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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: April 10, 2014
Last verified: April 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
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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 
Overall Participants Analyzed 
[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


  Limitations and Caveats
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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
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  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.


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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Cougar Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00638690     History of Changes
Other Study ID Numbers: CR016924
COU-AA-301 ( Other Identifier: Cougar Biotechnology, Inc )
Study First Received: March 13, 2008
Results First Received: August 23, 2011
Last Updated: April 10, 2014
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Australia: National Health and Medical Research Council
Canada: Health Canada