
    20
    2.1%
    11
    2.4%
    Week 81: not answered
    0
    0%
    0
    0%
    Week 97: not at all
    118
    12.6%
    33
    7.1%
    Week 97: a little
    146
    15.6%
    40
    8.5%
    Week 97: quite a bit
    80
    8.6%
    19
    4.1%
    Week 97: very much
    21
    2.3%
    3
    0.6%
    Week 97: not answered
    0
    0%
    0
    0%
    Week 113: not at all
    101
    10.8%
    17
    3.6%
    Week 113: a little
    112
    12%
    40
    8.5%
    Week 113: quite a bit
    46
    4.9%
    14
    3%
    Week 113: very much
    16
    1.7%
    2
    0.4%
    Week 113: not answered
    0
    0%
    0
    0%
    Week 129: not at all
    70
    7.5%
    11
    2.4%
    Week 129: a little
    79
    8.5%
    16
    3.4%
    Week 129: quite a bit
    39
    4.2%
    10
    2.1%
    Week 129: very much
    4
    0.4%
    4
    0.9%
    Week 129: not answered
    0
    0%
    0
    0%
    Week 145: not at all
    42
    4.5%
    2
    0.4%
    Week 145: a little
    51
    5.5%
    14
    3%
    Week 145: quite a bit
    20
    2.1%
    4
    0.9%
    Week 145: very much
    3
    0.3%
    1
    0.2%
    Week 145: not answered
    0
    0%
    0
    0%
    Week 161: not at all
    9
    1%
    2
    0.4%
    Week 161: a little
    20
    2.1%
    4
    0.9%
    Week 161: quite a bit
    7
    0.8%
    1
    0.2%
    Week 161: very much
    4
    0.4%
    1
    0.2%
    Week 161: not answered
    0
    0%
    0
    0%
    Week 177: not at all
    0
    0%
    0
    0%
    Week 177: a little
    4
    0.4%
    1
    0.2%
    Week 177: quite a bit
    2
    0.2%
    0
    0%
    Week 177: very much
    0
    0%
    0
    0%
    Week 177: not answered
    0
    0%
    0
    0%
    18. Secondary Outcome
    TitleNumber of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 32
    DescriptionThe EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 32 are reported. Question 32 was following: "Have you had to urinate frequently at night?"
    Time FrameBaseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified categories.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Baseline: not at all
    193
    20.7%
    108
    23.1%
    Baseline: a little
    423
    45.3%
    195
    41.7%
    Baseline: quite a bit
    200
    21.4%
    103
    22%
    Baseline: very much
    68
    7.3%
    33
    7.1%
    Baseline: not answered
    0
    0%
    0
    0%
    Week 17: not at all
    194
    20.8%
    88
    18.8%
    Week 17: a little
    407
    43.6%
    199
    42.5%
    Week 17: quite a bit
    184
    19.7%
    98
    20.9%
    Week 17: very much
    54
    5.8%
    34
    7.3%
    Week 17: not answered
    0
    0%
    0
    0%
    Week 33: not at all
    173
    18.5%
    83
    17.7%
    Week 33: a little
    351
    37.6%
    161
    34.4%
    Week 33: quite a bit
    169
    18.1%
    69
    14.7%
    Week 33: very much
    44
    4.7%
    28
    6%
    Week 33: not answered
    0
    0%
    0
    0%
    Week 49: not at all
    148
    15.9%
    59
    12.6%
    Week 49: a little
    313
    33.5%
    116
    24.8%
    Week 49: quite a bit
    141
    15.1%
    59
    12.6%
    Week 49: very much
    33
    3.5%
    16
    3.4%
    Week 49: not answered
    0
    0%
    0
    0%
    Week 65: not at all
    118
    12.6%
    41
    8.8%
    Week 65: a little
    266
    28.5%
    89
    19%
    Week 65: quite a bit
    111
    11.9%
    48
    10.3%
    Week 65: very much
    41
    4.4%
    15
    3.2%
    Week 65: not answered
    0
    0%
    0
    0%
    Week 81: not at all
    91
    9.8%
    38
    8.1%
    Week 81: a little
    231
    24.8%
    60
    12.8%
    Week 81: quite a bit
    89
    9.5%
    38
    8.1%
    Week 81: very much
    23
    2.5%
    12
    2.6%
    Week 81: not answered
    0
    0%
    0
    0%
    Week 97: not at all
    88
    9.4%
    19
    4.1%
    Week 97: a little
    169
    18.1%
    53
    11.3%
    Week 97: quite a bit
    82
    8.8%
    19
    4.1%
    Week 97: very much
    26
    2.8%
    4
    0.9%
    Week 97: not answered
    0
    0%
    0
    0%
    Week 113: not at all
    67
    7.2%
    16
    3.4%
    Week 113: a little
    137
    14.7%
    32
    6.8%
    Week 113: quite a bit
    54
    5.8%
    23
    4.9%
    Week 113: very much
    17
    1.8%
    2
    0.4%
    Week 113: not answered
    0
    0%
    0
    0%
    Week 129: not at all
    50
    5.4%
    9
    1.9%
    Week 129: a little
    97
    10.4%
    18
    3.8%
    Week 129: quite a bit
    37
    4%
    10
    2.1%
    Week 129: very much
    8
    0.9%
    4
    0.9%
    Week 129: not answered
    0
    0%
    0
    0%
    Week 145: not at all
    31
    3.3%
    2
    0.4%
    Week 145: a little
    59
    6.3%
    14
    3%
    Week 145: quite a bit
    24
    2.6%
    5
    1.1%
    Week 145: very much
    2
    0.2%
    0
    0%
    Week 145: not answered
    0
    0%
    0
    0%
    Week 161: not at all
    9
    1%
    0
    0%
    Week 161: a little
    23
    2.5%
    7
    1.5%
    Week 161: quite a bit
    5
    0.5%
    0
    0%
    Week 161: very much
    3
    0.3%
    1
    0.2%
    Week 161: not answered
    0
    0%
    0
    0%
    Week 177: not at all
    2
    0.2%
    0
    0%
    Week 177: a little
    2
    0.2%
    1
    0.2%
    Week 177: quite a bit
    2
    0.2%
    0
    0%
    Week 177: very much
    0
    0%
    0
    0%
    Week 177: not answered
    0
    0%
    0
    0%
    19. Secondary Outcome
    TitleNumber of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 33
    DescriptionThe EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 33 are reported. Question 33 was following: "When you felt the urge to pass urine, did you have to hurry to get to the toilet?"
    Time FrameBaseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified categories.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Baseline: not at all
    406
    43.5%
    197
    42.1%
    Baseline: a little
    266
    28.5%
    147
    31.4%
    Baseline: quite a bit
    150
    16.1%
    70
    15%
    Baseline: very much
    62
    6.6%
    25
    5.3%
    Baseline: not answered
    0
    0%
    0
    0%
    Week 17: not at all
    350
    37.5%
    191
    40.8%
    Week 17: a little
    297
    31.8%
    150
    32.1%
    Week 17: quite a bit
    127
    13.6%
    55
    11.8%
    Week 17: very much
    65
    7%
    23
    4.9%
    Week 17: not answered
    0
    0%
    0
    0%
    Week 33: not at all
    279
    29.9%
    147
    31.4%
    Week 33: a little
    278
    29.8%
    126
    26.9%
    Week 33: quite a bit
    126
    13.5%
    48
    10.3%
    Week 33: very much
    54
    5.8%
    20
    4.3%
    Week 33: not answered
    0
    0%
    0
    0%
    Week 49: not at all
    272
    29.2%
    100
    21.4%
    Week 49: a little
    222
    23.8%
    95
    20.3%
    Week 49: quite a bit
    96
    10.3%
    38
    8.1%
    Week 49: very much
    45
    4.8%
    17
    3.6%
    Week 49: not answered
    0
    0%
    0
    0%
    Week 65: not at all
    213
    22.8%
    76
    16.2%
    Week 65: a little
    213
    22.8%
    72
    15.4%
    Week 65: quite a bit
    71
    7.6%
    31
    6.6%
    Week 65: very much
    39
    4.2%
    14
    3%
    Week 65: not answered
    0
    0%
    0
    0%
    Week 81: not at all
    181
    19.4%
    63
    13.5%
    Week 81: a little
    157
    16.8%
    52
    11.1%
    Week 81: quite a bit
    69
    7.4%
    27
    5.8%
    Week 81: very much
    27
    2.9%
    6
    1.3%
    Week 81: not answered
    0
    0%
    0
    0%
    Week 97: not at all
    146
    15.6%
    40
    8.5%
    Week 97: a little
    131
    14%
    40
    8.5%
    Week 97: quite a bit
    59
    6.3%
    12
    2.6%
    Week 97: very much
    29
    3.1%
    3
    0.6%
    Week 97: not answered
    0
    0%
    0
    0%
    Week 113: not at all
    114
    12.2%
    29
    6.2%
    Week 113: a little
    106
    11.4%
    34
    7.3%
    Week 113: quite a bit
    40
    4.3%
    9
    1.9%
    Week 113: very much
    15
    1.6%
    1
    0.2%
    Week 113: not answered
    0
    0%
    0
    0%
    Week 129: not at all
    86
    9.2%
    10
    2.1%
    Week 129: a little
    72
    7.7%
    21
    4.5%
    Week 129: quite a bit
    26
    2.8%
    6
    1.3%
    Week 129: very much
    8
    0.9%
    4
    0.9%
    Week 129: not answered
    0
    0%
    0
    0%
    Week 145: not at all
    51
    5.5%
    5
    1.1%
    Week 145: a little
    39
    4.2%
    12
    2.6%
    Week 145: quite a bit
    21
    2.3%
    4
    0.9%
    Week 145: very much
    5
    0.5%
    0
    0%
    Week 145: not answered
    0
    0%
    0
    0%
    Week 161: not at all
    17
    1.8%
    0
    0%
    Week 161: a little
    19
    2%
    5
    1.1%
    Week 161: quite a bit
    3
    0.3%
    3
    0.6%
    Week 161: very much
    1
    0.1%
    0
    0%
    Week 161: not answered
    0
    0%
    0
    0%
    Week 177: not at all
    2
    0.2%
    0
    0%
    Week 177: a little
    1
    0.1%
    1
    0.2%
    Week 177: quite a bit
    3
    0.3%
    0
    0%
    Week 177: very much
    0
    0%
    0
    0%
    Week 177: not answered
    0
    0%
    0
    0%
    20. Secondary Outcome
    TitleNumber of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 34
    DescriptionThe EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 34 are reported. Question 34 was following: "Was it difficult for you to get enough sleep, because you needed to get up frequently at night to urinate?"
    Time FrameBaseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified categories.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Baseline: not at all
    479
    51.3%
    235
    50.2%
    Baseline: a little
    273
    29.3%
    146
    31.2%
    Baseline: quite a bit
    93
    10%
    40
    8.5%
    Baseline: very much
    39
    4.2%
    18
    3.8%
    Baseline: not answered
    0
    0%
    0
    0%
    Week 17: not at all
    437
    46.8%
    214
    45.7%
    Week 17: a little
    295
    31.6%
    144
    30.8%
    Week 17: quite a bit
    75
    8%
    45
    9.6%
    Week 17: very much
    32
    3.4%
    16
    3.4%
    Week 17: not answered
    0
    0%
    0
    0%
    Week 33: not at all
    392
    42%
    180
    38.5%
    Week 33: a little
    246
    26.4%
    112
    23.9%
    Week 33: quite a bit
    75
    8%
    33
    7.1%
    Week 33: very much
    24
    2.6%
    16
    3.4%
    Week 33: not answered
    0
    0%
    0
    0%
    Week 49: not at all
    340
    36.4%
    119
    25.4%
    Week 49: a little
    211
    22.6%
    94
    20.1%
    Week 49: quite a bit
    65
    7%
    28
    6%
    Week 49: very much
    19
    2%
    9
    1.9%
    Week 49: not answered
    0
    0%
    0
    0%
    Week 65: not at all
    286
    30.7%
    92
    19.7%
    Week 65: a little
    183
    19.6%
    67
    14.3%
    Week 65: quite a bit
    47
    5%
    29
    6.2%
    Week 65: very much
    20
    2.1%
    5
    1.1%
    Week 65: not answered
    0
    0%
    0
    0%
    Week 81: not at all
    221
    23.7%
    70
    15%
    Week 81: a little
    165
    17.7%
    55
    11.8%
    Week 81: quite a bit
    37
    4%
    18
    3.8%
    Week 81: very much
    11
    1.2%
    5
    1.1%
    Week 81: not answered
    0
    0%
    0
    0%
    Week 97: not at all
    185
    19.8%
    47
    10%
    Week 97: a little
    122
    13.1%
    33
    7.1%
    Week 97: quite a bit
    43
    4.6%
    14
    3%
    Week 97: very much
    15
    1.6%
    1
    0.2%
    Week 97: not answered
    0
    0%
    0
    0%
    Week 113: not at all
    135
    14.5%
    31
    6.6%
    Week 113: a little
    102
    10.9%
    33
    7.1%
    Week 113: quite a bit
    29
    3.1%
    7
    1.5%
    Week 113: very much
    9
    1%
    2
    0.4%
    Week 113: not answered
    0
    0%
    0
    0%
    Week 129: not at all
    103
    11%
    13
    2.8%
    Week 129: a little
    67
    7.2%
    23
    4.9%
    Week 129: quite a bit
    19
    2%
    4
    0.9%
    Week 129: very much
    3
    0.3%
    1
    0.2%
    Week 129: not answered
    0
    0%
    0
    0%
    Week 145: not at all
    59
    6.3%
    9
    1.9%
    Week 145: a little
    44
    4.7%
    10
    2.1%
    Week 145: quite a bit
    11
    1.2%
    1
    0.2%
    Week 145: very much
    2
    0.2%
    1
    0.2%
    Week 145: not answered
    0
    0%
    0
    0%
    Week 161: not at all
    21
    2.3%
    2
    0.4%
    Week 161: a little
    16
    1.7%
    5
    1.1%
    Week 161: quite a bit
    3
    0.3%
    0
    0%
    Week 161: very much
    0
    0%
    1
    0.2%
    Week 161: not answered
    0
    0%
    0
    0%
    Week 177: not at all
    3
    0.3%
    0
    0%
    Week 177: a little
    1
    0.1%
    1
    0.2%
    Week 177: quite a bit
    2
    0.2%
    0
    0%
    Week 177: very much
    0
    0%
    0
    0%
    Week 177: not answered
    0
    0%
    0
    0%
    21. Secondary Outcome
    TitleNumber of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 35
    DescriptionThe EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 35 are reported. Question 35 was following: "Have you had difficulty going out of the house because you needed to be close to a toilet?"
    Time FrameBaseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified categories.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Baseline: not at all
    646
    69.2%
    330
    70.5%
    Baseline: a little
    177
    19%
    84
    17.9%
    Baseline: quite a bit
    45
    4.8%
    18
    3.8%
    Baseline: very much
    16
    1.7%
    7
    1.5%
    Baseline: not answered
    0
    0%
    0
    0%
    Week 17: not at all
    604
    64.7%
    295
    63%
    Week 17: a little
    174
    18.6%
    100
    21.4%
    Week 17: quite a bit
    46
    4.9%
    15
    3.2%
    Week 17: very much
    15
    1.6%
    9
    1.9%
    Week 17: not answered
    0
    0%
    0
    0%
    Week 33: not at all
    501
    53.7%
    242
    51.7%
    Week 33: a little
    171
    18.3%
    74
    15.8%
    Week 33: quite a bit
    50
    5.4%
    20
    4.3%
    Week 33: very much
    15
    1.6%
    5
    1.1%
    Week 33: not answered
    0
    0%
    0
    0%
    Week 49: not at all
    436
    46.7%
    174
    37.2%
    Week 49: a little
    153
    16.4%
    53
    11.3%
    Week 49: quite a bit
    38
    4.1%
    20
    4.3%
    Week 49: very much
    8
    0.9%
    3
    0.6%
    Week 49: not answered
    0
    0%
    0
    0%
    Week 65: not at all
    369
    39.5%
    132
    28.2%
    Week 65: a little
    125
    13.4%
    50
    10.7%
    Week 65: quite a bit
    28
    3%
    9
    1.9%
    Week 65: very much
    14
    1.5%
    2
    0.4%
    Week 65: not answered
    0
    0%
    0
    0%
    Week 81: not at all
    308
    33%
    105
    22.4%
    Week 81: a little
    94
    10.1%
    35
    7.5%
    Week 81: quite a bit
    23
    2.5%
    8
    1.7%
    Week 81: very much
    9
    1%
    0
    0%
    Week 81: not answered
    0
    0%
    0
    0%
    Week 97: not at all
    241
    25.8%
    67
    14.3%
    Week 97: a little
    91
    9.8%
    21
    4.5%
    Week 97: quite a bit
    26
    2.8%
    6
    1.3%
    Week 97: very much
    7
    0.8%
    1
    0.2%
    Week 97: not answered
    0
    0%
    0
    0%
    Week 113: not at all
    180
    19.3%
    47
    10%
    Week 113: a little
    70
    7.5%
    21
    4.5%
    Week 113: quite a bit
    18
    1.9%
    5
    1.1%
    Week 113: very much
    7
    0.8%
    0
    0%
    Week 113: not answered
    0
    0%
    0
    0%
    Week 129: not at all
    131
    14%
    26
    5.6%
    Week 129: a little
    48
    5.1%
    13
    2.8%
    Week 129: quite a bit
    8
    0.9%
    1
    0.2%
    Week 129: very much
    5
    0.5%
    1
    0.2%
    Week 129: not answered
    0
    0%
    0
    0%
    Week 145: not at all
    74
    7.9%
    13
    2.8%
    Week 145: a little
    36
    3.9%
    6
    1.3%
    Week 145: quite a bit
    6
    0.6%
    0
    0%
    Week 145: very much
    0
    0%
    2
    0.4%
    Week 145: not answered
    0
    0%
    0
    0%
    Week 161: not at all
    24
    2.6%
    4
    0.9%
    Week 161: a little
    13
    1.4%
    4
    0.9%
    Week 161: quite a bit
    3
    0.3%
    0
    0%
    Week 161: very much
    0
    0%
    0
    0%
    Week 161: not answered
    0
    0%
    0
    0%
    Week 177: not at all
    3
    0.3%
    0
    0%
    Week 177: a little
    3
    0.3%
    1
    0.2%
    Week 177: quite a bit
    0
    0%
    0
    0%
    Week 177: very much
    0
    0%
    0
    0%
    Week 177: not answered
    0
    0%
    0
    0%
    22. Secondary Outcome
    TitleNumber of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 36
    DescriptionThe EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 36 are reported. Question 36 was following: "Have you had any unintentional release (leakage) of urine?"
    Time FrameBaseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified categories.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Baseline: not at all
    550
    58.9%
    283
    60.5%
    Baseline: a little
    273
    29.3%
    124
    26.5%
    Baseline: quite a bit
    36
    3.9%
    20
    4.3%
    Baseline: very much
    25
    2.7%
    12
    2.6%
    Baseline: not answered
    0
    0%
    0
    0%
    Week 17: not at all
    511
    54.8%
    255
    54.5%
    Week 17: a little
    264
    28.3%
    126
    26.9%
    Week 17: quite a bit
    39
    4.2%
    27
    5.8%
    Week 17: very much
    25
    2.7%
    11
    2.4%
    Week 17: not answered
    0
    0%
    0
    0%
    Week 33: not at all
    428
    45.9%
    208
    44.4%
    Week 33: a little
    246
    26.4%
    104
    22.2%
    Week 33: quite a bit
    34
    3.6%
    19
    4.1%
    Week 33: very much
    29
    3.1%
    10
    2.1%
    Week 33: not answered
    0
    0%
    0
    0%
    Week 49: not at all
    369
    39.5%
    146
    31.2%
    Week 49: a little
    209
    22.4%
    78
    16.7%
    Week 49: quite a bit
    41
    4.4%
    22
    4.7%
    Week 49: very much
    16
    1.7%
    4
    0.9%
    Week 49: not answered
    0
    0%
    0
    0%
    Week 65: not at all
    307
    32.9%
    115
    24.6%
    Week 65: a little
    170
    18.2%
    66
    14.1%
    Week 65: quite a bit
    47
    5%
    8
    1.7%
    Week 65: very much
    12
    1.3%
    4
    0.9%
    Week 65: not answered
    0
    0%
    0
    0%
    Week 81: not at all
    248
    26.6%
    93
    19.9%
    Week 81: a little
    158
    16.9%
    41
    8.8%
    Week 81: quite a bit
    23
    2.5%
    11
    2.4%
    Week 81: very much
    5
    0.5%
    3
    0.6%
    Week 81: not answered
    0
    0%
    0
    0%
    Week 97: not at all
    195
    20.9%
    55
    11.8%
    Week 97: a little
    134
    14.4%
    33
    7.1%
    Week 97: quite a bit
    25
    2.7%
    7
    1.5%
    Week 97: very much
    11
    1.2%
    0
    0%
    Week 97: not answered
    0
    0%
    0
    0%
    Week 113: not at all
    160
    17.1%
    42
    9%
    Week 113: a little
    91
    9.8%
    28
    6%
    Week 113: quite a bit
    17
    1.8%
    3
    0.6%
    Week 113: very much
    7
    0.8%
    0
    0%
    Week 113: not answered
    0
    0%
    0
    0%
    Week 129: not at all
    109
    11.7%
    22
    4.7%
    Week 129: a little
    68
    7.3%
    13
    2.8%
    Week 129: quite a bit
    13
    1.4%
    5
    1.1%
    Week 129: very much
    2
    0.2%
    1
    0.2%
    Week 129: not answered
    0
    0%
    0
    0%
    Week 145: not at all
    58
    6.2%
    9
    1.9%
    Week 145: a little
    45
    4.8%
    11
    2.4%
    Week 145: quite a bit
    10
    1.1%
    0
    0%
    Week 145: very much
    3
    0.3%
    1
    0.2%
    Week 145: not answered
    0
    0%
    0
    0%
    Week 161: not at all
    18
    1.9%
    3
    0.6%
    Week 161: a little
    21
    2.3%
    4
    0.9%
    Week 161: quite a bit
    0
    0%
    1
    0.2%
    Week 161: very much
    1
    0.1%
    0
    0%
    Week 161: not answered
    0
    0%
    0
    0%
    Week 177: not at all
    1
    0.1%
    0
    0%
    Week 177: a little
    3
    0.3%
    1
    0.2%
    Week 177: quite a bit
    1
    0.1%
    0
    0%
    Week 177: very much
    1
    0.1%
    0
    0%
    Week 177: not answered
    0
    0%
    0
    0%
    23. Secondary Outcome
    TitleNumber of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 37
    DescriptionThe EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 37 are reported. Question 37 was following: "Did you have pain when you urinated?"
    Time FrameBaseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified categories.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Baseline: not at all
    775
    83.1%
    380
    81.2%
    Baseline: a little
    92
    9.9%
    47
    10%
    Baseline: quite a bit
    10
    1.1%
    8
    1.7%
    Baseline: very much
    7
    0.8%
    4
    0.9%
    Baseline: not answered
    0
    0%
    0
    0%
    Week 17: not at all
    762
    81.7%
    351
    75%
    Week 17: a little
    65
    7%
    58
    12.4%
    Week 17: quite a bit
    12
    1.3%
    8
    1.7%
    Week 17: very much
    0
    0%
    2
    0.4%
    Week 17: not answered
    0
    0%
    0
    0%
    Week 33: not at all
    662
    71%
    291
    62.2%
    Week 33: a little
    63
    6.8%
    39
    8.3%
    Week 33: quite a bit
    11
    1.2%
    8
    1.7%
    Week 33: very much
    1
    0.1%
    3
    0.6%
    Week 33: not answered
    0
    0%
    0
    0%
    Week 49: not at all
    577
    61.8%
    209
    44.7%
    Week 49: a little
    49
    5.3%
    34
    7.3%
    Week 49: quite a bit
    6
    0.6%
    3
    0.6%
    Week 49: very much
    3
    0.3%
    4
    0.9%
    Week 49: not answered
    0
    0%
    0
    0%
    Week 65: not at all
    492
    52.7%
    161
    34.4%
    Week 65: a little
    32
    3.4%
    29
    6.2%
    Week 65: quite a bit
    9
    1%
    2
    0.4%
    Week 65: very much
    3
    0.3%
    1
    0.2%
    Week 65: not answered
    0
    0%
    0
    0%
    Week 81: not at all
    389
    41.7%
    119
    25.4%
    Week 81: a little
    40
    4.3%
    27
    5.8%
    Week 81: quite a bit
    4
    0.4%
    2
    0.4%
    Week 81: very much
    1
    0.1%
    0
    0%
    Week 81: not answered
    0
    0%
    0
    0%
    Week 97: not at all
    332
    35.6%
    84
    17.9%
    Week 97: a little
    28
    3%
    11
    2.4%
    Week 97: quite a bit
    4
    0.4%
    0
    0%
    Week 97: very much
    1
    0.1%
    0
    0%
    Week 97: not answered
    0
    0%
    0
    0%
    Week 113: not at all
    247
    26.5%
    57
    12.2%
    Week 113: a little
    26
    2.8%
    13
    2.8%
    Week 113: quite a bit
    1
    0.1%
    3
    0.6%
    Week 113: very much
    1
    0.1%
    0
    0%
    Week 113: not answered
    0
    0%
    0
    0%
    Week 129: not at all
    173
    18.5%
    34
    7.3%
    Week 129: a little
    16
    1.7%
    7
    1.5%
    Week 129: quite a bit
    1
    0.1%
    0
    0%
    Week 129: very much
    2
    0.2%
    0
    0%
    Week 129: not answered
    0
    0%
    0
    0%
    Week 145: not at all
    102
    10.9%
    15
    3.2%
    Week 145: a little
    14
    1.5%
    6
    1.3%
    Week 145: quite a bit
    0
    0%
    0
    0%
    Week 145: very much
    0
    0%
    0
    0%
    Week 145: not answered
    0
    0%
    0
    0%
    Week 161: not at all
    36
    3.9%
    6
    1.3%
    Week 161: a little
    3
    0.3%
    1
    0.2%
    Week 161: quite a bit
    1
    0.1%
    1
    0.2%
    Week 161: very much
    0
    0%
    0
    0%
    Week 161: not answered
    0
    0%
    0
    0%
    Week 177: not at all
    6
    0.6%
    0
    0%
    Week 177: a little
    0
    0%
    1
    0.2%
    Week 177: quite a bit
    0
    0%
    0
    0%
    Week 177: very much
    0
    0%
    0
    0%
    Week 177: not answered
    0
    0%
    0
    0%
    24. Secondary Outcome
    TitleNumber of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 38
    DescriptionThe EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 38 are reported. Question 38 was following: "Has wearing an incontinence aid been a problem for you?". This question was answered by only those participants who wore incontinence aid.
    Time FrameBaseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified categories.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Baseline: not at all
    83
    8.9%
    37
    7.9%
    Baseline: a little
    40
    4.3%
    19
    4.1%
    Baseline: quite a bit
    15
    1.6%
    3
    0.6%
    Baseline: very much
    6
    0.6%
    8
    1.7%
    Baseline: not answered
    0
    0%
    0
    0%
    Week 17: not at all
    77
    8.3%
    34
    7.3%
    Week 17: a little
    48
    5.1%
    21
    4.5%
    Week 17: quite a bit
    15
    1.6%
    7
    1.5%
    Week 17: very much
    6
    0.6%
    6
    1.3%
    Week 17: not answered
    693
    74.3%
    351
    75%
    Week 33: not at all
    76
    8.1%
    30
    6.4%
    Week 33: a little
    47
    5%
    28
    6%
    Week 33: quite a bit
    16
    1.7%
    4
    0.9%
    Week 33: very much
    5
    0.5%
    4
    0.9%
    Week 33: not answered
    593
    63.6%
    275
    58.8%
    Week 49: not at all
    73
    7.8%
    18
    3.8%
    Week 49: a little
    43
    4.6%
    16
    3.4%
    Week 49: quite a bit
    12
    1.3%
    9
    1.9%
    Week 49: very much
    4
    0.4%
    2
    0.4%
    Week 49: not answered
    503
    53.9%
    205
    43.8%
    Week 65: not at all
    63
    6.8%
    12
    2.6%
    Week 65: a little
    40
    4.3%
    17
    3.6%
    Week 65: quite a bit
    9
    1%
    5
    1.1%
    Week 65: very much
    3
    0.3%
    1
    0.2%
    Week 65: not answered
    421
    45.1%
    158
    33.8%
    Week 81: not at all
    52
    5.6%
    15
    3.2%
    Week 81: a little
    33
    3.5%
    9
    1.9%
    Week 81: quite a bit
    10
    1.1%
    1
    0.2%
    Week 81: very much
    3
    0.3%
    3
    0.6%
    Week 81: not answered
    336
    36%
    120
    25.6%
    Week 97: not at all
    50
    5.4%
    8
    1.7%
    Week 97: a little
    28
    3%
    8
    1.7%
    Week 97: quite a bit
    7
    0.8%
    2
    0.4%
    Week 97: very much
    3
    0.3%
    0
    0%
    Week 97: not answered
    277
    29.7%
    77
    16.5%
    Week 113: not at all
    31
    3.3%
    12
    2.6%
    Week 113: a little
    18
    1.9%
    7
    1.5%
    Week 113: quite a bit
    8
    0.9%
    2
    0.4%
    Week 113: very much
    2
    0.2%
    0
    0%
    Week 113: not answered
    216
    23.2%
    52
    11.1%
    Week 129: not at all
    27
    2.9%
    5
    1.1%
    Week 129: a little
    18
    1.9%
    5
    1.1%
    Week 129: quite a bit
    2
    0.2%
    1
    0.2%
    Week 129: very much
    0
    0%
    0
    0%
    Week 129: not answered
    145
    15.5%
    30
    6.4%
    Week 145: not at all
    16
    1.7%
    2
    0.4%
    Week 145: a little
    10
    1.1%
    4
    0.9%
    Week 145: quite a bit
    5
    0.5%
    0
    0%
    Week 145: very much
    0
    0%
    0
    0%
    Week 145: not answered
    85
    9.1%
    15
    3.2%
    Week 161: not at all
    10
    1.1%
    1
    0.2%
    Week 161: a little
    3
    0.3%
    2
    0.4%
    Week 161: quite a bit
    1
    0.1%
    1
    0.2%
    Week 161: very much
    0
    0%
    0
    0%
    Week 161: not answered
    26
    2.8%
    4
    0.9%
    Week 177: not at all
    3
    0.3%
    0
    0%
    Week 177: a little
    1
    0.1%
    0
    0%
    Week 177: quite a bit
    0
    0%
    0
    0%
    Week 177: very much
    0
    0%
    0
    0%
    Week 177: not answered
    2
    0.2%
    1
    0.2%
    25. Secondary Outcome
    TitleNumber of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 39
    DescriptionThe EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 39 are reported. Question 39 was following: "Have your daily activities been limited by your urinary problems?"
    Time FrameBaseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified categories.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Baseline: not at all
    666
    71.4%
    338
    72.2%
    Baseline: a little
    173
    18.5%
    80
    17.1%
    Baseline: quite a bit
    35
    3.8%
    11
    2.4%
    Baseline: very much
    10
    1.1%
    10
    2.1%
    Baseline: not answered
    0
    0%
    0
    0%
    Week 17: not at all
    632
    67.7%
    305
    65.2%
    Week 17: a little
    160
    17.1%
    99
    21.2%
    Week 17: quite a bit
    36
    3.9%
    6
    1.3%
    Week 17: very much
    11
    1.2%
    9
    1.9%
    Week 17: not answered
    0
    0%
    0
    0%
    Week 33: not at all
    523
    56.1%
    242
    51.7%
    Week 33: a little
    172
    18.4%
    79
    16.9%
    Week 33: quite a bit
    31
    3.3%
    14
    3%
    Week 33: very much
    11
    1.2%
    6
    1.3%
    Week 33: not answered
    0
    0%
    0
    0%
    Week 49: not at all
    444
    47.6%
    173
    37%
    Week 49: a little
    152
    16.3%
    58
    12.4%
    Week 49: quite a bit
    31
    3.3%
    18
    3.8%
    Week 49: very much
    8
    0.9%
    1
    0.2%
    Week 49: not answered
    0
    0%
    0
    0%
    Week 65: not at all
    382
    40.9%
    128
    27.4%
    Week 65: a little
    124
    13.3%
    51
    10.9%
    Week 65: quite a bit
    20
    2.1%
    12
    2.6%
    Week 65: very much
    10
    1.1%
    2
    0.4%
    Week 65: not answered
    0
    0%
    0
    0%
    Week 81: not at all
    310
    33.2%
    103
    22%
    Week 81: a little
    98
    10.5%
    35
    7.5%
    Week 81: quite a bit
    21
    2.3%
    8
    1.7%
    Week 81: very much
    5
    0.5%
    2
    0.4%
    Week 81: not answered
    0
    0%
    0
    0%
    Week 97: not at all
    242
    25.9%
    72
    15.4%
    Week 97: a little
    100
    10.7%
    18
    3.8%
    Week 97: quite a bit
    18
    1.9%
    4
    0.9%
    Week 97: very much
    5
    0.5%
    1
    0.2%
    Week 97: not answered
    0
    0%
    0
    0%
    Week 113: not at all
    188
    20.2%
    54
    11.5%
    Week 113: a little
    71
    7.6%
    14
    3%
    Week 113: quite a bit
    13
    1.4%
    3
    0.6%
    Week 113: very much
    3
    0.3%
    2
    0.4%
    Week 113: not answered
    0
    0%
    0
    0%
    Week 129: not at all
    127
    13.6%
    25
    5.3%
    Week 129: a little
    55
    5.9%
    14
    3%
    Week 129: quite a bit
    7
    0.8%
    1
    0.2%
    Week 129: very much
    3
    0.3%
    1
    0.2%
    Week 129: not answered
    0
    0%
    0
    0%
    Week 145: not at all
    77
    8.3%
    11
    2.4%
    Week 145: a little
    34
    3.6%
    9
    1.9%
    Week 145: quite a bit
    4
    0.4%
    1
    0.2%
    Week 145: very much
    1
    0.1%
    0
    0%
    Week 145: not answered
    0
    0%
    0
    0%
    Week 161: not at all
    27
    2.9%
    2
    0.4%
    Week 161: a little
    10
    1.1%
    6
    1.3%
    Week 161: quite a bit
    3
    0.3%
    0
    0%
    Week 161: very much
    0
    0%
    0
    0%
    Week 161: not answered
    0
    0%
    0
    0%
    Week 177: not at all
    3
    0.3%
    0
    0%
    Week 177: a little
    3
    0.3%
    1
    0.2%
    Week 177: quite a bit
    0
    0%
    0
    0%
    Week 177: very much
    0
    0%
    0
    0%
    Week 177: not answered
    0
    0%
    0
    0%
    26. Secondary Outcome
    TitleNumber of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 40
    DescriptionThe EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 40 are reported. Question 40 was following: "Have your daily activities been limited by your bowel problems?"
    Time FrameBaseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified categories.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Baseline: not at all
    758
    81.2%
    393
    84%
    Baseline: a little
    112
    12%
    40
    8.5%
    Baseline: quite a bit
    9
    1%
    4
    0.9%
    Baseline: very much
    5
    0.5%
    2
    0.4%
    Baseline: not answered
    0
    0%
    0
    0%
    Week 17: not at all
    707
    75.8%
    352
    75.2%
    Week 17: a little
    107
    11.5%
    57
    12.2%
    Week 17: quite a bit
    19
    2%
    6
    1.3%
    Week 17: very much
    6
    0.6%
    4
    0.9%
    Week 17: not answered
    0
    0%
    0
    0%
    Week 33: not at all
    621
    66.6%
    292
    62.4%
    Week 33: a little
    98
    10.5%
    40
    8.5%
    Week 33: quite a bit
    14
    1.5%
    8
    1.7%
    Week 33: very much
    4
    0.4%
    1
    0.2%
    Week 33: not answered
    0
    0%
    0
    0%
    Week 49: not at all
    525
    56.3%
    211
    45.1%
    Week 49: a little
    88
    9.4%
    29
    6.2%
    Week 49: quite a bit
    20
    2.1%
    7
    1.5%
    Week 49: very much
    2
    0.2%
    3
    0.6%
    Week 49: not answered
    0
    0%
    0
    0%
    Week 65: not at all
    441
    47.3%
    165
    35.3%
    Week 65: a little
    78
    8.4%
    24
    5.1%
    Week 65: quite a bit
    11
    1.2%
    3
    0.6%
    Week 65: very much
    6
    0.6%
    1
    0.2%
    Week 65: not answered
    0
    0%
    0
    0%
    Week 81: not at all
    360
    38.6%
    121
    25.9%
    Week 81: a little
    56
    6%
    23
    4.9%
    Week 81: quite a bit
    17
    1.8%
    3
    0.6%
    Week 81: very much
    1
    0.1%
    1
    0.2%
    Week 81: not answered
    0
    0%
    0
    0%
    Week 97: not at all
    289
    31%
    84
    17.9%
    Week 97: a little
    58
    6.2%
    11
    2.4%
    Week 97: quite a bit
    17
    1.8%
    0
    0%
    Week 97: very much
    1
    0.1%
    0
    0%
    Week 97: not answered
    0
    0%
    0
    0%
    Week 113: not at all
    219
    23.5%
    62
    13.2%
    Week 113: a little
    46
    4.9%
    11
    2.4%
    Week 113: quite a bit
    8
    0.9%
    0
    0%
    Week 113: very much
    2
    0.2%
    0
    0%
    Week 113: not answered
    0
    0%
    0
    0%
    Week 129: not at all
    153
    16.4%
    36
    7.7%
    Week 129: a little
    33
    3.5%
    5
    1.1%
    Week 129: quite a bit
    5
    0.5%
    0
    0%
    Week 129: very much
    1
    0.1%
    0
    0%
    Week 129: not answered
    0
    0%
    0
    0%
    Week 145: not at all
    93
    10%
    17
    3.6%
    Week 145: a little
    19
    2%
    4
    0.9%
    Week 145: quite a bit
    4
    0.4%
    0
    0%
    Week 145: very much
    0
    0%
    0
    0%
    Week 145: not answered
    0
    0%
    0
    0%
    Week 161: not at all
    29
    3.1%
    8
    1.7%
    Week 161: a little
    9
    1%
    0
    0%
    Week 161: quite a bit
    2
    0.2%
    0
    0%
    Week 161: very much
    0
    0%
    0
    0%
    Week 161: not answered
    0
    0%
    0
    0%
    Week 177: not at all
    4
    0.4%
    1
    0.2%
    Week 177: a little
    2
    0.2%
    0
    0%
    Week 177: quite a bit
    0
    0%
    0
    0%
    Week 177: very much
    0
    0%
    0
    0%
    Week 177: not answered
    0
    0%
    0
    0%
    27. Secondary Outcome
    TitleNumber of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 41
    DescriptionThe EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 41 are reported. Question 41 was following: "Have you had any unintentional release (leakage) of stools?"
    Time FrameBaseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified categories.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Baseline: not at all
    794
    85.1%
    404
    86.3%
    Baseline: a little
    78
    8.4%
    32
    6.8%
    Baseline: quite a bit
    11
    1.2%
    2
    0.4%
    Baseline: very much
    1
    0.1%
    1
    0.2%
    Baseline: not answered
    0
    0%
    0
    0%
    Week 17: not at all
    751
    80.5%
    372
    79.5%
    Week 17: a little
    79
    8.5%
    43
    9.2%
    Week 17: quite a bit
    8
    0.9%
    3
    0.6%
    Week 17: very much
    1
    0.1%
    1
    0.2%
    Week 17: not answered
    0
    0%
    0
    0%
    Week 33: not at all
    638
    68.4%
    307
    65.6%
    Week 33: a little
    92
    9.9%
    32
    6.8%
    Week 33: quite a bit
    4
    0.4%
    1
    0.2%
    Week 33: very much
    3
    0.3%
    1
    0.2%
    Week 33: not answered
    0
    0%
    0
    0%
    Week 49: not at all
    554
    59.4%
    221
    47.2%
    Week 49: a little
    73
    7.8%
    25
    5.3%
    Week 49: quite a bit
    5
    0.5%
    4
    0.9%
    Week 49: very much
    3
    0.3%
    0
    0%
    Week 49: not answered
    0
    0%
    0
    0%
    Week 65: not at all
    467
    50.1%
    175
    37.4%
    Week 65: a little
    57
    6.1%
    16
    3.4%
    Week 65: quite a bit
    9
    1%
    1
    0.2%
    Week 65: very much
    3
    0.3%
    1
    0.2%
    Week 65: not answered
    0
    0%
    0
    0%
    Week 81: not at all
    380
    40.7%
    136
    29.1%
    Week 81: a little
    51
    5.5%
    12
    2.6%
    Week 81: quite a bit
    2
    0.2%
    0
    0%
    Week 81: very much
    1
    0.1%
    0
    0%
    Week 81: not answered
    0
    0%
    0
    0%
    Week 97: not at all
    315
    33.8%
    86
    18.4%
    Week 97: a little
    47
    5%
    9
    1.9%
    Week 97: quite a bit
    3
    0.3%
    0
    0%
    Week 97: very much
    0
    0%
    0
    0%
    Week 97: not answered
    0
    0%
    0
    0%
    Week 113: not at all
    233
    25%
    66
    14.1%
    Week 113: a little
    40
    4.3%
    7
    1.5%
    Week 113: quite a bit
    2
    0.2%
    0
    0%
    Week 113: very much
    0
    0%
    0
    0%
    Week 113: not answered
    0
    0%
    0
    0%
    Week 129: not at all
    167
    17.9%
    39
    8.3%
    Week 129: a little
    25
    2.7%
    2
    0.4%
    Week 129: quite a bit
    0
    0%
    0
    0%
    Week 129: very much
    0
    0%
    0
    0%
    Week 129: not answered
    0
    0%
    0
    0%
    Week 145: not at all
    93
    10%
    20
    4.3%
    Week 145: a little
    22
    2.4%
    1
    0.2%
    Week 145: quite a bit
    0
    0%
    0
    0%
    Week 145: very much
    1
    0.1%
    0
    0%
    Week 145: not answered
    0
    0%
    0
    0%
    Week 161: not at all
    30
    3.2%
    8
    1.7%
    Week 161: a little
    9
    1%
    0
    0%
    Week 161: quite a bit
    0
    0%
    0
    0%
    Week 161: very much
    1
    0.1%
    0
    0%
    Week 161: not answered
    0
    0%
    0
    0%
    Week 177: not at all
    4
    0.4%
    1
    0.2%
    Week 177: a little
    2
    0.2%
    0
    0%
    Week 177: quite a bit
    0
    0%
    0
    0%
    Week 177: very much
    0
    0%
    0
    0%
    Week 177: not answered
    0
    0%
    0
    0%
    28. Secondary Outcome
    TitleNumber of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 42
    DescriptionThe EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 42 are reported. Question 42 was following: "Have you had blood in your stools?"
    Time FrameBaseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified categories.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Baseline: not at all
    836
    89.6%
    422
    90.2%
    Baseline: a little
    48
    5.1%
    17
    3.6%
    Baseline: quite a bit
    0
    0%
    0
    0%
    Baseline: very much
    0
    0%
    0
    0%
    Baseline: not answered
    0
    0%
    0
    0%
    Week 17: not at all
    801
    85.9%
    399
    85.3%
    Week 17: a little
    36
    3.9%
    18
    3.8%
    Week 17: quite a bit
    2
    0.2%
    2
    0.4%
    Week 17: very much
    0
    0%
    0
    0%
    Week 17: not answered
    0
    0%
    0
    0%
    Week 33: not at all
    707
    75.8%
    330
    70.5%
    Week 33: a little
    29
    3.1%
    11
    2.4%
    Week 33: quite a bit
    1
    0.1%
    0
    0%
    Week 33: very much
    0
    0%
    0
    0%
    Week 33: not answered
    0
    0%
    0
    0%
    Week 49: not at all
    608
    65.2%
    245
    52.4%
    Week 49: a little
    27
    2.9%
    5
    1.1%
    Week 49: quite a bit
    0
    0%
    0
    0%
    Week 49: very much
    0
    0%
    0
    0%
    Week 49: not answered
    0
    0%
    0
    0%
    Week 65: not at all
    514
    55.1%
    180
    38.5%
    Week 65: a little
    19
    2%
    13
    2.8%
    Week 65: quite a bit
    3
    0.3%
    0
    0%
    Week 65: very much
    0
    0%
    0
    0%
    Week 65: not answered
    0
    0%
    0
    0%
    Week 81: not at all
    420
    45%
    143
    30.6%
    Week 81: a little
    14
    1.5%
    4
    0.9%
    Week 81: quite a bit
    0
    0%
    1
    0.2%
    Week 81: very much
    0
    0%
    0
    0%
    Week 81: not answered
    0
    0%
    0
    0%
    Week 97: not at all
    357
    38.3%
    93
    19.9%
    Week 97: a little
    8
    0.9%
    2
    0.4%
    Week 97: quite a bit
    0
    0%
    0
    0%
    Week 97: very much
    0
    0%
    0
    0%
    Week 97: not answered
    0
    0%
    0
    0%
    Week 113: not at all
    262
    28.1%
    72
    15.4%
    Week 113: a little
    13
    1.4%
    1
    0.2%
    Week 113: quite a bit
    0
    0%
    0
    0%
    Week 113: very much
    0
    0%
    0
    0%
    Week 113: not answered
    0
    0%
    0
    0%
    Week 129: not at all
    186
    19.9%
    41
    8.8%
    Week 129: a little
    5
    0.5%
    0
    0%
    Week 129: quite a bit
    1
    0.1%
    0
    0%
    Week 129: very much
    0
    0%
    0
    0%
    Week 129: not answered
    0
    0%
    0
    0%
    Week 145: not at all
    114
    12.2%
    21
    4.5%
    Week 145: a little
    2
    0.2%
    0
    0%
    Week 145: quite a bit
    0
    0%
    0
    0%
    Week 145: very much
    0
    0%
    0
    0%
    Week 145: not answered
    0
    0%
    0
    0%
    Week 161: not at all
    38
    4.1%
    8
    1.7%
    Week 161: a little
    2
    0.2%
    0
    0%
    Week 161: quite a bit
    0
    0%
    0
    0%
    Week 161: very much
    0
    0%
    0
    0%
    Week 161: not answered
    0
    0%
    0
    0%
    Week 177: not at all
    6
    0.6%
    1
    0.2%
    Week 177: a little
    0
    0%
    0
    0%
    Week 177: quite a bit
    0
    0%
    0
    0%
    Week 177: very much
    0
    0%
    0
    0%
    Week 177: not answered
    0
    0%
    0
    0%
    29. Secondary Outcome
    TitleNumber of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 43
    DescriptionThe EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 43 are reported. Question 43 was following: "Did you have a bloated feeling in your abdomen?"
    Time FrameBaseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified categories.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Baseline: not at all
    667
    71.5%
    320
    68.4%
    Baseline: a little
    190
    20.4%
    103
    22%
    Baseline: quite a bit
    22
    2.4%
    16
    3.4%
    Baseline: very much
    5
    0.5%
    0
    0%
    Baseline: not answered
    0
    0%
    0
    0%
    Week 17: not at all
    601
    64.4%
    283
    60.5%
    Week 17: a little
    199
    21.3%
    121
    25.9%
    Week 17: quite a bit
    31
    3.3%
    13
    2.8%
    Week 17: very much
    8
    0.9%
    2
    0.4%
    Week 17: not answered
    0
    0%
    0
    0%
    Week 33: not at all
    526
    56.4%
    235
    50.2%
    Week 33: a little
    183
    19.6%
    95
    20.3%
    Week 33: quite a bit
    22
    2.4%
    8
    1.7%
    Week 33: very much
    6
    0.6%
    3
    0.6%
    Week 33: not answered
    0
    0%
    0
    0%
    Week 49: not at all
    449
    48.1%
    174
    37.2%
    Week 49: a little
    163
    17.5%
    63
    13.5%
    Week 49: quite a bit
    20
    2.1%
    11
    2.4%
    Week 49: very much
    3
    0.3%
    2
    0.4%
    Week 49: not answered
    0
    0%
    0
    0%
    Week 65: not at all
    381
    40.8%
    135
    28.8%
    Week 65: a little
    132
    14.1%
    51
    10.9%
    Week 65: quite a bit
    19
    2%
    7
    1.5%
    Week 65: very much
    4
    0.4%
    0
    0%
    Week 65: not answered
    0
    0%
    0
    0%
    Week 81: not at all
    304
    32.6%
    103
    22%
    Week 81: a little
    110
    11.8%
    44
    9.4%
    Week 81: quite a bit
    18
    1.9%
    1
    0.2%
    Week 81: very much
    2
    0.2%
    0
    0%
    Week 81: not answered
    0
    0%
    0
    0%
    Week 97: not at all
    258
    27.7%
    72
    15.4%
    Week 97: a little
    87
    9.3%
    23
    4.9%
    Week 97: quite a bit
    19
    2%
    0
    0%
    Week 97: very much
    1
    0.1%
    0
    0%
    Week 97: not answered
    0
    0%
    0
    0%
    Week 113: not at all
    199
    21.3%
    55
    11.8%
    Week 113: a little
    66
    7.1%
    18
    3.8%
    Week 113: quite a bit
    9
    1%
    0
    0%
    Week 113: very much
    1
    0.1%
    0
    0%
    Week 113: not answered
    0
    0%
    0
    0%
    Week 129: not at all
    139
    14.9%
    25
    5.3%
    Week 129: a little
    43
    4.6%
    16
    3.4%
    Week 129: quite a bit
    8
    0.9%
    0
    0%
    Week 129: very much
    2
    0.2%
    0
    0%
    Week 129: not answered
    0
    0%
    0
    0%
    Week 145: not at all
    87
    9.3%
    13
    2.8%
    Week 145: a little
    24
    2.6%
    8
    1.7%
    Week 145: quite a bit
    4
    0.4%
    0
    0%
    Week 145: very much
    1
    0.1%
    0
    0%
    Week 145: not answered
    0
    0%
    0
    0%
    Week 161: not at all
    33
    3.5%
    6
    1.3%
    Week 161: a little
    7
    0.8%
    2
    0.4%
    Week 161: quite a bit
    0
    0%
    0
    0%
    Week 161: very much
    0
    0%
    0
    0%
    Week 161: not answered
    0
    0%
    0
    0%
    Week 177: not at all
    4
    0.4%
    0
    0%
    Week 177: a little
    2
    0.2%
    1
    0.2%
    Week 177: quite a bit
    0
    0%
    0
    0%
    Week 177: very much
    0
    0%
    0
    0%
    Week 177: not answered
    0
    0%
    0
    0%
    30. Secondary Outcome
    TitleNumber of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 44
    DescriptionThe EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 44 are reported. Question 44 was following: "Did you have hot flushes?"
    Time FrameBaseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified categories.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Baseline: not at all
    374
    40.1%
    177
    37.8%
    Baseline: a little
    314
    33.7%
    166
    35.5%
    Baseline: quite a bit
    151
    16.2%
    68
    14.5%
    Baseline: very much
    45
    4.8%
    28
    6%
    Baseline: not answered
    0
    0%
    0
    0%
    Week 17: not at all
    265
    28.4%
    182
    38.9%
    Week 17: a little
    311
    33.3%
    153
    32.7%
    Week 17: quite a bit
    189
    20.3%
    62
    13.2%
    Week 17: very much
    74
    7.9%
    22
    4.7%
    Week 17: not answered
    0
    0%
    0
    0%
    Week 33: not at all
    253
    27.1%
    144
    30.8%
    Week 33: a little
    268
    28.7%
    116
    24.8%
    Week 33: quite a bit
    155
    16.6%
    60
    12.8%
    Week 33: very much
    61
    6.5%
    21
    4.5%
    Week 33: not answered
    0
    0%
    0
    0%
    Week 49: not at all
    227
    24.3%
    112
    23.9%
    Week 49: a little
    235
    25.2%
    94
    20.1%
    Week 49: quite a bit
    130
    13.9%
    30
    6.4%
    Week 49: very much
    43
    4.6%
    14
    3%
    Week 49: not answered
    0
    0%
    0
    0%
    Week 65: not at all
    203
    21.8%
    79
    16.9%
    Week 65: a little
    194
    20.8%
    77
    16.5%
    Week 65: quite a bit
    104
    11.1%
    30
    6.4%
    Week 65: very much
    35
    3.8%
    7
    1.5%
    Week 65: not answered
    0
    0%
    0
    0%
    Week 81: not at all
    175
    18.8%
    69
    14.7%
    Week 81: a little
    157
    16.8%
    58
    12.4%
    Week 81: quite a bit
    75
    8%
    16
    3.4%
    Week 81: very much
    27
    2.9%
    5
    1.1%
    Week 81: not answered
    0
    0%
    0
    0%
    Week 97: not at all
    155
    16.6%
    48
    10.3%
    Week 97: a little
    126
    13.5%
    34
    7.3%
    Week 97: quite a bit
    57
    6.1%
    12
    2.6%
    Week 97: very much
    27
    2.9%
    1
    0.2%
    Week 97: not answered
    0
    0%
    0
    0%
    Week 113: not at all
    114
    12.2%
    33
    7.1%
    Week 113: a little
    102
    10.9%
    24
    5.1%
    Week 113: quite a bit
    44
    4.7%
    14
    3%
    Week 113: very much
    15
    1.6%
    2
    0.4%
    Week 113: not answered
    0
    0%
    0
    0%
    Week 129: not at all
    84
    9%
    22
    4.7%
    Week 129: a little
    74
    7.9%
    16
    3.4%
    Week 129: quite a bit
    23
    2.5%
    3
    0.6%
    Week 129: very much
    11
    1.2%
    0
    0%
    Week 129: not answered
    0
    0%
    0
    0%
    Week 145: not at all
    45
    4.8%
    10
    2.1%
    Week 145: a little
    46
    4.9%
    10
    2.1%
    Week 145: quite a bit
    18
    1.9%
    0
    0%
    Week 145: very much
    7
    0.8%
    1
    0.2%
    Week 145: not answered
    0
    0%
    0
    0%
    Week 161: not at all
    18
    1.9%
    3
    0.6%
    Week 161: a little
    14
    1.5%
    3
    0.6%
    Week 161: quite a bit
    5
    0.5%
    2
    0.4%
    Week 161: very much
    3
    0.3%
    0
    0%
    Week 161: not answered
    0
    0%
    0
    0%
    Week 177: not at all
    3
    0.3%
    0
    0%
    Week 177: a little
    0
    0%
    0
    0%
    Week 177: quite a bit
    1
    0.1%
    1
    0.2%
    Week 177: very much
    2
    0.2%
    0
    0%
    Week 177: not answered
    0
    0%
    0
    0%
    31. Secondary Outcome
    TitleNumber of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 45
    DescriptionThe EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 45 are reported. Question 45 was following: "Have you had sore or enlarged nipples or breasts?"
    Time FrameBaseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified categories.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Baseline: not at all
    688
    73.7%
    333
    71.2%
    Baseline: a little
    146
    15.6%
    80
    17.1%
    Baseline: quite a bit
    38
    4.1%
    24
    5.1%
    Baseline: very much
    12
    1.3%
    2
    0.4%
    Baseline: not answered
    0
    0%
    0
    0%
    Week 17: not at all
    626
    67.1%
    315
    67.3%
    Week 17: a little
    160
    17.1%
    80
    17.1%
    Week 17: quite a bit
    39
    4.2%
    18
    3.8%
    Week 17: very much
    14
    1.5%
    6
    1.3%
    Week 17: not answered
    0
    0%
    0
    0%
    Week 33: not at all
    526
    56.4%
    260
    55.6%
    Week 33: a little
    164
    17.6%
    62
    13.2%
    Week 33: quite a bit
    34
    3.6%
    15
    3.2%
    Week 33: very much
    13
    1.4%
    4
    0.9%
    Week 33: not answered
    0
    0%
    0
    0%
    Week 49: not at all
    444
    47.6%
    188
    40.2%
    Week 49: a little
    138
    14.8%
    52
    11.1%
    Week 49: quite a bit
    41
    4.4%
    5
    1.1%
    Week 49: very much
    12
    1.3%
    5
    1.1%
    Week 49: not answered
    0
    0%
    0
    0%
    Week 65: not at all
    371
    39.8%
    149
    31.8%
    Week 65: a little
    119
    12.8%
    37
    7.9%
    Week 65: quite a bit
    31
    3.3%
    7
    1.5%
    Week 65: very much
    15
    1.6%
    0
    0%
    Week 65: not answered
    0
    0%
    0
    0%
    Week 81: not at all
    306
    32.8%
    115
    24.6%
    Week 81: a little
    84
    9%
    26
    5.6%
    Week 81: quite a bit
    34
    3.6%
    6
    1.3%
    Week 81: very much
    10
    1.1%
    1
    0.2%
    Week 81: not answered
    0
    0%
    0
    0%
    Week 97: not at all
    239
    25.6%
    80
    17.1%
    Week 97: a little
    92
    9.9%
    13
    2.8%
    Week 97: quite a bit
    30
    3.2%
    1
    0.2%
    Week 97: very much
    4
    0.4%
    1
    0.2%
    Week 97: not answered
    0
    0%
    0
    0%
    Week 113: not at all
    190
    20.4%
    55
    11.8%
    Week 113: a little
    62
    6.6%
    12
    2.6%
    Week 113: quite a bit
    19
    2%
    5
    1.1%
    Week 113: very much
    4
    0.4%
    1
    0.2%
    Week 113: not answered
    0
    0%
    0
    0%
    Week 129: not at all
    128
    13.7%
    30
    6.4%
    Week 129: a little
    51
    5.5%
    8
    1.7%
    Week 129: quite a bit
    9
    1%
    3
    0.6%
    Week 129: very much
    4
    0.4%
    0
    0%
    Week 129: not answered
    0
    0%
    0
    0%
    Week 145: not at all
    78
    8.4%
    17
    3.6%
    Week 145: a little
    29
    3.1%
    3
    0.6%
    Week 145: quite a bit
    7
    0.8%
    1
    0.2%
    Week 145: very much
    2
    0.2%
    0
    0%
    Week 145: not answered
    0
    0%
    0
    0%
    Week 161: not at all
    26
    2.8%
    4
    0.9%
    Week 161: a little
    11
    1.2%
    3
    0.6%
    Week 161: quite a bit
    1
    0.1%
    0
    0%
    Week 161: very much
    2
    0.2%
    1
    0.2%
    Week 161: not answered
    0
    0%
    0
    0%
    Week 177: not at all
    2
    0.2%
    0
    0%
    Week 177: a little
    2
    0.2%
    1
    0.2%
    Week 177: quite a bit
    2
    0.2%
    0
    0%
    Week 177: very much
    0
    0%
    0
    0%
    Week 177: not answered
    0
    0%
    0
    0%
    32. Secondary Outcome
    TitleNumber of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 46
    DescriptionThe EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 46 are reported. Question 46 was following: "Have you had swelling in your legs or ankles?"
    Time FrameBaseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified categories.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Baseline: not at all
    663
    71.1%
    323
    69%
    Baseline: a little
    189
    20.3%
    89
    19%
    Baseline: quite a bit
    22
    2.4%
    22
    4.7%
    Baseline: very much
    10
    1.1%
    5
    1.1%
    Baseline: not answered
    0
    0%
    0
    0%
    Week 17: not at all
    625
    67%
    284
    60.7%
    Week 17: a little
    179
    19.2%
    112
    23.9%
    Week 17: quite a bit
    30
    3.2%
    21
    4.5%
    Week 17: very much
    5
    0.5%
    2
    0.4%
    Week 17: not answered
    0
    0%
    0
    0%
    Week 33: not at all
    530
    56.8%
    243
    51.9%
    Week 33: a little
    159
    17%
    76
    16.2%
    Week 33: quite a bit
    41
    4.4%
    20
    4.3%
    Week 33: very much
    7
    0.8%
    2
    0.4%
    Week 33: not answered
    0
    0%
    0
    0%
    Week 49: not at all
    453
    48.6%
    176
    37.6%
    Week 49: a little
    155
    16.6%
    58
    12.4%
    Week 49: quite a bit
    23
    2.5%
    15
    3.2%
    Week 49: very much
    4
    0.4%
    1
    0.2%
    Week 49: not answered
    0
    0%
    0
    0%
    Week 65: not at all
    378
    40.5%
    135
    28.8%
    Week 65: a little
    127
    13.6%
    48
    10.3%
    Week 65: quite a bit
    27
    2.9%
    10
    2.1%
    Week 65: very much
    4
    0.4%
    0
    0%
    Week 65: not answered
    0
    0%
    0
    0%
    Week 81: not at all
    301
    32.3%
    104
    22.2%
    Week 81: a little
    102
    10.9%
    36
    7.7%
    Week 81: quite a bit
    27
    2.9%
    7
    1.5%
    Week 81: very much
    4
    0.4%
    1
    0.2%
    Week 81: not answered
    0
    0%
    0
    0%
    Week 97: not at all
    259
    27.8%
    69
    14.7%
    Week 97: a little
    79
    8.5%
    20
    4.3%
    Week 97: quite a bit
    19
    2%
    5
    1.1%
    Week 97: very much
    8
    0.9%
    1
    0.2%
    Week 97: not answered
    0
    0%
    0
    0%
    Week 113: not at all
    191
    20.5%
    40
    8.5%
    Week 113: a little
    65
    7%
    27
    5.8%
    Week 113: quite a bit
    16
    1.7%
    6
    1.3%
    Week 113: very much
    3
    0.3%
    0
    0%
    Week 113: not answered
    0
    0%
    0
    0%
    Week 129: not at all
    134
    14.4%
    27
    5.8%
    Week 129: a little
    48
    5.1%
    14
    3%
    Week 129: quite a bit
    8
    0.9%
    0
    0%
    Week 129: very much
    2
    0.2%
    0
    0%
    Week 129: not answered
    0
    0%
    0
    0%
    Week 145: not at all
    76
    8.1%
    15
    3.2%
    Week 145: a little
    34
    3.6%
    5
    1.1%
    Week 145: quite a bit
    5
    0.5%
    1
    0.2%
    Week 145: very much
    1
    0.1%
    0
    0%
    Week 145: not answered
    0
    0%
    0
    0%
    Week 161: not at all
    31
    3.3%
    6
    1.3%
    Week 161: a little
    8
    0.9%
    2
    0.4%
    Week 161: quite a bit
    1
    0.1%
    0
    0%
    Week 161: very much
    0
    0%
    0
    0%
    Week 161: not answered
    0
    0%
    0
    0%
    Week 177: not at all
    3
    0.3%
    0
    0%
    Week 177: a little
    3
    0.3%
    0
    0%
    Week 177: quite a bit
    0
    0%
    1
    0.2%
    Week 177: very much
    0
    0%
    0
    0%
    Week 177: not answered
    0
    0%
    0
    0%
    33. Secondary Outcome
    TitleNumber of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 47
    DescriptionThe EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 47 are reported. Question 47 was following: "Has weight loss been a problem for you?"
    Time FrameBaseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified categories.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Baseline: not at all
    820
    87.9%
    399
    85.3%
    Baseline: a little
    48
    5.1%
    25
    5.3%
    Baseline: quite a bit
    10
    1.1%
    10
    2.1%
    Baseline: very much
    6
    0.6%
    5
    1.1%
    Baseline: not answered
    0
    0%
    0
    0%
    Week 17: not at all
    733
    78.6%
    375
    80.1%
    Week 17: a little
    81
    8.7%
    28
    6%
    Week 17: quite a bit
    15
    1.6%
    13
    2.8%
    Week 17: very much
    10
    1.1%
    3
    0.6%
    Week 17: not answered
    0
    0%
    0
    0%
    Week 33: not at all
    643
    68.9%
    296
    63.2%
    Week 33: a little
    72
    7.7%
    35
    7.5%
    Week 33: quite a bit
    13
    1.4%
    5
    1.1%
    Week 33: very much
    9
    1%
    5
    1.1%
    Week 33: not answered
    0
    0%
    0
    0%
    Week 49: not at all
    553
    59.3%
    215
    45.9%
    Week 49: a little
    61
    6.5%
    29
    6.2%
    Week 49: quite a bit
    15
    1.6%
    3
    0.6%
    Week 49: very much
    6
    0.6%
    3
    0.6%
    Week 49: not answered
    0
    0%
    0
    0%
    Week 65: not at all
    479
    51.3%
    168
    35.9%
    Week 65: a little
    39
    4.2%
    20
    4.3%
    Week 65: quite a bit
    11
    1.2%
    4
    0.9%
    Week 65: very much
    7
    0.8%
    1
    0.2%
    Week 65: not answered
    0
    0%
    0
    0%
    Week 81: not at all
    371
    39.8%
    136
    29.1%
    Week 81: a little
    46
    4.9%
    10
    2.1%
    Week 81: quite a bit
    14
    1.5%
    1
    0.2%
    Week 81: very much
    3
    0.3%
    1
    0.2%
    Week 81: not answered
    0
    0%
    0
    0%
    Week 97: not at all
    314
    33.7%
    84
    17.9%
    Week 97: a little
    36
    3.9%
    10
    2.1%
    Week 97: quite a bit
    10
    1.1%
    0
    0%
    Week 97: very much
    5
    0.5%
    1
    0.2%
    Week 97: not answered
    0
    0%
    0
    0%
    Week 113: not at all
    235
    25.2%
    62
    13.2%
    Week 113: a little
    27
    2.9%
    8
    1.7%
    Week 113: quite a bit
    9
    1%
    1
    0.2%
    Week 113: very much
    4
    0.4%
    2
    0.4%
    Week 113: not answered
    0
    0%
    0
    0%
    Week 129: not at all
    169
    18.1%
    37
    7.9%
    Week 129: a little
    17
    1.8%
    4
    0.9%
    Week 129: quite a bit
    5
    0.5%
    0
    0%
    Week 129: very much
    1
    0.1%
    0
    0%
    Week 129: not answered
    0
    0%
    0
    0%
    Week 145: not at all
    95
    10.2%
    20
    4.3%
    Week 145: a little
    17
    1.8%
    1
    0.2%
    Week 145: quite a bit
    4
    0.4%
    0
    0%
    Week 145: very much
    0
    0%
    0
    0%
    Week 145: not answered
    0
    0%
    0
    0%
    Week 161: not at all
    34
    3.6%
    8
    1.7%
    Week 161: a little
    5
    0.5%
    0
    0%
    Week 161: quite a bit
    1
    0.1%
    0
    0%
    Week 161: very much
    0
    0%
    0
    0%
    Week 161: not answered
    0
    0%
    0
    0%
    Week 177: not at all
    5
    0.5%
    1
    0.2%
    Week 177: a little
    0
    0%
    0
    0%
    Week 177: quite a bit
    1
    0.1%
    0
    0%
    Week 177: very much
    0
    0%
    0
    0%
    Week 177: not answered
    0
    0%
    0
    0%
    34. Secondary Outcome
    TitleNumber of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 48
    DescriptionThe EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 48 are reported. Question 48 was following: "Has weight gain been a problem for you?"
    Time FrameBaseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified categories.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Baseline: not at all
    677
    72.6%
    315
    67.3%
    Baseline: a little
    153
    16.4%
    95
    20.3%
    Baseline: quite a bit
    40
    4.3%
    16
    3.4%
    Baseline: very much
    14
    1.5%
    13
    2.8%
    Baseline: not answered
    0
    0%
    0
    0%
    Week 17: not at all
    674
    72.2%
    316
    67.5%
    Week 17: a little
    118
    12.6%
    74
    15.8%
    Week 17: quite a bit
    30
    3.2%
    19
    4.1%
    Week 17: very much
    17
    1.8%
    10
    2.1%
    Week 17: not answered
    0
    0%
    0
    0%
    Week 33: not at all
    570
    61.1%
    259
    55.3%
    Week 33: a little
    133
    14.3%
    59
    12.6%
    Week 33: quite a bit
    21
    2.3%
    18
    3.8%
    Week 33: very much
    13
    1.4%
    5
    1.1%
    Week 33: not answered
    0
    0%
    0
    0%
    Week 49: not at all
    479
    51.3%
    193
    41.2%
    Week 49: a little
    125
    13.4%
    44
    9.4%
    Week 49: quite a bit
    18
    1.9%
    10
    2.1%
    Week 49: very much
    13
    1.4%
    3
    0.6%
    Week 49: not answered
    0
    0%
    0
    0%
    Week 65: not at all
    410
    43.9%
    155
    33.1%
    Week 65: a little
    92
    9.9%
    27
    5.8%
    Week 65: quite a bit
    26
    2.8%
    9
    1.9%
    Week 65: very much
    8
    0.9%
    2
    0.4%
    Week 65: not answered
    0
    0%
    0
    0%
    Week 81: not at all
    327
    35%
    115
    24.6%
    Week 81: a little
    71
    7.6%
    27
    5.8%
    Week 81: quite a bit
    28
    3%
    5
    1.1%
    Week 81: very much
    8
    0.9%
    1
    0.2%
    Week 81: not answered
    0
    0%
    0
    0%
    Week 97: not at all
    267
    28.6%
    76
    16.2%
    Week 97: a little
    70
    7.5%
    16
    3.4%
    Week 97: quite a bit
    24
    2.6%
    2
    0.4%
    Week 97: very much
    4
    0.4%
    1
    0.2%
    Week 97: not answered
    0
    0%
    0
    0%
    Week 113: not at all
    200
    21.4%
    60
    12.8%
    Week 113: a little
    56
    6%
    10
    2.1%
    Week 113: quite a bit
    10
    1.1%
    3
    0.6%
    Week 113: very much
    9
    1%
    0
    0%
    Week 113: not answered
    0
    0%
    0
    0%
    Week 129: not at all
    156
    16.7%
    32
    6.8%
    Week 129: a little
    27
    2.9%
    8
    1.7%
    Week 129: quite a bit
    5
    0.5%
    1
    0.2%
    Week 129: very much
    4
    0.4%
    0
    0%
    Week 129: not answered
    0
    0%
    0
    0%
    Week 145: not at all
    89
    9.5%
    16
    3.4%
    Week 145: a little
    18
    1.9%
    5
    1.1%
    Week 145: quite a bit
    7
    0.8%
    0
    0%
    Week 145: very much
    2
    0.2%
    0
    0%
    Week 145: not answered
    0
    0%
    0
    0%
    Week 161: not at all
    31
    3.3%
    6
    1.3%
    Week 161: a little
    6
    0.6%
    2
    0.4%
    Week 161: quite a bit
    1
    0.1%
    0
    0%
    Week 161: very much
    2
    0.2%
    0
    0%
    Week 161: not answered
    0
    0%
    0
    0%
    Week 177: not at all
    2
    0.2%
    0
    0%
    Week 177: a little
    3
    0.3%
    1
    0.2%
    Week 177: quite a bit
    1
    0.1%
    0
    0%
    Week 177: very much
    0
    0%
    0
    0%
    Week 177: not answered
    0
    0%
    0
    0%
    35. Secondary Outcome
    TitleNumber of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 49
    DescriptionThe EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 49 are reported. Question 49 was following: "Have you felt less masculine as a result of your illness or treatment?"
    Time FrameBaseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified categories.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Baseline: not at all
    435
    46.6%
    214
    45.7%
    Baseline: a little
    234
    25.1%
    131
    28%
    Baseline: quite a bit
    138
    14.8%
    59
    12.6%
    Baseline: very much
    77
    8.3%
    35
    7.5%
    Baseline: not answered
    0
    0%
    0
    0%
    Week 17: not at all
    400
    42.9%
    210
    44.9%
    Week 17: a little
    244
    26.2%
    115
    24.6%
    Week 17: quite a bit
    109
    11.7%
    57
    12.2%
    Week 17: very much
    86
    9.2%
    37
    7.9%
    Week 17: not answered
    0
    0%
    0
    0%
    Week 33: not at all
    345
    37%
    167
    35.7%
    Week 33: a little
    207
    22.2%
    107
    22.9%
    Week 33: quite a bit
    109
    11.7%
    38
    8.1%
    Week 33: very much
    76
    8.1%
    29
    6.2%
    Week 33: not answered
    0
    0%
    0
    0%
    Week 49: not at all
    302
    32.4%
    127
    27.1%
    Week 49: a little
    187
    20%
    68
    14.5%
    Week 49: quite a bit
    84
    9%
    36
    7.7%
    Week 49: very much
    62
    6.6%
    19
    4.1%
    Week 49: not answered
    0
    0%
    0
    0%
    Week 65: not at all
    263
    28.2%
    90
    19.2%
    Week 65: a little
    142
    15.2%
    57
    12.2%
    Week 65: quite a bit
    71
    7.6%
    24
    5.1%
    Week 65: very much
    60
    6.4%
    22
    4.7%
    Week 65: not answered
    0
    0%
    0
    0%
    Week 81: not at all
    206
    22.1%
    74
    15.8%
    Week 81: a little
    124
    13.3%
    38
    8.1%
    Week 81: quite a bit
    57
    6.1%
    17
    3.6%
    Week 81: very much
    47
    5%
    19
    4.1%
    Week 81: not answered
    0
    0%
    0
    0%
    Week 97: not at all
    175
    18.8%
    46
    9.8%
    Week 97: a little
    98
    10.5%
    28
    6%
    Week 97: quite a bit
    47
    5%
    10
    2.1%
    Week 97: very much
    45
    4.8%
    11
    2.4%
    Week 97: not answered
    0
    0%
    0
    0%
    Week 113: not at all
    136
    14.6%
    31
    6.6%
    Week 113: a little
    78
    8.4%
    27
    5.8%
    Week 113: quite a bit
    30
    3.2%
    8
    1.7%
    Week 113: very much
    31
    3.3%
    7
    1.5%
    Week 113: not answered
    0
    0%
    0
    0%
    Week 129: not at all
    91
    9.8%
    18
    3.8%
    Week 129: a little
    49
    5.3%
    16
    3.4%
    Week 129: quite a bit
    27
    2.9%
    5
    1.1%
    Week 129: very much
    25
    2.7%
    2
    0.4%
    Week 129: not answered
    0
    0%
    0
    0%
    Week 145: not at all
    59
    6.3%
    9
    1.9%
    Week 145: a little
    31
    3.3%
    9
    1.9%
    Week 145: quite a bit
    18
    1.9%
    1
    0.2%
    Week 145: very much
    8
    0.9%
    2
    0.4%
    Week 145: not answered
    0
    0%
    0
    0%
    Week 161: not at all
    18
    1.9%
    2
    0.4%
    Week 161: a little
    15
    1.6%
    3
    0.6%
    Week 161: quite a bit
    3
    0.3%
    1
    0.2%
    Week 161: very much
    4
    0.4%
    2
    0.4%
    Week 161: not answered
    0
    0%
    0
    0%
    Week 177: not at all
    3
    0.3%
    0
    0%
    Week 177: a little
    3
    0.3%
    1
    0.2%
    Week 177: quite a bit
    0
    0%
    0
    0%
    Week 177: very much
    0
    0%
    0
    0%
    Week 177: not answered
    0
    0%
    0
    0%
    36. Secondary Outcome
    TitleNumber of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 50
    DescriptionThe EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 50 are reported. Question 50 was following: "To what extent were you interested in sex?"
    Time FrameBaseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified categories.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Baseline: not at all
    586
    62.8%
    291
    62.2%
    Baseline: a little
    204
    21.9%
    101
    21.6%
    Baseline: quite a bit
    67
    7.2%
    32
    6.8%
    Baseline: very much
    27
    2.9%
    15
    3.2%
    Baseline: not answered
    0
    0%
    0
    0%
    Week 17: not at all
    637
    68.3%
    293
    62.6%
    Week 17: a little
    136
    14.6%
    92
    19.7%
    Week 17: quite a bit
    45
    4.8%
    20
    4.3%
    Week 17: very much
    21
    2.3%
    14
    3%
    Week 17: not answered
    0
    0%
    0
    0%
    Week 33: not at all
    542
    58.1%
    251
    53.6%
    Week 33: a little
    136
    14.6%
    66
    14.1%
    Week 33: quite a bit
    37
    4%
    18
    3.8%
    Week 33: very much
    22
    2.4%
    6
    1.3%
    Week 33: not answered
    0
    0%
    0
    0%
    Week 49: not at all
    483
    51.8%
    180
    38.5%
    Week 49: a little
    106
    11.4%
    50
    10.7%
    Week 49: quite a bit
    33
    3.5%
    12
    2.6%
    Week 49: very much
    13
    1.4%
    8
    1.7%
    Week 49: not answered
    0
    0%
    0
    0%
    Week 65: not at all
    417
    44.7%
    143
    30.6%
    Week 65: a little
    78
    8.4%
    37
    7.9%
    Week 65: quite a bit
    27
    2.9%
    9
    1.9%
    Week 65: very much
    14
    1.5%
    4
    0.9%
    Week 65: not answered
    0
    0%
    0
    0%
    Week 81: not at all
    320
    34.3%
    114
    24.4%
    Week 81: a little
    76
    8.1%
    24
    5.1%
    Week 81: quite a bit
    26
    2.8%
    9
    1.9%
    Week 81: very much
    12
    1.3%
    1
    0.2%
    Week 81: not answered
    0
    0%
    0
    0%
    Week 97: not at all
    286
    30.7%
    65
    13.9%
    Week 97: a little
    52
    5.6%
    19
    4.1%
    Week 97: quite a bit
    20
    2.1%
    8
    1.7%
    Week 97: very much
    7
    0.8%
    3
    0.6%
    Week 97: not answered
    0
    0%
    0
    0%
    Week 113: not at all
    218
    23.4%
    59
    12.6%
    Week 113: a little
    36
    3.9%
    11
    2.4%
    Week 113: quite a bit
    14
    1.5%
    1
    0.2%
    Week 113: very much
    7
    0.8%
    2
    0.4%
    Week 113: not answered
    0
    0%
    0
    0%
    Week 129: not at all
    156
    16.7%
    33
    7.1%
    Week 129: a little
    24
    2.6%
    6
    1.3%
    Week 129: quite a bit
    9
    1%
    2
    0.4%
    Week 129: very much
    3
    0.3%
    0
    0%
    Week 129: not answered
    0
    0%
    0
    0%
    Week 145: not at all
    92
    9.9%
    14
    3%
    Week 145: a little
    16
    1.7%
    3
    0.6%
    Week 145: quite a bit
    7
    0.8%
    4
    0.9%
    Week 145: very much
    1
    0.1%
    0
    0%
    Week 145: not answered
    0
    0%
    0
    0%
    Week 161: not at all
    30
    3.2%
    5
    1.1%
    Week 161: a little
    5
    0.5%
    2
    0.4%
    Week 161: quite a bit
    4
    0.4%
    1
    0.2%
    Week 161: very much
    1
    0.1%
    0
    0%
    Week 161: not answered
    0
    0%
    0
    0%
    Week 177: not at all
    4
    0.4%
    1
    0.2%
    Week 177: a little
    1
    0.1%
    0
    0%
    Week 177: quite a bit
    1
    0.1%
    0
    0%
    Week 177: very much
    0
    0%
    0
    0%
    Week 177: not answered
    0
    0%
    0
    0%
    37. Secondary Outcome
    TitleNumber of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 51
    DescriptionThe EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 51 are reported. Question 51 was following: "To what extent were you sexually active (with or without intercourse)?"
    Time FrameBaseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified categories.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Baseline: not at all
    735
    78.8%
    374
    79.9%
    Baseline: a little
    98
    10.5%
    38
    8.1%
    Baseline: quite a bit
    41
    4.4%
    19
    4.1%
    Baseline: very much
    10
    1.1%
    8
    1.7%
    Baseline: not answered
    0
    0%
    0
    0%
    Week 17: not at all
    734
    78.7%
    354
    75.6%
    Week 17: a little
    71
    7.6%
    44
    9.4%
    Week 17: quite a bit
    24
    2.6%
    13
    2.8%
    Week 17: very much
    10
    1.1%
    8
    1.7%
    Week 17: not answered
    0
    0%
    0
    0%
    Week 33: not at all
    642
    68.8%
    299
    63.9%
    Week 33: a little
    68
    7.3%
    28
    6%
    Week 33: quite a bit
    20
    2.1%
    9
    1.9%
    Week 33: very much
    7
    0.8%
    5
    1.1%
    Week 33: not answered
    0
    0%
    0
    0%
    Week 49: not at all
    569
    61%
    214
    45.7%
    Week 49: a little
    46
    4.9%
    26
    5.6%
    Week 49: quite a bit
    15
    1.6%
    6
    1.3%
    Week 49: very much
    5
    0.5%
    4
    0.9%
    Week 49: not answered
    0
    0%
    0
    0%
    Week 65: not at all
    485
    52%
    170
    36.3%
    Week 65: a little
    37
    4%
    14
    3%
    Week 65: quite a bit
    12
    1.3%
    7
    1.5%
    Week 65: very much
    2
    0.2%
    2
    0.4%
    Week 65: not answered
    0
    0%
    0
    0%
    Week 81: not at all
    381
    40.8%
    130
    27.8%
    Week 81: a little
    32
    3.4%
    13
    2.8%
    Week 81: quite a bit
    15
    1.6%
    5
    1.1%
    Week 81: very much
    6
    0.6%
    0
    0%
    Week 81: not answered
    0
    0%
    0
    0%
    Week 97: not at all
    333
    35.7%
    79
    16.9%
    Week 97: a little
    20
    2.1%
    12
    2.6%
    Week 97: quite a bit
    9
    1%
    4
    0.9%
    Week 97: very much
    3
    0.3%
    0
    0%
    Week 97: not answered
    0
    0%
    0
    0%
    Week 113: not at all
    250
    26.8%
    68
    14.5%
    Week 113: a little
    16
    1.7%
    3
    0.6%
    Week 113: quite a bit
    6
    0.6%
    2
    0.4%
    Week 113: very much
    3
    0.3%
    0
    0%
    Week 113: not answered
    0
    0%
    0
    0%
    Week 129: not at all
    176
    18.9%
    37
    7.9%
    Week 129: a little
    8
    0.9%
    3
    0.6%
    Week 129: quite a bit
    5
    0.5%
    1
    0.2%
    Week 129: very much
    3
    0.3%
    0
    0%
    Week 129: not answered
    0
    0%
    0
    0%
    Week 145: not at all
    106
    11.4%
    17
    3.6%
    Week 145: a little
    4
    0.4%
    3
    0.6%
    Week 145: quite a bit
    5
    0.5%
    1
    0.2%
    Week 145: very much
    1
    0.1%
    0
    0%
    Week 145: not answered
    0
    0%
    0
    0%
    Week 161: not at all
    35
    3.8%
    6
    1.3%
    Week 161: a little
    3
    0.3%
    2
    0.4%
    Week 161: quite a bit
    1
    0.1%
    0
    0%
    Week 161: very much
    1
    0.1%
    0
    0%
    Week 161: not answered
    0
    0%
    0
    0%
    Week 177: not at all
    5
    0.5%
    1
    0.2%
    Week 177: a little
    0
    0%
    0
    0%
    Week 177: quite a bit
    1
    0.1%
    0
    0%
    Week 177: very much
    0
    0%
    0
    0%
    Week 177: not answered
    0
    0%
    0
    0%
    38. Secondary Outcome
    TitleNumber of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 52
    DescriptionThe EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 52 are reported. Question 52 was following: "To what extent was sex enjoyable for you?"
    Time FrameBaseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified categories.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Baseline: not at all
    5
    0.5%
    6
    1.3%
    Baseline: a little
    23
    2.5%
    11
    2.4%
    Baseline: quite a bit
    14
    1.5%
    5
    1.1%
    Baseline: very much
    8
    0.9%
    2
    0.4%
    Baseline: not answered
    0
    0%
    0
    0%
    Week 17: not at all
    7
    0.8%
    3
    0.6%
    Week 17: a little
    13
    1.4%
    9
    1.9%
    Week 17: quite a bit
    16
    1.7%
    11
    2.4%
    Week 17: very much
    3
    0.3%
    4
    0.9%
    Week 17: not answered
    800
    85.7%
    392
    83.8%
    Week 33: not at all
    8
    0.9%
    4
    0.9%
    Week 33: a little
    17
    1.8%
    8
    1.7%
    Week 33: quite a bit
    11
    1.2%
    5
    1.1%
    Week 33: very much
    4
    0.4%
    0
    0%
    Week 33: not answered
    697
    74.7%
    324
    69.2%
    Week 49: not at all
    3
    0.3%
    4
    0.9%
    Week 49: a little
    6
    0.6%
    5
    1.1%
    Week 49: quite a bit
    9
    1%
    5
    1.1%
    Week 49: very much
    3
    0.3%
    4
    0.9%
    Week 49: not answered
    614
    65.8%
    232
    49.6%
    Week 65: not at all
    4
    0.4%
    2
    0.4%
    Week 65: a little
    6
    0.6%
    4
    0.9%
    Week 65: quite a bit
    9
    1%
    4
    0.9%
    Week 65: very much
    3
    0.3%
    0
    0%
    Week 65: not answered
    514
    55.1%
    183
    39.1%
    Week 81: not at all
    5
    0.5%
    2
    0.4%
    Week 81: a little
    7
    0.8%
    3
    0.6%
    Week 81: quite a bit
    4
    0.4%
    2
    0.4%
    Week 81: very much
    5
    0.5%
    1
    0.2%
    Week 81: not answered
    413
    44.3%
    140
    29.9%
    Week 97: not at all
    2
    0.2%
    2
    0.4%
    Week 97: a little
    5
    0.5%
    0
    0%
    Week 97: quite a bit
    3
    0.3%
    3
    0.6%
    Week 97: very much
    3
    0.3%
    0
    0%
    Week 97: not answered
    352
    37.7%
    90
    19.2%
    Week 113: not at all
    0
    0%
    1
    0.2%
    Week 113: a little
    5
    0.5%
    1
    0.2%
    Week 113: quite a bit
    2
    0.2%
    0
    0%
    Week 113: very much
    2
    0.2%
    0
    0%
    Week 113: not answered
    266
    28.5%
    71
    15.2%
    Week 129: not at all
    1
    0.1%
    0
    0%
    Week 129: a little
    1
    0.1%
    0
    0%
    Week 129: quite a bit
    1
    0.1%
    0
    0%
    Week 129: very much
    1
    0.1%
    0
    0%
    Week 129: not answered
    188
    20.2%
    41
    8.8%
    Week 145: not at all
    1
    0.1%
    0
    0%
    Week 145: a little
    0
    0%
    0
    0%
    Week 145: quite a bit
    1
    0.1%
    1
    0.2%
    Week 145: very much
    0
    0%
    0
    0%
    Week 145: not answered
    114
    12.2%
    20
    4.3%
    Week 161: not at all
    1
    0.1%
    0
    0%
    Week 161: a little
    1
    0.1%
    0
    0%
    Week 161: quite a bit
    0
    0%
    0
    0%
    Week 161: very much
    0
    0%
    0
    0%
    Week 161: not answered
    38
    4.1%
    8
    1.7%
    Week 177: not at all
    0
    0%
    0
    0%
    Week 177: a little
    0
    0%
    0
    0%
    Week 177: quite a bit
    0
    0%
    0
    0%
    Week 177: very much
    0
    0%
    0
    0%
    Week 177: not answered
    6
    0.6%
    1
    0.2%
    39. Secondary Outcome
    TitleNumber of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 53
    DescriptionThe EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 53 are reported. Question 53 was following: "Did you have difficulty getting or maintaining an erection?"
    Time FrameBaseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified categories.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Baseline: not at all
    6
    0.6%
    4
    0.9%
    Baseline: a little
    19
    2%
    5
    1.1%
    Baseline: quite a bit
    4
    0.4%
    4
    0.9%
    Baseline: very much
    21
    2.3%
    11
    2.4%
    Baseline: not answered
    0
    0%
    0
    0%
    Week 17: not at all
    10
    1.1%
    8
    1.7%
    Week 17: a little
    8
    0.9%
    8
    1.7%
    Week 17: quite a bit
    8
    0.9%
    4
    0.9%
    Week 17: very much
    13
    1.4%
    7
    1.5%
    Week 17: not answered
    800
    85.7%
    392
    83.8%
    Week 33: not at all
    6
    0.6%
    2
    0.4%
    Week 33: a little
    8
    0.9%
    6
    1.3%
    Week 33: quite a bit
    8
    0.9%
    3
    0.6%
    Week 33: very much
    18
    1.9%
    6
    1.3%
    Week 33: not answered
    697
    74.7%
    324
    69.2%
    Week 49: not at all
    4
    0.4%
    6
    1.3%
    Week 49: a little
    6
    0.6%
    5
    1.1%
    Week 49: quite a bit
    0
    0%
    1
    0.2%
    Week 49: very much
    11
    1.2%
    6
    1.3%
    Week 49: not answered
    614
    65.8%
    232
    49.6%
    Week 65: not at all
    3
    0.3%
    1
    0.2%
    Week 65: a little
    4
    0.4%
    4
    0.9%
    Week 65: quite a bit
    4
    0.4%
    2
    0.4%
    Week 65: very much
    11
    1.2%
    3
    0.6%
    Week 65: not answered
    514
    55.1%
    183
    39.1%
    Week 81: not at all
    7
    0.8%
    3
    0.6%
    Week 81: a little
    2
    0.2%
    2
    0.4%
    Week 81: quite a bit
    3
    0.3%
    2
    0.4%
    Week 81: very much
    9
    1%
    1
    0.2%
    Week 81: not answered
    413
    44.3%
    140
    29.9%
    Week 97: not at all
    2
    0.2%
    1
    0.2%
    Week 97: a little
    5
    0.5%
    1
    0.2%
    Week 97: quite a bit
    1
    0.1%
    1
    0.2%
    Week 97: very much
    5
    0.5%
    2
    0.4%
    Week 97: not answered
    352
    37.7%
    90
    19.2%
    Week 113: not at all
    1
    0.1%
    0
    0%
    Week 113: a little
    3
    0.3%
    1
    0.2%
    Week 113: quite a bit
    1
    0.1%
    0
    0%
    Week 113: very much
    4
    0.4%
    1
    0.2%
    Week 113: not answered
    266
    28.5%
    71
    15.2%
    Week 129: not at all
    0
    0%
    0
    0%
    Week 129: a little
    1
    0.1%
    0
    0%
    Week 129: quite a bit
    0
    0%
    0
    0%
    Week 129: very much
    3
    0.3%
    0
    0%
    Week 129: not answered
    188
    20.2%
    41
    8.8%
    Week 145: not at all
    1
    0.1%
    0
    0%
    Week 145: a little
    0
    0%
    1
    0.2%
    Week 145: quite a bit
    0
    0%
    0
    0%
    Week 145: very much
    1
    0.1%
    0
    0%
    Week 145: not answered
    114
    12.2%
    20
    4.3%
    Week 161: not at all
    1
    0.1%
    0
    0%
    Week 161: a little
    0
    0%
    0
    0%
    Week 161: quite a bit
    1
    0.1%
    0
    0%
    Week 161: very much
    0
    0%
    0
    0%
    Week 161: not answered
    38
    4.1%
    8
    1.7%
    Week 177: not at all
    0
    0%
    0
    0%
    Week 177: a little
    0
    0%
    0
    0%
    Week 177: quite a bit
    0
    0%
    0
    0%
    Week 177: very much
    0
    0%
    0
    0%
    Week 177: not answered
    6
    0.6%
    1
    0.2%
    40. Secondary Outcome
    TitleNumber of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 54
    DescriptionThe EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 54 are reported. Question 54 was following: "Did you have ejaculation problems (e.g, dry ejaculation)?"
    Time FrameBaseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified categories.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Baseline: not at all
    11
    1.2%
    7
    1.5%
    Baseline: a little
    14
    1.5%
    4
    0.9%
    Baseline: quite a bit
    3
    0.3%
    2
    0.4%
    Baseline: very much
    22
    2.4%
    11
    2.4%
    Baseline: not answered
    0
    0%
    0
    0%
    Week 17: not at all
    13
    1.4%
    11
    2.4%
    Week 17: a little
    5
    0.5%
    5
    1.1%
    Week 17: quite a bit
    3
    0.3%
    1
    0.2%
    Week 17: very much
    18
    1.9%
    10
    2.1%
    Week 17: not answered
    800
    85.7%
    392
    83.8%
    Week 33: not at all
    12
    1.3%
    10
    2.1%
    Week 33: a little
    9
    1%
    1
    0.2%
    Week 33: quite a bit
    5
    0.5%
    0
    0%
    Week 33: very much
    14
    1.5%
    6
    1.3%
    Week 33: not answered
    697
    74.7%
    324
    69.2%
    Week 49: not at all
    7
    0.8%
    6
    1.3%
    Week 49: a little
    3
    0.3%
    5
    1.1%
    Week 49: quite a bit
    1
    0.1%
    1
    0.2%
    Week 49: very much
    10
    1.1%
    6
    1.3%
    Week 49: not answered
    614
    65.8%
    232
    49.6%
    Week 65: not at all
    8
    0.9%
    3
    0.6%
    Week 65: a little
    2
    0.2%
    1
    0.2%
    Week 65: quite a bit
    1
    0.1%
    2
    0.4%
    Week 65: very much
    11
    1.2%
    4
    0.9%
    Week 65: not answered
    514
    55.1%
    183
    39.1%
    Week 81: not at all
    7
    0.8%
    4
    0.9%
    Week 81: a little
    0
    0%
    0
    0%
    Week 81: quite a bit
    3
    0.3%
    0
    0%
    Week 81: very much
    11
    1.2%
    4
    0.9%
    Week 81: not answered
    413
    44.3%
    140
    29.9%
    Week 97: not at all
    5
    0.5%
    2
    0.4%
    Week 97: a little
    3
    0.3%
    0
    0%
    Week 97: quite a bit
    0
    0%
    1
    0.2%
    Week 97: very much
    5
    0.5%
    2
    0.4%
    Week 97: not answered
    352
    37.7%
    90
    19.2%
    Week 113: not at all
    3
    0.3%
    2
    0.4%
    Week 113: a little
    1
    0.1%
    0
    0%
    Week 113: quite a bit
    0
    0%
    0
    0%
    Week 113: very much
    5
    0.5%
    0
    0%
    Week 113: not answered
    266
    28.5%
    71
    15.2%
    Week 129: not at all
    1
    0.1%
    0
    0%
    Week 129: a little
    0
    0%
    0
    0%
    Week 129: quite a bit
    0
    0%
    0
    0%
    Week 129: very much
    3
    0.3%
    0
    0%
    Week 129: not answered
    188
    20.2%
    41
    8.8%
    Week 145: not at all
    2
    0.2%
    0
    0%
    Week 145: a little
    0
    0%
    1
    0.2%
    Week 145: quite a bit
    0
    0%
    0
    0%
    Week 145: very much
    0
    0%
    0
    0%
    Week 145: not answered
    114
    12.2%
    20
    4.3%
    Week 161: not at all
    1
    0.1%
    0
    0%
    Week 161: a little
    0
    0%
    0
    0%
    Week 161: quite a bit
    1
    0.1%
    0
    0%
    Week 161: very much
    0
    0%
    0
    0%
    Week 161: not answered
    38
    4.1%
    8
    1.7%
    Week 177: not at all
    0
    0%
    0
    0%
    Week 177: a little
    0
    0%
    0
    0%
    Week 177: quite a bit
    0
    0%
    0
    0%
    Week 177: very much
    0
    0%
    0
    0%
    Week 177: not answered
    6
    0.6%
    1
    0.2%
    41. Secondary Outcome
    TitleNumber of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 55
    DescriptionThe EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 55 are reported. Question 55 was following: "Have you felt uncomfortable about being sexually intimate?"
    Time FrameBaseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

    Outcome Measure Data

    Analysis Population Description
    The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified categories.
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants933468
    Baseline: not at all
    31
    3.3%
    13
    2.8%
    Baseline: a little
    13
    1.4%
    8
    1.7%
    Baseline: quite a bit
    4
    0.4%
    0
    0%
    Baseline: very much
    2
    0.2%
    3
    0.6%
    Baseline: not answered
    0
    0%
    0
    0%
    Week 17: not at all
    23
    2.5%
    14
    3%
    Week 17: a little
    11
    1.2%
    7
    1.5%
    Week 17: quite a bit
    2
    0.2%
    3
    0.6%
    Week 17: very much
    3
    0.3%
    3
    0.6%
    Week 17: not answered
    800
    85.7%
    392
    83.8%
    Week 33: not at all
    24
    2.6%
    10
    2.1%
    Week 33: a little
    6
    0.6%
    4
    0.9%
    Week 33: quite a bit
    6
    0.6%
    2
    0.4%
    Week 33: very much
    4
    0.4%
    1
    0.2%
    Week 33: not answered
    697
    74.7%
    324
    69.2%
    Week 49: not at all
    16
    1.7%
    10
    2.1%
    Week 49: a little
    4
    0.4%
    6
    1.3%
    Week 49: quite a bit
    1
    0.1%
    1
    0.2%
    Week 49: very much
    0
    0%
    1
    0.2%
    Week 49: not answered
    614
    65.8%
    232
    49.6%
    Week 65: not at all
    13
    1.4%
    5
    1.1%
    Week 65: a little
    7
    0.8%
    3
    0.6%
    Week 65: quite a bit
    1
    0.1%
    2
    0.4%
    Week 65: very much
    1
    0.1%
    0
    0%
    Week 65: not answered
    514
    55.1%
    183
    39.1%
    Week 81: not at all
    13
    1.4%
    5
    1.1%
    Week 81: a little
    6
    0.6%
    1
    0.2%
    Week 81: quite a bit
    1
    0.1%
    1
    0.2%
    Week 81: very much
    1
    0.1%
    1
    0.2%
    Week 81: not answered
    413
    44.3%
    140
    29.9%
    Week 97: not at all
    8
    0.9%
    3
    0.6%
    Week 97: a little
    3
    0.3%
    2
    0.4%
    Week 97: quite a bit
    1
    0.1%
    0
    0%
    Week 97: very much
    1
    0.1%
    0
    0%
    Week 97: not answered
    352
    37.7%
    90
    19.2%
    Week 113: not at all
    7
    0.8%
    2
    0.4%
    Week 113: a little
    0
    0%
    0
    0%
    Week 113: quite a bit
    1
    0.1%
    0
    0%
    Week 113: very much
    1
    0.1%
    0
    0%
    Week 113: not answered
    266
    28.5%
    71
    15.2%
    Week 129: not at all
    3
    0.3%
    0
    0%
    Week 129: a little
    0
    0%
    0
    0%
    Week 129: quite a bit
    1
    0.1%
    0
    0%
    Week 129: very much
    0
    0%
    0
    0%
    Week 129: not answered
    188
    20.2%
    41
    8.8%
    Week 145: not at all
    2
    0.2%
    1
    0.2%
    Week 145: a little
    0
    0%
    0
    0%
    Week 145: quite a bit
    0
    0%
    0
    0%
    Week 145: very much
    0
    0%
    0
    0%
    Week 145: not answered
    114
    12.2%
    20
    4.3%
    Week 161: not at all
    1
    0.1%
    0
    0%
    Week 161: a little
    0
    0%
    0
    0%
    Week 161: quite a bit
    1
    0.1%
    0
    0%
    Week 161: very much
    0
    0%
    0
    0%
    Week 161: not answered
    38
    4.1%
    8
    1.7%
    Week 177: not at all
    0
    0%
    0
    0%
    Week 177: a little
    0
    0%
    0
    0%
    Week 177: quite a bit
    0
    0%
    0
    0%
    Week 177: very much
    0
    0%
    0
    0%
    Week 177: not answered
    6
    0.6%
    1
    0.2%
    42. Secondary Outcome
    TitleNumber of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
    DescriptionAn AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment-emergent AE (TEAE) was defined as an AE that occurred from the date and time of the first dose of study drug through the date of last dose +30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first). AEs included both non-serious adverse events (AEs) and SAEs.
    Time FrameFrom first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)

    Outcome Measure Data

    Analysis Population Description
    The safety population was defined as all participants randomly assigned to receive at least 1 dose or partial dose of study drug (enzalutamide or placebo) according to the actual treatment received (not the treatment assigned).
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants930465
    AEs
    808
    86.6%
    360
    76.9%
    SAEs
    226
    24.2%
    85
    18.2%
    43. Secondary Outcome
    TitleNumber of Participants With Treatment-Emergent Adverse Events Greater Than or Equal to Grade 3, Based on National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE), Version 4.0
    DescriptionAn AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. As per NCI CTCAE, Grade 3 events =medically significant but not immediately life-threatening, unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment, Grade 4 events =participant to be in imminent danger of death. Grade 5 events =death. A treatment-emergent AE (TEAE) was defined as an AE that occurred from the date and time of the first dose of study drug through the date of last dose +30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first).Number of participants with AEs of any of the Grade 3 or above (Grade 4, 5) were reported.
    Time FrameFrom first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)

    Outcome Measure Data

    Analysis Population Description
    The safety population was defined as all participants randomly assigned to receive at least 1 dose or partial dose of study drug (enzalutamide or placebo) according to the actual treatment received (not the treatment assigned).
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants930465
    Count of Participants [Participants]
    292
    31.3%
    109
    23.3%
    44. Secondary Outcome
    TitleNumber of Participants With Discontinuations From Study Treatment Due to Adverse Events (AEs)
    DescriptionAn AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both non-serious adverse events (AEs) and SAEs.
    Time FrameFrom first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)

    Outcome Measure Data

    Analysis Population Description
    The safety population was defined as all participants randomly assigned to receive at least 1 dose or partial dose of study drug (enzalutamide or placebo) according to the actual treatment received (not the treatment assigned).
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants930465
    Count of Participants [Participants]
    87
    9.3%
    28
    6%
    45. Secondary Outcome
    TitleNumber of Participants With Increase of 2 or More National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) (Version 4.0) Toxicity Grades Above Baseline - Hematology
    DescriptionHematology parameters: Haemoglobin (grams per liter [g/L]); leukocytes (log 10 raised to power 9 per liter [10*9/L]); lymphocytes (log 10 raised to power 6 per liter [10*6/L]); neutrophils (log 10 raised to power 6 per liter [10*6/L]); platelets (log 10 raised to power 9 per litre [10*9/L]).
    Time FrameFrom first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)

    Outcome Measure Data

    Analysis Population Description
    The safety population was defined as all participants randomly assigned to receive at least 1 dose or partial dose of study drug (enzalutamide or placebo) according to the actual treatment received (not the treatment assigned).
    Arm/Group TitleEnzalutamide 160 mgPlacebo
    Arm/Group DescriptionParticipants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    Measure Participants930465
    Haemoglobin (Low)
    12
    1.3%
    7
    1.5%
    Leukocytes (Low)
    7
    0.8%
    7
    1.5%
    Lymphocytes (High)