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Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00887198
Collaborator
(none)
1,088
Enrollment
135
Locations
2
Arms
96.9
Actual Duration (Months)
8.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer (CRPC).

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

This is a randomized (individuals will be assigned by chance to study treatments), double-blind (individuals and study personnel will not know the identity of study treatments), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study in approximately 1,000 medically or surgically castrated male patients with metastatic CRPC who have shown tumor progression and are asymptomatic or mildly symptomatic. The study period will consist of screening, treatment, and follow-up phases. Patients will receive study treatment (abiraterone acetate or placebo) plus prednisone until radiographic progression of disease and/or unequivocal clinical progression. Efficacy evaluations will be performed throughout the treatment period and safety will be assessed until 30 days after the last dose of abiraterone acetate. throughout the study. Follow-up will continue for up to 60 months (5 years) or until the patient dies, is lost to follow-up, or withdraws informed consent. At the interim analysis of overall survival (OS; 43% of death events), the independent data monitoring committee (IDMC) reviewed the efficacy and safety data and concluded that all of the data pointed to a significant advantage for patients in one arm of the study compared with the other arm thereby unanimously recommending unblinding the study and allowing crossover from the placebo arm to active therapy. Patients currently receiving placebo will be offered crossover therapy to abiraterone acetate. Treatment for patients who were originally randomized to the abiraterone acetate treatment group will not change. Patients will be discontinued from long term follow-up at the time of the Clinical Cut-Off Date for Final Analysis (CCO-FA); however, patients still receiving treatment with abiraterone acetate at the CCO-FA will be offered to receive continued treatment for an additional period of up to 3 years or until disease progression or unacceptable toxicity. For these patients, safety assessment will be performed while continuing treatment, and for 30 days after the last dose of abiraterone acetate.

Study Design

Study Type:
Interventional
Actual Enrollment :
1088 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
Actual Study Start Date :
Apr 28, 2009
Actual Primary Completion Date :
Mar 31, 2014
Actual Study Completion Date :
May 25, 2017

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo + prednisone

Placebo plus prednisone

Drug: Placebo
4 placebo tablets per day taken orally.

Drug: Prednisone
5 mg tablet orally twice daily.
Experimental: Abiraterone + prednisone

Abiraterone acetate plus prednisone

Drug: Abiraterone acetate
1000 mg per day (4 x 250-mg tablets) taken orally.

Drug: Prednisone
5 mg tablet orally twice daily.

Outcome Measures

Primary Outcome Measures

  1. Overall Survival [From randomization (Day 1) up to end of study (Month 60)]

    Overall survival is defined as the time from randomization to date of death from any cause.

  2. Radiographic Progression-free Survival (rPFS) [From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)]

    The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (>=) 2 new lesions compared to baseline was observed in less than (<) 12 weeks from randomization and was confirmed by a second bone scan taken >=6 weeks later showing >=2 additional new lesions (a total of >=4 new lesions compared to baseline), b) the first bone scan with >=2 new lesions compared to baseline was observed in >=12 weeks from randomization and the new lesions were verified on the next bone scan >=6 weeks later (a total of >=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI); 3) death from any cause.

Secondary Outcome Measures

  1. Time to Opiate Use for Prostate Cancer Pain [From randomization (Day 1) up to first opiate use or end of study (Month 60)]

    The time interval from the date of randomization to the date of opiate use for cancer pain. Participants who have no opiate use at the time of analysis were censored at the last known date of no opiate use for cancer pain. Participants with no assessment were censored at the date of randomization.

  2. Time to Initiation of Cytotoxic Chemotherapy [From randomization (Day 1) up to initiation of cytotoxic chemotherapy or cutoff date (Month 18)]

    The time interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer. Participants who had no cytotoxic chemotherapy administration at the time of analysis were censored at the last known date when no cytotoxic chemotherapy was administered. Participants with no assessment were censored at the date of randomization.

  3. Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by >=1 Point [From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)]

    The time interval from the date of randomization to the first date at which there was at least a 1 grade change (worsening) in the ECOG performance status grade. Participants who had no deterioration in ECOG performance status grade at the time of the analysis were censored at the last known date of no deterioration. ECOG is a 5-point scale, where 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all self-care, 3=Capable of limited self-care, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no self-care, totally confined to bed or chair, 5=Dead. Participants with no assessment were censored at the date of randomization.

  4. Time to Prostate-specific Antigen (PSA) Progression [From randomization (Day 1) up to date of PSA progerssion or cutoff date (Month 18)]

    The time interval from the date of randomization to the date of PSA progression as defined in the protocol-specific prostate cancer Working Group 2 (PCWG2) criteria. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase from nadir and an absolute increase of 2 nanogram/milliliter ((ng/mL) or more, which is confirmed by a second value obtained in 3 or more weeks. Participants who had no PSA progression at the time of the analysis were censored at the last known date of no PSA progression. Participants with no on-study PSA assessment or no baseline PSA assessment were censored at the date of randomization.

  5. Number of Participants With Treatment Emergent Adverse Events [From first dose of study drug up to 30 days after the last dose of study drug]

    An adverse event (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. Treatment-emergent were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.

  6. Mean Plasma Concentrations of Abiraterone [Up to Cycle 5, Day 1]

  7. Maximum Plasma Concentrations of Abiraterone [Up to Cycle 5, Day 1]

  8. Area Under the Plasma Concentration-time Curve From Time 0 to Time the Last Quantifiable Concentration of Abiraterone (AUC[0-infinity]) [Up to Cycle 5, Day 1]

    The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.

  9. Elimination Half-Life (t1/2) [Up to Cycle 5, Day 1]

    The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Metastatic castration-resistant prostate cancer (CRPC)

  • Previous anti-androgen therapy and progression after withdrawal

  • ECOG performance status of either 0 or 1

  • Medical or surgical castration with testosterone less than 50 ng/dL

  • Life expectancy of at least 6 months

Exclusion Criteria:

  • Prior cytotoxic chemotherapy or biologic therapy for CRPC

  • Prior ketoconazole for prostate cancer

  • Known brain metastasis or visceral organ metastasis

  • Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime within 4 weeks of Cycle 1 Day 1

Contacts and Locations

Locations

Site City State Country Postal Code
1 Birmingham Alabama United States
2 Tucson Arizona United States
3 Bellflower California United States
4 Los Angeles California United States
5 Marina Del Rey California United States
6 Sacramento California United States
7 San Diego California United States
8 San Francisco California United States
9 Stanford California United States
10 Aurora Colorado United States
11 New Haven Connecticut United States
12 Boca Raton Florida United States
13 Fort Myers Florida United States
14 Gainesville Florida United States
15 Atlanta Georgia United States
16 Honolulu Hawaii United States
17 Kansas City Kansas United States
18 Metairie Louisiana United States
19 New Orleans Louisiana United States
20 Baltimore Maryland United States
21 Boston Massachusetts United States
22 Dearborn Michigan United States
23 Saint Louis Park Minnesota United States
24 Saint Louis Missouri United States
25 Billings Montana United States
26 Omaha Nebraska United States
27 Las Vegas Nevada United States
28 East Syracuse New York United States
29 New Hyde Park New York United States
30 New York New York United States
31 Syracuse New York United States
32 Durham North Carolina United States
33 Raleigh North Carolina United States
34 Canton Ohio United States
35 Cleveland Ohio United States
36 Portland Oregon United States
37 Philadelphia Pennsylvania United States
38 Pittsburgh Pennsylvania United States
39 Columbia South Carolina United States
40 Myrtle Beach South Carolina United States
41 Chattanooga Tennessee United States
42 Nashville Tennessee United States
43 Dallas Texas United States
44 Houston Texas United States
45 San Antonio Texas United States
46 Norfolk Virginia United States
47 Seattle Washington United States
48 Madison Wisconsin United States
49 Adelaide Australia
50 Camperdown Australia
51 Footscray Australia
52 Frankston Australia
53 Garran Australia
54 Geelong Australia
55 Heidelberg Australia
56 Herston Australia
57 Hornsby Australia
58 Kogarah Australia
59 Kurralta Park Australia
60 Lismore Australia
61 Liverpool Australia
62 Malvern Australia
63 Parkville Australia
64 Perth Australia
65 South Brisbane Australia
66 Southport Australia
67 Subiaco Australia
68 Aalst Belgium
69 Antwerpen Belgium
70 Gent Belgium
71 Hasselt Belgium
72 Leuven Belgie Belgium
73 Roeselare Belgium
74 Calgary Alberta Canada
75 Edmonton Alberta Canada
76 Kelowna British Columbia Canada
77 Vancouver British Columbia Canada
78 Victoria British Columbia Canada
79 Hamilton Ontario Canada
80 London Ontario Canada
81 Toronto Ontario Canada
82 Montreal Quebec Canada
83 London Canada
84 Quebec Canada
85 Caen France
86 Clichy France
87 Dijon Cedex France
88 La Roche Sur Yon France
89 Lyon Cedex 03 France
90 Lyon France
91 Montpellier France
92 Paris Cedex 15 France
93 Tours, Cedex 9 France
94 Villejuif France
95 Aachen Germany
96 Berlin Germany
97 Braunschweig Germany
98 Dresden Germany
99 Düsseldorf Germany
100 Hamburg Germany
101 Hannover Germany
102 Homburg Germany
103 Kempen Germany
104 Leipzig Germany
105 Muenchen Germany
106 Münster Germany
107 Wuppertal Germany
108 Athens Greece
109 Larisa Greece
110 Amsterdam Netherlands
111 Heerlen Netherlands
112 Nijmegen Netherlands
113 Rotterdam Netherlands
114 Barcelona Spain
115 Coruña Spain
116 Madrid Spain
117 Oviedo Spain
118 Santander N/A Spain
119 Santiago De Compostela Spain
120 Göteborg Sweden
121 Malmö N/A Sweden
122 Stockholm Sweden
123 Uppsala Sweden
124 Växjö Sweden
125 Birmingham United Kingdom
126 Cambridge United Kingdom
127 Glasgow United Kingdom
128 Leeds United Kingdom
129 London United Kingdom
130 Manchester United Kingdom
131 Newcastle Upon Tyne United Kingdom
132 Oxford United Kingdom
133 Sutton United Kingdom
134 Whitchurch United Kingdom
135 Wirral United Kingdom

Sponsors and Collaborators

  • Janssen Research & Development, LLC

Investigators

  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00887198
Other Study ID Numbers:
  • CR016927
  • COU-AA-302
  • 2008-008004-41
First Posted:
Apr 23, 2009
Last Update Posted:
Jun 25, 2018
Last Verified:
May 1, 2018
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Janssen Research & Development, LLC
Prostate cancer
Abiraterone acetate
CB7630
CRPC
Metastatic castration-resistant prostate cancer
hormone refractory prostate cancer
Additional relevant MeSH terms:
Prostatic Neoplasms
Prednisone
Abiraterone Acetate

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Abiraterone Acetate + Prednisone (AAP) Placebo Placebo to AA
Arm/Group Description Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression. Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression. Participants who were originally assigned to placebo were later on switched to 1,000 milligram (mg) abiraterone acetate tablet (as 4*250 mg tablets) along with prednisone 5 mg tablet.
Period Title: Randomized Period
STARTED 546 542 0
Treated 542 540 0
COMPLETED 0 0 0
NOT COMPLETED 546 542 0
Period Title: Randomized Period
STARTED 0 0 93
COMPLETED 0 0 0
NOT COMPLETED 0 0 93

Baseline Characteristics

Arm/Group Title Abiraterone Acetate + Prednisone (AAP) Placebo Total
Arm/Group Description Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression. Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression. Total of all reporting groups
Overall Participants 546 542 1088
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
70.5
(8.8)
70.1
(8.72)
70.3
(8.76)
Sex: Female, Male (Count of Participants)
Female
0
0%
0
0%
0
0%
Male
546
100%
542
100%
1088
100%
Region of Enrollment (Count of Participants)
Australia
60
11%
72
13.3%
132
12.1%
Belgium
25
4.6%
17
3.1%
42
3.9%
Canada
63
11.5%
37
6.8%
100
9.2%
France
24
4.4%
29
5.4%
53
4.9%
Germany
46
8.4%
32
5.9%
78
7.2%
Greece
7
1.3%
7
1.3%
14
1.3%
Italy
1
0.2%
6
1.1%
7
0.6%
Netherlands
15
2.7%
15
2.8%
30
2.8%
Spain
25
4.6%
20
3.7%
45
4.1%
Sweden
4
0.7%
13
2.4%
17
1.6%
United Kingdom
42
7.7%
56
10.3%
98
9%
United States
234
42.9%
238
43.9%
472
43.4%

Outcome Measures

1. Primary Outcome
Title Overall Survival
Description Overall survival is defined as the time from randomization to date of death from any cause.
Time Frame From randomization (Day 1) up to end of study (Month 60)

Outcome Measure Data

Analysis Population Description
Intent-to-treat (ITT) population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.
Arm/Group Title Abiraterone Acetate + Prednisone (AAP) Placebo
Arm/Group Description Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression. Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
Measure Participants 546 542
Median (95% Confidence Interval) [Months]
34.66
30.29
2. Primary Outcome
Title Radiographic Progression-free Survival (rPFS)
Description The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (>=) 2 new lesions compared to baseline was observed in less than (<) 12 weeks from randomization and was confirmed by a second bone scan taken >=6 weeks later showing >=2 additional new lesions (a total of >=4 new lesions compared to baseline), b) the first bone scan with >=2 new lesions compared to baseline was observed in >=12 weeks from randomization and the new lesions were verified on the next bone scan >=6 weeks later (a total of >=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI); 3) death from any cause.
Time Frame From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)

Outcome Measure Data

Analysis Population Description
ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.
Arm/Group Title Abiraterone Acetate + Prednisone (AAP) Placebo
Arm/Group Description Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression. Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
Measure Participants 546 542
Median (95% Confidence Interval) [Months]
NA
8.28
3. Secondary Outcome
Title Time to Opiate Use for Prostate Cancer Pain
Description The time interval from the date of randomization to the date of opiate use for cancer pain. Participants who have no opiate use at the time of analysis were censored at the last known date of no opiate use for cancer pain. Participants with no assessment were censored at the date of randomization.
Time Frame From randomization (Day 1) up to first opiate use or end of study (Month 60)

Outcome Measure Data

Analysis Population Description
ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.
Arm/Group Title Abiraterone Acetate + Prednisone (AAP) Placebo
Arm/Group Description Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression. Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
Measure Participants 546 542
Median (95% Confidence Interval) [Months]
33.38
23.39
4. Secondary Outcome
Title Time to Initiation of Cytotoxic Chemotherapy
Description The time interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer. Participants who had no cytotoxic chemotherapy administration at the time of analysis were censored at the last known date when no cytotoxic chemotherapy was administered. Participants with no assessment were censored at the date of randomization.
Time Frame From randomization (Day 1) up to initiation of cytotoxic chemotherapy or cutoff date (Month 18)

Outcome Measure Data

Analysis Population Description
ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.
Arm/Group Title Abiraterone Acetate + Prednisone (AAP) Placebo
Arm/Group Description Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression. Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
Measure Participants 546 542
Median (95% Confidence Interval) [Months]
25.17
16.82
5. Secondary Outcome
Title Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by >=1 Point
Description The time interval from the date of randomization to the first date at which there was at least a 1 grade change (worsening) in the ECOG performance status grade. Participants who had no deterioration in ECOG performance status grade at the time of the analysis were censored at the last known date of no deterioration. ECOG is a 5-point scale, where 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all self-care, 3=Capable of limited self-care, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no self-care, totally confined to bed or chair, 5=Dead. Participants with no assessment were censored at the date of randomization.
Time Frame From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)

Outcome Measure Data

Analysis Population Description
ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.
Arm/Group Title Abiraterone Acetate + Prednisone (AAP) Placebo
Arm/Group Description Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression. Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
Measure Participants 546 542
Median (95% Confidence Interval) [Months]
12.29
10.87
6. Secondary Outcome
Title Time to Prostate-specific Antigen (PSA) Progression
Description The time interval from the date of randomization to the date of PSA progression as defined in the protocol-specific prostate cancer Working Group 2 (PCWG2) criteria. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase from nadir and an absolute increase of 2 nanogram/milliliter ((ng/mL) or more, which is confirmed by a second value obtained in 3 or more weeks. Participants who had no PSA progression at the time of the analysis were censored at the last known date of no PSA progression. Participants with no on-study PSA assessment or no baseline PSA assessment were censored at the date of randomization.
Time Frame From randomization (Day 1) up to date of PSA progerssion or cutoff date (Month 18)

Outcome Measure Data

Analysis Population Description
ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.
Arm/Group Title Abiraterone Acetate + Prednisone (AAP) Placebo
Arm/Group Description Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression. Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
Measure Participants 546 542
Median (95% Confidence Interval) [Months]
11.07
5.55
7. Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events
Description An adverse event (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. Treatment-emergent were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.
Time Frame From first dose of study drug up to 30 days after the last dose of study drug

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants in the randomized population who received any study drug.
Arm/Group Title Abiraterone Acetate + Prednisone (AAP) Placebo Placebo to Abiraterone Acetate
Arm/Group Description Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression. Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression. Participants received initially placebo along with prednisone 5 mg tablet, orally, later on switched to 1,000 milligram (mg) abiraterone acetate tablet (as 4*250 mg tablets) along with prednisone 5 mg tablet due to disease progression.
Measure Participants 542 540 93
With Treatment-Emergent Adverse Events
541
99.1%
524
96.7%
93
8.5%
With Treatment-Emergent Serious Adverse Events
208
38.1%
148
27.3%
39
3.6%
8. Secondary Outcome
Title Mean Plasma Concentrations of Abiraterone
Description
Time Frame Up to Cycle 5, Day 1

Outcome Measure Data

Analysis Population Description
Data was not reported as non-compartmental analysis was not performed due to sparse sampling.
Arm/Group Title Abiraterone Acetate + Prednisone (AAP) Placebo
Arm/Group Description Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression. Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
Measure Participants 0 0
9. Secondary Outcome
Title Maximum Plasma Concentrations of Abiraterone
Description
Time Frame Up to Cycle 5, Day 1

Outcome Measure Data

Analysis Population Description
Data was not reported as non-compartmental analysis was not performed due to sparse sampling.
Arm/Group Title Abiraterone Acetate + Prednisone (AAP) Placebo
Arm/Group Description Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression. Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
Measure Participants 0 0
10. Secondary Outcome
Title Area Under the Plasma Concentration-time Curve From Time 0 to Time the Last Quantifiable Concentration of Abiraterone (AUC[0-infinity])
Description The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Time Frame Up to Cycle 5, Day 1

Outcome Measure Data

Analysis Population Description
Data was not reported as non-compartmental analysis was not performed due to sparse sampling.
Arm/Group Title Abiraterone Acetate + Prednisone (AAP) Placebo
Arm/Group Description Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression. Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
Measure Participants 0 0
11. Secondary Outcome
Title Elimination Half-Life (t1/2)
Description The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Time Frame Up to Cycle 5, Day 1

Outcome Measure Data

Analysis Population Description
Data was not reported as non-compartmental analysis was not performed due to sparse sampling.
Arm/Group Title Abiraterone Acetate + Prednisone (AAP) Placebo
Arm/Group Description Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression. Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
Measure Participants 0 0

Adverse Events

Time Frame From first dose of study drug up to 30 days after the last dose of study drug (Approximately 5 years)
Adverse Event Reporting Description Safety analysis set included all participants in the randomized population who received any study drug.
Arm/Group Title Abiraterone Acetate + Prednisone (AAP) Placebo Placebo to AA
Arm/Group Description Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression. Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression. Participants who were originally assigned to placebo were later on switched to 1,000 milligram (mg) abiraterone acetate tablet (as 4*250 mg tablets) along with prednisone 5 mg tablet.
All Cause Mortality
Abiraterone Acetate + Prednisone (AAP) Placebo Placebo to AA
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN)
Serious Adverse Events
Abiraterone Acetate + Prednisone (AAP) Placebo Placebo to AA
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 215/542 (39.7%) 156/540 (28.9%) 40/93 (43%)
Blood and lymphatic system disorders
Anaemia 8/542 (1.5%) 6/540 (1.1%) 1/93 (1.1%)
Coagulopathy 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Leukocytosis 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Lymphopenia 0/542 (0%) 0/540 (0%) 1/93 (1.1%)
Thrombocytopenia 1/542 (0.2%) 1/540 (0.2%) 1/93 (1.1%)
Disseminated Intravascular Coagulation 1/542 (0.2%) 0/540 (0%) 1/93 (1.1%)
Febrile Neutropenia 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Cardiac disorders
Tachyarrhythmia 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Acute Coronary Syndrome 0/542 (0%) 0/540 (0%) 1/93 (1.1%)
Acute Myocardial Infarction 1/542 (0.2%) 0/540 (0%) 1/93 (1.1%)
Angina Pectoris 6/542 (1.1%) 1/540 (0.2%) 0/93 (0%)
Atrial Fibrillation 11/542 (2%) 8/540 (1.5%) 0/93 (0%)
Atrioventricular Block 1/542 (0.2%) 1/540 (0.2%) 0/93 (0%)
Atrioventricular Block Second Degree 1/542 (0.2%) 0/540 (0%) 1/93 (1.1%)
Bifascicular Block 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Cardiac Arrest 1/542 (0.2%) 2/540 (0.4%) 0/93 (0%)
Cardiac Disorder 1/542 (0.2%) 1/540 (0.2%) 0/93 (0%)
Cardiac Failure 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Cardiac Failure Congestive 3/542 (0.6%) 0/540 (0%) 0/93 (0%)
Conduction Disorder 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Coronary Artery Disease 4/542 (0.7%) 1/540 (0.2%) 0/93 (0%)
Ischaemic Cardiomyopathy 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Myocardial Infarction 4/542 (0.7%) 5/540 (0.9%) 2/93 (2.2%)
Myocardial Ischaemia 2/542 (0.4%) 0/540 (0%) 0/93 (0%)
Supraventricular Tachyarrhythmia 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Supraventricular Tachycardia 2/542 (0.4%) 0/540 (0%) 1/93 (1.1%)
Ear and labyrinth disorders
Hypoacusis 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Vertigo 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Endocrine disorders
Adrenal Insufficiency 2/542 (0.4%) 0/540 (0%) 0/93 (0%)
Gastrointestinal disorders
Colitis 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Constipation 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Diarrhoea 2/542 (0.4%) 0/540 (0%) 1/93 (1.1%)
Dyspepsia 1/542 (0.2%) 1/540 (0.2%) 0/93 (0%)
Gastritis 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Ileus 2/542 (0.4%) 1/540 (0.2%) 0/93 (0%)
Melaena 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Nausea 2/542 (0.4%) 0/540 (0%) 1/93 (1.1%)
Pancreatitis 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Periodontitis 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Peritonitis 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Vomiting 2/542 (0.4%) 0/540 (0%) 0/93 (0%)
Abdominal Pain 3/542 (0.6%) 5/540 (0.9%) 0/93 (0%)
Abdominal Pain Lower 1/542 (0.2%) 1/540 (0.2%) 0/93 (0%)
Abdominal Pain Upper 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Diverticular Perforation 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Diverticulum Intestinal 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Diverticulum Intestinal Haemorrhagic 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Enterovesical Fistula 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Food Poisoning 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Gastric Ulcer 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Gastritis Erosive 0/542 (0%) 0/540 (0%) 1/93 (1.1%)
Gastrointestinal Haemorrhage 1/542 (0.2%) 1/540 (0.2%) 0/93 (0%)
Gastrointestinal Necrosis 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Gastrooesophageal Reflux Disease 2/542 (0.4%) 1/540 (0.2%) 0/93 (0%)
Intestinal Ischaemia 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Intestinal Obstruction 2/542 (0.4%) 0/540 (0%) 0/93 (0%)
Oesophageal Mass 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Pancreatic Disorder 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Pancreatitis Necrotising 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Small Intestinal Obstruction 2/542 (0.4%) 0/540 (0%) 0/93 (0%)
Upper Gastrointestinal Haemorrhage 0/542 (0%) 0/540 (0%) 1/93 (1.1%)
Varices Oesophageal 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
General disorders
Asthenia 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Fatigue 2/542 (0.4%) 0/540 (0%) 2/93 (2.2%)
Malaise 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Pain 0/542 (0%) 1/540 (0.2%) 1/93 (1.1%)
Pyrexia 3/542 (0.6%) 3/540 (0.6%) 0/93 (0%)
Catheter Related Complication 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Chest Pain 0/542 (0%) 1/540 (0.2%) 1/93 (1.1%)
Death 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Disease Progression 8/542 (1.5%) 4/540 (0.7%) 6/93 (6.5%)
Gait Disturbance 1/542 (0.2%) 1/540 (0.2%) 0/93 (0%)
General Physical Health Deterioration 7/542 (1.3%) 2/540 (0.4%) 0/93 (0%)
Hypothermia 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Mucosal Inflammation 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Multi-Organ Failure 0/542 (0%) 0/540 (0%) 1/93 (1.1%)
Non-Cardiac Chest Pain 1/542 (0.2%) 4/540 (0.7%) 1/93 (1.1%)
Oedema Peripheral 2/542 (0.4%) 0/540 (0%) 0/93 (0%)
Performance Status Decreased 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Systemic Inflammatory Response Syndrome 0/542 (0%) 0/540 (0%) 1/93 (1.1%)
Hepatobiliary disorders
Cholecystitis 2/542 (0.4%) 0/540 (0%) 0/93 (0%)
Cholelithiasis 0/542 (0%) 0/540 (0%) 1/93 (1.1%)
Jaundice 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Bile Duct Obstruction 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Infections and infestations
Bacteraemia 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Bronchitis 1/542 (0.2%) 2/540 (0.4%) 0/93 (0%)
Bronchopneumonia 0/542 (0%) 2/540 (0.4%) 0/93 (0%)
Cellulitis 2/542 (0.4%) 3/540 (0.6%) 2/93 (2.2%)
Cystitis 3/542 (0.6%) 0/540 (0%) 0/93 (0%)
Gastroenteritis 6/542 (1.1%) 1/540 (0.2%) 0/93 (0%)
Infection 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Influenza 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Osteomyelitis 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Pneumonia 10/542 (1.8%) 4/540 (0.7%) 1/93 (1.1%)
Pyelonephritis 3/542 (0.6%) 2/540 (0.4%) 1/93 (1.1%)
Sepsis 7/542 (1.3%) 2/540 (0.4%) 1/93 (1.1%)
Sinusitis 2/542 (0.4%) 1/540 (0.2%) 0/93 (0%)
Tracheobronchitis 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Urosepsis 3/542 (0.6%) 2/540 (0.4%) 1/93 (1.1%)
Anal Abscess 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Arthritis Bacterial 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Biliary Sepsis 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Bursitis Infective 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Campylobacter Gastroenteritis 1/542 (0.2%) 0/540 (0%) 1/93 (1.1%)
Enterococcal Infection 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Escherichia Urinary Tract Infection 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Febrile Infection 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Gallbladder Abscess 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Gastroenteritis Salmonella 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Gastroenteritis Viral 1/542 (0.2%) 1/540 (0.2%) 0/93 (0%)
Gastrointestinal Infection 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Gingival Infection 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Herpes Zoster 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Infected Skin Ulcer 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Infective Exacerbation of Chronic Obstructive Airways Disease 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Lower Respiratory Tract Infection 1/542 (0.2%) 1/540 (0.2%) 0/93 (0%)
Lung Infection 3/542 (0.6%) 0/540 (0%) 0/93 (0%)
Necrotising Fasciitis 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Parainfluenzae Virus Infection 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Pneumonia Influenzal 1/542 (0.2%) 1/540 (0.2%) 0/93 (0%)
Pneumonia Staphylococcal 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Postoperative Wound Infection 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Pseudomonal Bacteraemia 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Respiratory Tract Infection 3/542 (0.6%) 0/540 (0%) 0/93 (0%)
Skin Infection 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Staphylococcal Infection 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Urinary Tract Infection 14/542 (2.6%) 4/540 (0.7%) 5/93 (5.4%)
Urinary Tract Infection Bacterial 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Viral Infection 1/542 (0.2%) 1/540 (0.2%) 0/93 (0%)
Wound Infection 0/542 (0%) 0/540 (0%) 1/93 (1.1%)
Injury, poisoning and procedural complications
Fall 2/542 (0.4%) 2/540 (0.4%) 1/93 (1.1%)
Animal Scratch 0/542 (0%) 0/540 (0%) 1/93 (1.1%)
Ankle Fracture 1/542 (0.2%) 1/540 (0.2%) 0/93 (0%)
Bladder Perforation 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Cataract Operation Complication 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Cystitis Radiation 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Device Dislocation 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Femoral Neck Fracture 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Femur Fracture 2/542 (0.4%) 1/540 (0.2%) 0/93 (0%)
Gastroenteritis Radiation 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Gastrointestinal Anastomotic Leak 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Implantable Defibrillator Malfunction 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Multiple Fractures 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Multiple Injuries 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Narcotic Intoxication 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Procedural Pain 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Pubic Rami Fracture 1/542 (0.2%) 1/540 (0.2%) 0/93 (0%)
Scapula Fracture 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Skeletal Injury 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Skin Laceration 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Skull Fracture 1/542 (0.2%) 1/540 (0.2%) 0/93 (0%)
Soft Tissue Injury 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Spinal Compression Fracture 1/542 (0.2%) 1/540 (0.2%) 0/93 (0%)
Spinal Fracture 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Stress Fracture 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Subdural Haematoma 0/542 (0%) 2/540 (0.4%) 2/93 (2.2%)
Subdural Haemorrhage 0/542 (0%) 2/540 (0.4%) 0/93 (0%)
Tendon Rupture 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Thoracic Vertebral Fracture 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Tibia Fracture 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Wrist Fracture 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Investigations
Colonoscopy 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Alanine Aminotransferase Increased 5/542 (0.9%) 1/540 (0.2%) 0/93 (0%)
Aspartate Aminotransferase Increased 3/542 (0.6%) 1/540 (0.2%) 0/93 (0%)
Blood Creatinine Increased 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Blood Uric Acid Increased 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Electrocardiogram QT Prolonged 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Electrocardiogram St Segment Depression 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Lipase Increased 2/542 (0.4%) 0/540 (0%) 0/93 (0%)
Platelet Count Decreased 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Metabolism and nutrition disorders
Anorexia 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Dehydration 6/542 (1.1%) 1/540 (0.2%) 0/93 (0%)
Hyperuricaemia 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Hypoalbuminaemia 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Hypoglycaemia 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Hypokalaemia 2/542 (0.4%) 1/540 (0.2%) 0/93 (0%)
Hyponatraemia 2/542 (0.4%) 1/540 (0.2%) 1/93 (1.1%)
Failure to Thrive 2/542 (0.4%) 0/540 (0%) 0/93 (0%)
Fluid Retention 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia 2/542 (0.4%) 4/540 (0.7%) 0/93 (0%)
Arthritis 2/542 (0.4%) 0/540 (0%) 0/93 (0%)
Bursitis 0/542 (0%) 0/540 (0%) 1/93 (1.1%)
Osteitis 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Osteoarthritis 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Osteonecrosis 2/542 (0.4%) 1/540 (0.2%) 0/93 (0%)
Back Pain 6/542 (1.1%) 4/540 (0.7%) 1/93 (1.1%)
Bone Pain 4/542 (0.7%) 5/540 (0.9%) 1/93 (1.1%)
Flank Pain 2/542 (0.4%) 1/540 (0.2%) 0/93 (0%)
Groin Pain 2/542 (0.4%) 0/540 (0%) 0/93 (0%)
Jaw Cyst 0/542 (0%) 0/540 (0%) 1/93 (1.1%)
Joint Swelling 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Lumbar Spinal Stenosis 0/542 (0%) 0/540 (0%) 1/93 (1.1%)
Muscular Weakness 1/542 (0.2%) 0/540 (0%) 1/93 (1.1%)
Musculoskeletal Chest Pain 1/542 (0.2%) 1/540 (0.2%) 0/93 (0%)
Musculoskeletal Pain 1/542 (0.2%) 2/540 (0.4%) 0/93 (0%)
Pain in Extremity 1/542 (0.2%) 1/540 (0.2%) 2/93 (2.2%)
Pathological Fracture 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Rotator Cuff Syndrome 0/542 (0%) 0/540 (0%) 1/93 (1.1%)
Spinal Column Stenosis 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-Cell Type Acute Leukaemia 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Basal Cell Carcinoma 1/542 (0.2%) 0/540 (0%) 1/93 (1.1%)
Bladder Cancer 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Bladder Transitional Cell Carcinoma 0/542 (0%) 0/540 (0%) 1/93 (1.1%)
Cancer Pain 1/542 (0.2%) 1/540 (0.2%) 0/93 (0%)
Central Nervous System Lymphoma 1/542 (0.2%) 1/540 (0.2%) 0/93 (0%)
Chronic Lymphocytic Leukaemia 0/542 (0%) 0/540 (0%) 1/93 (1.1%)
Colon Adenoma 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Colon Cancer 0/542 (0%) 2/540 (0.4%) 0/93 (0%)
Colorectal Cancer 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Gastric Cancer 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Intestinal Adenocarcinoma 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Lung Adenocarcinoma 1/542 (0.2%) 1/540 (0.2%) 0/93 (0%)
Lung Neoplasm 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Lung Neoplasm Malignant 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Malignant Melanoma 1/542 (0.2%) 1/540 (0.2%) 0/93 (0%)
Malignant Neoplasm of Ampulla of Vater 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Metastases to Meninges 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Metastatic Pain 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Pancreatic Carcinoma 2/542 (0.4%) 0/540 (0%) 1/93 (1.1%)
Squamous Cell Carcinoma 1/542 (0.2%) 0/540 (0%) 1/93 (1.1%)
Urethral Cancer 0/542 (0%) 1/540 (0.2%) 1/93 (1.1%)
Nervous system disorders
Convulsion 0/542 (0%) 0/540 (0%) 1/93 (1.1%)
Dizziness 2/542 (0.4%) 1/540 (0.2%) 0/93 (0%)
Epilepsy 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Monoparesis 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Paraesthesia 2/542 (0.4%) 0/540 (0%) 0/93 (0%)
Paraparesis 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Paraplegia 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Presyncope 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Quadriparesis 0/542 (0%) 0/540 (0%) 1/93 (1.1%)
Sciatica 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Syncope 6/542 (1.1%) 1/540 (0.2%) 0/93 (0%)
VIth nerve paralysis 0/542 (0%) 0/540 (0%) 1/93 (1.1%)
Amyotrophic Lateral Sclerosis 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Carotid Artery Stenosis 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Cerebral Haemorrhage 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Cerebral Infarction 0/542 (0%) 2/540 (0.4%) 0/93 (0%)
Cerebral Ischaemia 3/542 (0.6%) 0/540 (0%) 0/93 (0%)
Cerebrovascular Accident 6/542 (1.1%) 2/540 (0.4%) 0/93 (0%)
Embolic Stroke 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Loss of Consciousness 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Memory Impairment 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Migraine with Aura 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Nerve Root Compression 2/542 (0.4%) 0/540 (0%) 1/93 (1.1%)
Neurological Symptom 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Spinal Cord Compression 7/542 (1.3%) 4/540 (0.7%) 0/93 (0%)
Syncope Vasovagal 2/542 (0.4%) 0/540 (0%) 0/93 (0%)
Transient Ischaemic Attack 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Psychiatric disorders
Agitation 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Delirium 0/542 (0%) 0/540 (0%) 1/93 (1.1%)
Completed Suicide 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Confusional State 1/542 (0.2%) 2/540 (0.4%) 0/93 (0%)
Renal and urinary disorders
Dysuria 1/542 (0.2%) 1/540 (0.2%) 0/93 (0%)
Haematuria 11/542 (2%) 5/540 (0.9%) 3/93 (3.2%)
Hydronephrosis 2/542 (0.4%) 4/540 (0.7%) 0/93 (0%)
Nephrolithiasis 3/542 (0.6%) 0/540 (0%) 0/93 (0%)
Pollakiuria 3/542 (0.6%) 2/540 (0.4%) 0/93 (0%)
Bladder Mass 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Bladder Obstruction 1/542 (0.2%) 1/540 (0.2%) 0/93 (0%)
Bladder Spasm 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Bladder Tamponade 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Calculus Bladder 0/542 (0%) 0/540 (0%) 2/93 (2.2%)
Calculus Ureteric 2/542 (0.4%) 0/540 (0%) 0/93 (0%)
Haemorrhage Urinary Tract 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Obstructive Uropathy 0/542 (0%) 2/540 (0.4%) 0/93 (0%)
Renal Colic 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Renal Failure 1/542 (0.2%) 3/540 (0.6%) 0/93 (0%)
Renal Failure Acute 3/542 (0.6%) 2/540 (0.4%) 1/93 (1.1%)
Renal Impairment 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Ureteric Obstruction 2/542 (0.4%) 2/540 (0.4%) 0/93 (0%)
Ureteric Stenosis 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Urethral Obstruction 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Urethral Stenosis 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Urinary Incontinence 1/542 (0.2%) 1/540 (0.2%) 0/93 (0%)
Urinary Retention 6/542 (1.1%) 3/540 (0.6%) 1/93 (1.1%)
Urinary Tract Obstruction 1/542 (0.2%) 1/540 (0.2%) 0/93 (0%)
Reproductive system and breast disorders
Prostatomegaly 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Erectile Dysfunction 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Prostatic Haemorrhage 0/542 (0%) 0/540 (0%) 1/93 (1.1%)
Scrotal Pain 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea 2/542 (0.4%) 5/540 (0.9%) 0/93 (0%)
Hypoxia 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Pneumothorax 3/542 (0.6%) 1/540 (0.2%) 0/93 (0%)
Acute Pulmonary Oedema 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Chronic Obstructive Pulmonary Disease 0/542 (0%) 2/540 (0.4%) 0/93 (0%)
Lung Disorder 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Pleural Effusion 1/542 (0.2%) 3/540 (0.6%) 0/93 (0%)
Pneumonia Aspiration 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Pulmonary Embolism 10/542 (1.8%) 12/540 (2.2%) 1/93 (1.1%)
Respiratory Failure 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Tonsillar Cyst 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Skin and subcutaneous tissue disorders
Lentigo 0/542 (0%) 0/540 (0%) 1/93 (1.1%)
Actinic Keratosis 0/542 (0%) 0/540 (0%) 1/93 (1.1%)
Skin Lesion 0/542 (0%) 0/540 (0%) 1/93 (1.1%)
Surgical and medical procedures
Chemotherapy 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Pancreatectomy 2/542 (0.4%) 0/540 (0%) 0/93 (0%)
Aortic Valve Replacement 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Knee Arthroplasty 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Transurethral Prostatectomy 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Vascular disorders
Hypertension 1/542 (0.2%) 3/540 (0.6%) 0/93 (0%)
Hypotension 1/542 (0.2%) 1/540 (0.2%) 0/93 (0%)
Thrombophlebitis 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Thrombosis 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Arterial Thrombosis 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Deep Vein Thrombosis 4/542 (0.7%) 2/540 (0.4%) 0/93 (0%)
Embolism Venous 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Hypertensive Crisis 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Orthostatic Hypotension 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Peripheral Embolism 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Peripheral Vascular Disorder 1/542 (0.2%) 0/540 (0%) 0/93 (0%)
Venous Thrombosis 0/542 (0%) 1/540 (0.2%) 0/93 (0%)
Other (Not Including Serious) Adverse Events
Abiraterone Acetate + Prednisone (AAP) Placebo Placebo to AA
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 530/542 (97.8%) 505/540 (93.5%) 86/93 (92.5%)
Blood and lymphatic system disorders
Anaemia 59/542 (10.9%) 53/540 (9.8%) 12/93 (12.9%)
Gastrointestinal disorders
Constipation 144/542 (26.6%) 112/540 (20.7%) 15/93 (16.1%)
Diarrhoea 135/542 (24.9%) 98/540 (18.1%) 13/93 (14%)
Dyspepsia 62/542 (11.4%) 28/540 (5.2%) 1/93 (1.1%)
Nausea 144/542 (26.6%) 127/540 (23.5%) 15/93 (16.1%)
Vomiting 86/542 (15.9%) 61/540 (11.3%) 12/93 (12.9%)
Abdominal Pain 49/542 (9%) 44/540 (8.1%) 5/93 (5.4%)
General disorders
Asthenia 46/542 (8.5%) 46/540 (8.5%) 1/93 (1.1%)
Fatigue 243/542 (44.8%) 200/540 (37%) 27/93 (29%)
Pyrexia 54/542 (10%) 33/540 (6.1%) 5/93 (5.4%)
Oedema Peripheral 148/542 (27.3%) 119/540 (22%) 22/93 (23.7%)
Infections and infestations
Bronchitis 34/542 (6.3%) 14/540 (2.6%) 0/93 (0%)
Nasopharyngitis 65/542 (12%) 46/540 (8.5%) 5/93 (5.4%)
Sinusitis 29/542 (5.4%) 5/540 (0.9%) 3/93 (3.2%)
Lower Respiratory Tract Infection 12/542 (2.2%) 13/540 (2.4%) 5/93 (5.4%)
Upper Respiratory Tract Infection 74/542 (13.7%) 43/540 (8%) 4/93 (4.3%)
Urinary Tract Infection 49/542 (9%) 40/540 (7.4%) 11/93 (11.8%)
Injury, poisoning and procedural complications
Contusion 81/542 (14.9%) 49/540 (9.1%) 6/93 (6.5%)
Fall 47/542 (8.7%) 20/540 (3.7%) 12/93 (12.9%)
Skin Laceration 13/542 (2.4%) 15/540 (2.8%) 6/93 (6.5%)
Investigations
Alanine Aminotransferase Increased 70/542 (12.9%) 26/540 (4.8%) 3/93 (3.2%)
Aspartate Aminotransferase Increased 63/542 (11.6%) 25/540 (4.6%) 4/93 (4.3%)
Weight Decreased 42/542 (7.7%) 27/540 (5%) 6/93 (6.5%)
Weight Increased 29/542 (5.4%) 40/540 (7.4%) 2/93 (2.2%)
Metabolism and nutrition disorders
Anorexia 56/542 (10.3%) 40/540 (7.4%) 10/93 (10.8%)
Hyperglycaemia 52/542 (9.6%) 41/540 (7.6%) 6/93 (6.5%)
Hypokalaemia 99/542 (18.3%) 68/540 (12.6%) 9/93 (9.7%)
Hyponatraemia 14/542 (2.6%) 15/540 (2.8%) 5/93 (5.4%)
Decreased Appetite 28/542 (5.2%) 30/540 (5.6%) 0/93 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia 172/542 (31.7%) 131/540 (24.3%) 19/93 (20.4%)
Myalgia 40/542 (7.4%) 32/540 (5.9%) 3/93 (3.2%)
Back Pain 199/542 (36.7%) 180/540 (33.3%) 26/93 (28%)
Bone Pain 144/542 (26.6%) 112/540 (20.7%) 14/93 (15.1%)
Groin Pain 41/542 (7.6%) 22/540 (4.1%) 0/93 (0%)
Muscle Spasms 78/542 (14.4%) 111/540 (20.6%) 2/93 (2.2%)
Muscular Weakness 35/542 (6.5%) 42/540 (7.8%) 5/93 (5.4%)
Musculoskeletal Pain 97/542 (17.9%) 77/540 (14.3%) 12/93 (12.9%)
Neck Pain 30/542 (5.5%) 17/540 (3.1%) 2/93 (2.2%)
Pain in Extremity 107/542 (19.7%) 89/540 (16.5%) 16/93 (17.2%)
Nervous system disorders
Dizziness 81/542 (14.9%) 73/540 (13.5%) 7/93 (7.5%)
Headache 86/542 (15.9%) 66/540 (12.2%) 9/93 (9.7%)
Neuropathy Peripheral 12/542 (2.2%) 6/540 (1.1%) 7/93 (7.5%)
Psychiatric disorders
Anxiety 30/542 (5.5%) 23/540 (4.3%) 4/93 (4.3%)
Depression 32/542 (5.9%) 19/540 (3.5%) 3/93 (3.2%)
Insomnia 82/542 (15.1%) 62/540 (11.5%) 5/93 (5.4%)
Renal and urinary disorders
Haematuria 56/542 (10.3%) 32/540 (5.9%) 4/93 (4.3%)
Nocturia 38/542 (7%) 29/540 (5.4%) 0/93 (0%)
Pollakiuria 56/542 (10.3%) 55/540 (10.2%) 2/93 (2.2%)
Urinary Incontinence 37/542 (6.8%) 25/540 (4.6%) 0/93 (0%)
Respiratory, thoracic and mediastinal disorders
Cough 106/542 (19.6%) 74/540 (13.7%) 11/93 (11.8%)
Dyspnoea 71/542 (13.1%) 52/540 (9.6%) 7/93 (7.5%)
Skin and subcutaneous tissue disorders
Rash 49/542 (9%) 21/540 (3.9%) 1/93 (1.1%)
Vascular disorders
Hypertension 129/542 (23.8%) 73/540 (13.5%) 6/93 (6.5%)
Hot Flush 124/542 (22.9%) 100/540 (18.5%) 6/93 (6.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

A copy of the manuscript must be provided to the Sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.

Results Point of Contact

Name/Title SENIOR DIRECTOR CLINICAL RESEARCH
Organization Janssen R&D US
Phone
Email ClinicalTrialDisclosure@its.jnj.com
Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00887198
Other Study ID Numbers:
  • CR016927
  • COU-AA-302
  • 2008-008004-41
First Posted:
Apr 23, 2009
Last Update Posted:
Jun 25, 2018
Last Verified:
May 1, 2018