Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cougar Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT00638690
First received: March 13, 2008
Last updated: February 26, 2014
Last verified: February 2014
Results First Received: August 23, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Prostatic Neoplasms
Interventions: Drug: Placebo
Drug: Abiraterone acetate
Drug: Prednisone/prednisolone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Abiraterone Acetate Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
Placebo Placebo plus prednisone/prednisolone administered as four placebo tablets once daily plus 5 mg prednisone/5 mg prednisolone tablet twice daily until disease progression.

Participant Flow:   Overall Study
    Abiraterone Acetate     Placebo  
STARTED     797     398  
COMPLETED     116     56  
NOT COMPLETED     681     342  
Death                 655                 335  
Withdrawal by Subject                 22                 5  
Lost to Follow-up                 4                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Abiraterone Acetate Abiraterone acetate plus prednisone/prednisolone administered as four 250 mg tablets of abiraterone acetate once daily plus 5 mg prednisone/5 mg prednisolone twice daily until disease progression.
Placebo Placebo plus prednisone/prednisolone
Total Total of all reporting groups

Baseline Measures
    Abiraterone Acetate     Placebo     Total  
Number of Participants  
[units: participants]
  797     398     1195  
Age  
[units: years]
Mean ± Standard Deviation
  69.1  ± 8.4     68.9  ± 8.61     69  ± 8.46  
Gender  
[units: participants]
     
Female     0     0     0  
Male     797     398     1195  
Region of Enrollment  
[units: participants]
     
Australia     69     35     104  
Austria     11     1     12  
Belgium     32     11     43  
Canada     97     57     154  
France     57     33     90  
Germany     26     12     38  
Hungary     5     2     7  
Italy     21     12     33  
Netherlands     4     2     6  
Republic of Ireland     7     7     14  
Spain     13     3     16  
United Kingdom     119     61     180  
United States     336     162     498  



  Outcome Measures
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1.  Primary:   Overall Survival   [ Time Frame: Up to 60 months ]

2.  Secondary:   Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria   [ Time Frame: Up to 12 months ]

3.  Secondary:   Number of Patients Achieving a Prostate-Specific Antigen Decline >=50%   [ Time Frame: Up to 12 months ]

4.  Secondary:   Radiographic Progression-free Survival   [ Time Frame: Up to 11 months ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.
The agreement is:
unchecked 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.
unchecked 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Senior Director, Clinical Research
Organization: Johnson & Johnson Pharmaceutical Research & Development
phone: 310-914-2915 ext NA


No publications provided by Cougar Biotechnology, Inc.

Publications automatically indexed to this study:


Responsible Party: Cougar Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00638690     History of Changes
Other Study ID Numbers: CR016924, COU-AA-301
Study First Received: March 13, 2008
Results First Received: August 23, 2011
Last Updated: February 26, 2014
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Australia: National Health and Medical Research Council
Canada: Health Canada