An Efficacy and Safety Study of Abiraterone Acetate and Prednisone in Participants With Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy

• Sponsor: Cougar Biotechnology, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00485303
• Collaborator: (none)
• Enrollment: 58
• Locations: 14
• Arm: 1
• Duration (Months): 52
• Patients Per Site: 4.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of abiraterone acetate in participants with advanced prostate cancer (a disease in which cells in the prostate gland become abnormal and start to grow uncontrollably, forming tumors).

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms; Prostate Cancer	Drug: Abiraterone acetate; Drug: Prednisone	Phase 2

Detailed Description

This is an open-label (all people know the identity of the intervention), single-arm, multicenter (when more than one hospital or medical school team work on a medical research study) study to evaluate the anti-tumor activities and safety of abiraterone acetate in participants with prostate cancer who have failed androgen deprivation and docetaxel-based chemotherapy. Abiraterone acetate oral tablet will be administered as a total dose of 1000 milligram (mg) orally (by mouth) once daily after an overnight fast and prednisone/prednisolone will be administered as 5 mg oral tablet twice daily. Participants will be enrolled and treated up to 12 cycles (or longer, if they have not progressed and continue to benefit from treatment). The study will consist of 3 parts: Screening (14 days), Open-label Treatment; and follow-up (up to 60 months). Participants will be evaluated primarily for prostate specific antigen response according to Prostate Specific Antigen Working Group (PSAWG) criteria. Participants' safety will be monitored throughout the study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 58 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Open Label Study of CB7630 (Abiraterone Acetate) and Prednisone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy
• Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Abiraterone Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) will be administered once daily along with 5 mg oral prednisolone tablet administered twice daily for 28-days dosing cycle and will be continued until disease progression or unacceptable toxicity.	Drug: Abiraterone acetate; Abiraterone acetate oral tablets 250 milligram (mg) each will be administered at a total dose of 1000 mg until documented disease progression or unacceptable toxicity.; Drug: Prednisone; Prednisone/Prednisolone 5 mg tablet will be taken orally twice daily.; Other Names: CB7630

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Prostate Specific Antigen (PSA) Response [Day 1 of each cycle (of 28 days each) up to Cycle 12]

   The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline during the study, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA response.

Secondary Outcome Measures

1. Prostate-Specific Antigen Based Progression-free Survival (PSA-PFS) [Baseline and Day 1 of each cycle until first documented disease progression or up to 60 months]

   The PSA-PFS is defined as time to first PSA failure (that is, two consecutive increases in PSA of 50 percent and greater than or equal to 5 nanogram per milliliter, as per Prostate-Specific Antigen Working Group [PSAWG] criterion) or death or the start of secondary anti-tumor therapy, whichever occurs first. If a PSA progression or death does not occur, subject will be censored at the last PSA evaluation.

2. Radiographic Progression Free Survival (PFS) [Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months]

   The RAD-PFS is defined as the time from randomization to the earliest objective evidence of radiographic progression or death due to any cause. Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0, as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.

3. Overall Survival (OS) [Every 3 months until death or up to 60 months]

   Overall survival is defined as the interval from the date of the first dose of abiraterone acetate to the date of death.

4. Percentage of Participants With Objective Radiographic Response [Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months]

   Percentage of participants with radiographic objective response is defined as the percentage of participants with complete response (CR) or partial response (PR) as best overall response based on reconciled radiographic disease assessment according to RECIST Version 1.0. The CR is disappearance of all lesions. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.

5. Time to PSA Progression [Day 8 of Cycle 1, thereafter Day 1 of each cycle up to end of study (60 months)]

   The time interval from first dose of abiraterone acetate to the date of PSA progression as defined by the Prostate-Specific Antigen Working Group (PSAWG) criteria. If a PSA progression does not occur, subject will be censored at the last PSA evaluation.

6. Time to Radiographic Progression [Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months]

   Time to radiographic progression is defined as the time from first dose until the first radiographic progression date that was confirmed.

7. Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score [Baseline and Day 1 of each cycle until first documented disease progression or up to 60 months]

   ECOG performance status score ranges from 0 to 5 where 0=fully active, perform all pre-disease activities without restriction. 1=restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature, 2=ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (>) 50 percent of waking hours, 3=capable of limited self-care, confined to bed or chair >50 percent of waking hours, 4=completely disabled, not capable of any self-care, totally confined to bed or chair and 5=dead.

8. Percentage of Participants With Clinical Benefit [Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months]

   Clinical benefit was defined as an observation of at least 1 of the following: PSA response by PSAWG criteria; radiographic response by RECIST criteria; stable disease by RECIST criteria lasting 6 months; or improvement by at least 1 unit in ECOG performance status.

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 (malignant epithelial tumor with a glandular organization)of the prostate (a gland in the male reproductive system found below the bladder and in front of the rectum), but not with neuroendocrine (specialized neurons that produce hormones, such as neuropeptides or biogenic amines) differentiation or of small cell histology

• Prior chemotherapy (treatment of disease, usually cancer, by chemical agents) for prostate cancer with regimen(s) containing docetaxel

• Documented prostate specific antigen (PSA) progression according to Prostate Specific Antigen Working Group (PSAWG) eligibility criteria with a PSA more than (>) 5 nanogram per milliliter (ng/mL) or objective progression by Response Evaluation Criteria in Solid Tumors (RESIST) criteria

• Ongoing androgen deprivation with serum testosterone less than (<) 50 nanogram per deciliter (ng/dL)

• Eastern Cooperative Oncology Group (ECOG) Performance Status of less than equal to (<=) 2 (Karnofsky Performance Status >= 50 percent)

Exclusion Criteria:

• Active or uncontrolled autoimmune disease (disorder in which a person's immune system attacks parts of his or her own body) that may require corticosteroid therapy

• Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection

• Uncontrolled hypertension (high blood pressure)

• Hemoglobin <=9.0 gram per deciliter (g/dL) without growth factor or transfusion support

• Abnormal liver (large organ that helps in many body functions, including digestion, metabolism, and storage of substances) function

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA	Los Angeles	California	United States	90024
2		Los Angeles	California	United States
3	UCSF Comprehensive Cancer Center	San Francisco	California	United States	94115
4		San Francisco	California	United States
5	John Hopkins	Baltimore	Maryland	United States	21205
6		Baltimore	Maryland	United States
7	Masachussetts General Hospital Cancer Center	Boston	Massachusetts	United States	02114
8	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115
9	Beth Israel Hospital	Boston	Massachusetts	United States	02215
10		Boston	Massachusetts	United States
11	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
12		New York	New York	United States
13	Royal Marsden Hospital	Sutton		United Kingdom
14		Sutton		United Kingdom

Sponsors and Collaborators

• Cougar Biotechnology, Inc.

Investigators

• Study Director: Cougar Biotechnology, Inc. Clinical Trial, Cougar Biotechnology, Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• NATIONAL CANCER INSTITUTE
• PROSTATE CANCER

Publications

None provided.

• Responsible Party: Cougar Biotechnology, Inc.
• ClinicalTrials.gov Identifier: NCT00485303
• Other Study ID Numbers: CR016921; COU-AA-004; 2007-002725-74
• First Posted: Jun 12, 2007
• Last Update Posted: Jul 2, 2013
• Last Verified: Jun 1, 2013

• Keywords provided by Cougar Biotechnology, Inc.: Prostatic Neoplasms; Prostate cancer; Abiraterone acetate; CB7630; Prednisone
• Additional relevant MeSH terms: Prostatic Neoplasms; Prednisone; Abiraterone Acetate

Study Results

Participant Flow

Arm/Group Title	Abiraterone
Arm/Group Description	Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
Period Title: Overall Study
STARTED	58
COMPLETED	2
NOT COMPLETED	56

Baseline Characteristics

Arm/Group Title	Abiraterone
Arm/Group Description	Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
Overall Participants	58
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	68.6 (9.78)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	58 100%
Region of Enrollment (Number) [Number]
United Kingdom	4 6.9%
United States	54 93.1%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Prostate Specific Antigen (PSA) Response
Description	The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline during the study, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA response.
Time Frame	Day 1 of each cycle (of 28 days each) up to Cycle 12

Outcome Measure Data

Analysis Population Description

Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.

Arm/Group Title	Abiraterone
Arm/Group Description	Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
Measure Participants	58
Number (95% Confidence Interval) [percentage of participants]	37.9 65.3%

2. Secondary Outcome

Title	Prostate-Specific Antigen Based Progression-free Survival (PSA-PFS)
Description	The PSA-PFS is defined as time to first PSA failure (that is, two consecutive increases in PSA of 50 percent and greater than or equal to 5 nanogram per milliliter, as per Prostate-Specific Antigen Working Group [PSAWG] criterion) or death or the start of secondary anti-tumor therapy, whichever occurs first. If a PSA progression or death does not occur, subject will be censored at the last PSA evaluation.
Time Frame	Baseline and Day 1 of each cycle until first documented disease progression or up to 60 months

Outcome Measure Data

Analysis Population Description

Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.

Arm/Group Title	Abiraterone
Arm/Group Description	Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
Measure Participants	58
Median (95% Confidence Interval) [days]	141

3. Secondary Outcome

Title	Radiographic Progression Free Survival (PFS)
Description	The RAD-PFS is defined as the time from randomization to the earliest objective evidence of radiographic progression or death due to any cause. Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0, as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
Time Frame	Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Abiraterone
Arm/Group Description	Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
Measure Participants	58
Median (95% Confidence Interval) [days]	126

4. Secondary Outcome

Title	Overall Survival (OS)
Description	Overall survival is defined as the interval from the date of the first dose of abiraterone acetate to the date of death.
Time Frame	Every 3 months until death or up to 60 months

Outcome Measure Data

Analysis Population Description

Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.

Arm/Group Title	Abiraterone
Arm/Group Description	Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
Measure Participants	58
Median (95% Confidence Interval) [days]	492

5. Secondary Outcome

Title	Percentage of Participants With Objective Radiographic Response
Description	Percentage of participants with radiographic objective response is defined as the percentage of participants with complete response (CR) or partial response (PR) as best overall response based on reconciled radiographic disease assessment according to RECIST Version 1.0. The CR is disappearance of all lesions. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.
Time Frame	Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months

Outcome Measure Data

Analysis Population Description

Per protocol population defined as participants who had received at least 1 dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment. "N" (number of participants analyzed) =participants who were evaluable for this measure.

Arm/Group Title	Abiraterone
Arm/Group Description	Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
Measure Participants	48
Complete response (CR)	0 0%
Partial Response (PR)	6.3 10.9%

6. Secondary Outcome

Title	Time to PSA Progression
Description	The time interval from first dose of abiraterone acetate to the date of PSA progression as defined by the Prostate-Specific Antigen Working Group (PSAWG) criteria. If a PSA progression does not occur, subject will be censored at the last PSA evaluation.
Time Frame	Day 8 of Cycle 1, thereafter Day 1 of each cycle up to end of study (60 months)

Outcome Measure Data

Analysis Population Description

Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.

Arm/Group Title	Abiraterone
Arm/Group Description	Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
Measure Participants	58
Median (95% Confidence Interval) [days]	169

7. Secondary Outcome

Title	Time to Radiographic Progression
Description	Time to radiographic progression is defined as the time from first dose until the first radiographic progression date that was confirmed.
Time Frame	Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months

Outcome Measure Data

Analysis Population Description

Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.

Arm/Group Title	Abiraterone
Arm/Group Description	Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
Measure Participants	58
Median (95% Confidence Interval) [days]	88

8. Secondary Outcome

Title	Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Description	ECOG performance status score ranges from 0 to 5 where 0=fully active, perform all pre-disease activities without restriction. 1=restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature, 2=ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (>) 50 percent of waking hours, 3=capable of limited self-care, confined to bed or chair >50 percent of waking hours, 4=completely disabled, not capable of any self-care, totally confined to bed or chair and 5=dead.
Time Frame	Baseline and Day 1 of each cycle until first documented disease progression or up to 60 months

Outcome Measure Data

Analysis Population Description

Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment. 'N' (number of participants analyzed) = participants who were evaluable for this measure.

Arm/Group Title	Abiraterone
Arm/Group Description	Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
Measure Participants	57
Baseline:0; Best Post-dose:0	22 37.9%
Baseline:0; Best Post-dose:1	2 3.4%
Baseline:0; Best Post-dose:2	0 0%
Baseline:0; Best Post-dose:3	0 0%
Baseline:0; Best Post-dose:4	0 0%
Baseline:1; Best Post-dose:0	14 24.1%
Baseline:1; Best Post-dose:1	15 25.9%
Baseline:1; Best Post-dose:2	2 3.4%
Baseline:1; Best Post-dose:3	0 0%
Baseline:1; Best Post-dose:4	0 0%
Baseline:2; Best Post-dose:0	1 1.7%
Baseline:2; Best Post-dose:1	1 1.7%
Baseline:2; Best Post-dose:2	0 0%
Baseline:2; Best Post-dose:3	0 0%
Baseline:2; Best Post-dose:4	0 0%
Baseline:0; Worst Post-dose:0	6 10.3%
Baseline:0; Worst Post-dose:1	17 29.3%
Baseline:0; Worst Post-dose:2	1 1.7%
Baseline:0; Worst Post-dose:3	0 0%
Baseline:0; Worst Post-dose:4	0 0%
Baseline:1; Worst Post-dose:0	0 0%
Baseline:1; Worst Post-dose:1	24 41.4%
Baseline:1; Worst Post-dose:2	6 10.3%
Baseline:1; Worst Post-dose:3	1 1.7%
Baseline:1; Worst Post-dose:4	0 0%
Baseline:2; Worst Post-dose:0	0 0%
Baseline:2; Worst Post-dose:1	0 0%
Baseline:2; Worst Post-dose:2	2 3.4%
Baseline:2; Worst Post-dose:3	0 0%
Baseline:2; Worst Post-dose:4	0 0%

9. Secondary Outcome

Title	Percentage of Participants With Clinical Benefit
Description	Clinical benefit was defined as an observation of at least 1 of the following: PSA response by PSAWG criteria; radiographic response by RECIST criteria; stable disease by RECIST criteria lasting 6 months; or improvement by at least 1 unit in ECOG performance status.
Time Frame	Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months

Outcome Measure Data

Analysis Population Description

Per protocol population defined as participants who had received at least one dose of abiraterone acetate and must had PSA evaluation/tumor assessment at Baseline and at least 1 post-baseline, and had received a minimum of 3 cycles of study treatment.

Arm/Group Title	Abiraterone
Arm/Group Description	Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
Measure Participants	58
Disease Stabilization	12 20.7%
Change in participant ECOG score	16 27.6%

Adverse Events

Time Frame	Day 8 of Cycle 1 up to End of Study
Arm/Group Title	Abiraterone
Arm/Group Description	Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
All Cause Mortality
	Abiraterone
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Abiraterone
	Affected / at Risk (%)	# Events
Total	23/58 (39.7%)
Blood and lymphatic system disorders
Anaemia	1/58 (1.7%)
Cardiac disorders
Angina pectoris	1/58 (1.7%)
Atrial fibrillation	2/58 (3.4%)
Supraventricular tachycardia	1/58 (1.7%)
Ventricular tachycardia	1/58 (1.7%)
Gastrointestinal disorders
Constipation	1/58 (1.7%)
Vomiting	1/58 (1.7%)
General disorders
Disease progression	1/58 (1.7%)
Fatigue	2/58 (3.4%)
Pyrexia	4/58 (6.9%)
Infections and infestations
Cellulitis	1/58 (1.7%)
Pneumonia	2/58 (3.4%)
Injury, poisoning and procedural complications
Sternal fracture	1/58 (1.7%)
Investigations
Alanine aminotransferase increased	1/58 (1.7%)
Aspartate aminotransferase increased	1/58 (1.7%)
Blood amylase increased	1/58 (1.7%)
Blood creatinine increased	1/58 (1.7%)
Blood potassium increased	1/58 (1.7%)
Haemoglobin decreased	2/58 (3.4%)
White blood cell count decreased	1/58 (1.7%)
Metabolism and nutrition disorders
Dehydration	1/58 (1.7%)
Hyperglycaemia	1/58 (1.7%)
Musculoskeletal and connective tissue disorders
Back pain	4/58 (6.9%)
Muscular weakness	2/58 (3.4%)
Musculoskeletal pain	1/58 (1.7%)
Myalgia	1/58 (1.7%)
Myositis	1/58 (1.7%)
Pain in extremity	2/58 (3.4%)
Nervous system disorders
Dizziness	2/58 (3.4%)
Spinal cord compression	2/58 (3.4%)
Syncope	2/58 (3.4%)
Renal and urinary disorders
Haematuria	2/58 (3.4%)
Haemorrhage urinary tract	1/58 (1.7%)
Renal failure	2/58 (3.4%)
Reproductive system and breast disorders
Pelvic pain	1/58 (1.7%)
Scrotal swelling	1/58 (1.7%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/58 (1.7%)
Hypoxia	1/58 (1.7%)
Lung infiltration	1/58 (1.7%)
Pneumonitis	1/58 (1.7%)
Skin and subcutaneous tissue disorders
Exfoliative rash	1/58 (1.7%)
Skin disorder	1/58 (1.7%)
Vascular disorders
Aortic stenosis	1/58 (1.7%)
Hypotension	1/58 (1.7%)
Other (Not Including Serious) Adverse Events
	Abiraterone
	Affected / at Risk (%)	# Events
Total	57/58 (98.3%)
Blood and lymphatic system disorders
Anaemia	15/58 (25.9%)
Lymphopenia	6/58 (10.3%)
Gastrointestinal disorders
Abdominal pain	4/58 (6.9%)
Constipation	15/58 (25.9%)
Diarrhoea	10/58 (17.2%)
Nausea	11/58 (19%)
Vomiting	9/58 (15.5%)
General disorders
Fatigue	23/58 (39.7%)
Oedema peripheral	18/58 (31%)
Pain	4/58 (6.9%)
Pyrexia	9/58 (15.5%)
Infections and infestations
Upper respiratory tract infection	4/58 (6.9%)
Urinary tract infection	6/58 (10.3%)
Investigations
Alanine aminotransferase increased	6/58 (10.3%)
Aspartate aminotransferase increased	15/58 (25.9%)
Blood albumin decreased	12/58 (20.7%)
Blood alkaline phosphatase increased	4/58 (6.9%)
Weight decreased	10/58 (17.2%)
Metabolism and nutrition disorders
Anorexia	8/58 (13.8%)
Hyperglycaemia	12/58 (20.7%)
Hyperkalaemia	7/58 (12.1%)
Hypoglycaemia	5/58 (8.6%)
Hypokalaemia	4/58 (6.9%)
Musculoskeletal and connective tissue disorders
Arthralgia	13/58 (22.4%)
Back pain	15/58 (25.9%)
Bone pain	7/58 (12.1%)
Flank pain	3/58 (5.2%)
Groin pain	5/58 (8.6%)
Muscle spasms	6/58 (10.3%)
Muscular weakness	6/58 (10.3%)
Musculoskeletal pain	9/58 (15.5%)
Pain in extremity	9/58 (15.5%)
Nervous system disorders
Headache	3/58 (5.2%)
Hypoaesthesia	4/58 (6.9%)
Peripheral sensory neuropathy	9/58 (15.5%)
Psychiatric disorders
Anxiety	4/58 (6.9%)
Depressed mood	3/58 (5.2%)
Insomnia	4/58 (6.9%)
Renal and urinary disorders
Dysuria	4/58 (6.9%)
Haemorrhage urinary tract	5/58 (8.6%)
Micturition urgency	3/58 (5.2%)
Nocturia	4/58 (6.9%)
Pollakiuria	4/58 (6.9%)
Urinary incontinence	3/58 (5.2%)
Respiratory, thoracic and mediastinal disorders
Cough	5/58 (8.6%)
Dyspnoea	10/58 (17.2%)
Productive cough	3/58 (5.2%)
Skin and subcutaneous tissue disorders
Ecchymosis	4/58 (6.9%)
Vascular disorders
Hot flush	6/58 (10.3%)
Hypertension	3/58 (5.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.