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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00485303
Recruitment Status : Completed
First Posted : June 12, 2007
Results First Posted : June 17, 2013
Last Update Posted : July 2, 2013
Sponsor:
Information provided by (Responsible Party):
Cougar Biotechnology, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Prostatic Neoplasms
Prostate Cancer
Interventions Drug: Abiraterone acetate
Drug: Prednisone
Enrollment 58
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Abiraterone
Hide 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
Reason Not Completed
Adverse Event             5
Progressive Disease             44
Other             3
Initiation of new anti-cancer treatment             2
Treatment ongoing at cutoff date             2
Arm/Group Title Abiraterone
Hide 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 Number of Baseline Participants 58
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 58 participants
68.6  (9.78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants
Female
0
   0.0%
Male
58
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 58 participants
United Kingdom 4
United States 54
1.Primary Outcome
Title Percentage of Participants With Prostate Specific Antigen (PSA) Response
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 58
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
37.9
(25.5 to 51.6)
2.Secondary Outcome
Title Prostate-Specific Antigen Based Progression-free Survival (PSA-PFS)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 58
Median (95% Confidence Interval)
Unit of Measure: days
141
(110 to 200)
3.Secondary Outcome
Title Radiographic Progression Free Survival (PFS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Abiraterone
Hide 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 Number of Participants Analyzed 58
Median (95% Confidence Interval)
Unit of Measure: days
126
(82 to 333)
4.Secondary Outcome
Title Overall Survival (OS)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 58
Median (95% Confidence Interval)
Unit of Measure: days
492
(373 to 647)
5.Secondary Outcome
Title Percentage of Participants With Objective Radiographic Response
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: percentage of participants
Complete response (CR) 0
Partial Response (PR) 6.3
6.Secondary Outcome
Title Time to PSA Progression
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 58
Median (95% Confidence Interval)
Unit of Measure: days
169
(99 to 225)
7.Secondary Outcome
Title Time to Radiographic Progression
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 58
Median (95% Confidence Interval)
Unit of Measure: days
88
(82 to 333)
8.Secondary Outcome
Title Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: participants
Baseline:0; Best Post-dose:0 22
Baseline:0; Best Post-dose:1 2
Baseline:0; Best Post-dose:2 0
Baseline:0; Best Post-dose:3 0
Baseline:0; Best Post-dose:4 0
Baseline:1; Best Post-dose:0 14
Baseline:1; Best Post-dose:1 15
Baseline:1; Best Post-dose:2 2
Baseline:1; Best Post-dose:3 0
Baseline:1; Best Post-dose:4 0
Baseline:2; Best Post-dose:0 1
Baseline:2; Best Post-dose:1 1
Baseline:2; Best Post-dose:2 0
Baseline:2; Best Post-dose:3 0
Baseline:2; Best Post-dose:4 0
Baseline:0; Worst Post-dose:0 6
Baseline:0; Worst Post-dose:1 17
Baseline:0; Worst Post-dose:2 1
Baseline:0; Worst Post-dose:3 0
Baseline:0; Worst Post-dose:4 0
Baseline:1; Worst Post-dose:0 0
Baseline:1; Worst Post-dose:1 24
Baseline:1; Worst Post-dose:2 6
Baseline:1; Worst Post-dose:3 1
Baseline:1; Worst Post-dose:4 0
Baseline:2; Worst Post-dose:0 0
Baseline:2; Worst Post-dose:1 0
Baseline:2; Worst Post-dose:2 2
Baseline:2; Worst Post-dose:3 0
Baseline:2; Worst Post-dose:4 0
9.Secondary Outcome
Title Percentage of Participants With Clinical Benefit
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 58
Measure Type: Number
Unit of Measure: percentage of participants
Disease Stabilization 12
Change in participant ECOG score 16
Time Frame Day 8 of Cycle 1 up to End of Study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Abiraterone
Hide 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 (%)
Total   --/-- 
Hide Serious Adverse Events
Abiraterone
Affected / at Risk (%)
Total   23/58 (39.66%) 
Blood and lymphatic system disorders   
Anaemia * 1  1/58 (1.72%) 
Cardiac disorders   
Angina pectoris * 1  1/58 (1.72%) 
Atrial fibrillation * 1  2/58 (3.45%) 
Supraventricular tachycardia * 1  1/58 (1.72%) 
Ventricular tachycardia * 1  1/58 (1.72%) 
Gastrointestinal disorders   
Constipation * 1  1/58 (1.72%) 
Vomiting * 1  1/58 (1.72%) 
General disorders   
Disease progression * 1  1/58 (1.72%) 
Fatigue * 1  2/58 (3.45%) 
Pyrexia * 1  4/58 (6.90%) 
Infections and infestations   
Cellulitis * 1  1/58 (1.72%) 
Pneumonia * 1  2/58 (3.45%) 
Injury, poisoning and procedural complications   
Sternal fracture * 1  1/58 (1.72%) 
Investigations   
Alanine aminotransferase increased * 1  1/58 (1.72%) 
Aspartate aminotransferase increased * 1  1/58 (1.72%) 
Blood amylase increased * 1  1/58 (1.72%) 
Blood creatinine increased * 1  1/58 (1.72%) 
Blood potassium increased * 1  1/58 (1.72%) 
Haemoglobin decreased * 1  2/58 (3.45%) 
White blood cell count decreased * 1  1/58 (1.72%) 
Metabolism and nutrition disorders   
Dehydration * 1  1/58 (1.72%) 
Hyperglycaemia * 1  1/58 (1.72%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  4/58 (6.90%) 
Muscular weakness * 1  2/58 (3.45%) 
Musculoskeletal pain * 1  1/58 (1.72%) 
Myalgia * 1  1/58 (1.72%) 
Myositis * 1  1/58 (1.72%) 
Pain in extremity * 1  2/58 (3.45%) 
Nervous system disorders   
Dizziness * 1  2/58 (3.45%) 
Spinal cord compression * 1  2/58 (3.45%) 
Syncope * 1  2/58 (3.45%) 
Renal and urinary disorders   
Haematuria * 1  2/58 (3.45%) 
Haemorrhage urinary tract * 1  1/58 (1.72%) 
Renal failure * 1  2/58 (3.45%) 
Reproductive system and breast disorders   
Pelvic pain * 1  1/58 (1.72%) 
Scrotal swelling * 1  1/58 (1.72%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea * 1  1/58 (1.72%) 
Hypoxia * 1  1/58 (1.72%) 
Lung infiltration * 1  1/58 (1.72%) 
Pneumonitis * 1  1/58 (1.72%) 
Skin and subcutaneous tissue disorders   
Exfoliative rash * 1  1/58 (1.72%) 
Skin disorder * 1  1/58 (1.72%) 
Vascular disorders   
Aortic stenosis * 1  1/58 (1.72%) 
Hypotension * 1  1/58 (1.72%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 11.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Abiraterone
Affected / at Risk (%)
Total   57/58 (98.28%) 
Blood and lymphatic system disorders   
Anaemia * 1  15/58 (25.86%) 
Lymphopenia * 1  6/58 (10.34%) 
Gastrointestinal disorders   
Abdominal pain * 1  4/58 (6.90%) 
Constipation * 1  15/58 (25.86%) 
Diarrhoea * 1  10/58 (17.24%) 
Nausea * 1  11/58 (18.97%) 
Vomiting * 1  9/58 (15.52%) 
General disorders   
Fatigue * 1  23/58 (39.66%) 
Oedema peripheral * 1  18/58 (31.03%) 
Pain * 1  4/58 (6.90%) 
Pyrexia * 1  9/58 (15.52%) 
Infections and infestations   
Upper respiratory tract infection * 1  4/58 (6.90%) 
Urinary tract infection * 1  6/58 (10.34%) 
Investigations   
Alanine aminotransferase increased * 1  6/58 (10.34%) 
Aspartate aminotransferase increased * 1  15/58 (25.86%) 
Blood albumin decreased * 1  12/58 (20.69%) 
Blood alkaline phosphatase increased * 1  4/58 (6.90%) 
Weight decreased * 1  10/58 (17.24%) 
Metabolism and nutrition disorders   
Anorexia * 1  8/58 (13.79%) 
Hyperglycaemia * 1  12/58 (20.69%) 
Hyperkalaemia * 1  7/58 (12.07%) 
Hypoglycaemia * 1  5/58 (8.62%) 
Hypokalaemia * 1  4/58 (6.90%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  13/58 (22.41%) 
Back pain * 1  15/58 (25.86%) 
Bone pain * 1  7/58 (12.07%) 
Flank pain * 1  3/58 (5.17%) 
Groin pain * 1  5/58 (8.62%) 
Muscle spasms * 1  6/58 (10.34%) 
Muscular weakness * 1  6/58 (10.34%) 
Musculoskeletal pain * 1  9/58 (15.52%) 
Pain in extremity * 1  9/58 (15.52%) 
Nervous system disorders   
Headache * 1  3/58 (5.17%) 
Hypoaesthesia * 1  4/58 (6.90%) 
Peripheral sensory neuropathy * 1  9/58 (15.52%) 
Psychiatric disorders   
Anxiety * 1  4/58 (6.90%) 
Depressed mood * 1  3/58 (5.17%) 
Insomnia * 1  4/58 (6.90%) 
Renal and urinary disorders   
Dysuria * 1  4/58 (6.90%) 
Haemorrhage urinary tract * 1  5/58 (8.62%) 
Micturition urgency * 1  3/58 (5.17%) 
Nocturia * 1  4/58 (6.90%) 
Pollakiuria * 1  4/58 (6.90%) 
Urinary incontinence * 1  3/58 (5.17%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  5/58 (8.62%) 
Dyspnoea * 1  10/58 (17.24%) 
Productive cough * 1  3/58 (5.17%) 
Skin and subcutaneous tissue disorders   
Ecchymosis * 1  4/58 (6.90%) 
Vascular disorders   
Hot flush * 1  6/58 (10.34%) 
Hypertension * 1  3/58 (5.17%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director, Clinical Research
Organization: Janssen Research & Development, 10990 Wilshire Blvd, Suite 1200, Los Angeles, California 90024
Phone: (310) 943-8040 ext 2917
Layout table for additonal information
Responsible Party: Cougar Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00485303    
Other Study ID Numbers: CR016921
COU-AA-004
2007-002725-74 ( EudraCT Number )
First Submitted: June 8, 2007
First Posted: June 12, 2007
Results First Submitted: April 23, 2013
Results First Posted: June 17, 2013
Last Update Posted: July 2, 2013