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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00887198
First received: April 18, 2009
Last updated: August 6, 2015
Last verified: August 2015
Results First Received: March 30, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: Abiraterone acetate
Drug: Placebo
Drug: Prednisone

  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
No text entered.

Reporting Groups
  Description
Abiraterone Acetate 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.
Placebo 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.

Participant Flow:   Overall Study
    Abiraterone Acetate     Placebo  
STARTED     546     542  
COMPLETED     162     111  
NOT COMPLETED     384     431  
Death                 352                 387  
Withdrawal by Subject                 28                 41  
Lost to Follow-up                 4                 3  



  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.
Analysis population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.

Reporting Groups
  Description
Abiraterone Acetate 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.
Placebo 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 Total of all reporting groups

Baseline Measures
    Abiraterone Acetate     Placebo     Total  
Number of Participants  
[units: participants]
  546     542     1088  
Age  
[units: Years]
Mean (Standard Deviation)
  70.5  (8.8)     70.1  (8.72)     70.3  (8.76)  
Gender  
[units: Participants]
     
Female     0     0     0  
Male     546     542     1088  
Region of Enrollment  
[units: Participants]
     
Australia     60     72     132  
Belgium     25     17     42  
Canada     63     37     100  
France     24     29     53  
Germany     46     32     78  
Greece     7     7     14  
Italy     1     6     7  
Netherlands     15     15     30  
Spain     25     20     45  
Sweden     4     13     17  
United Kingdom     42     56     98  
United States     234     238     472  



  Outcome Measures
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1.  Primary:   Overall Survival   [ Time Frame: From randomization (Day 1) up to end of study (Month 60) ]

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

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

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

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

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

7.  Secondary:   Number of Participants With Treatment Emergent Adverse Events   [ Time Frame: From first dose of study drug up to 30 days after the last dose of study drug ]

8.  Secondary:   Mean Plasma Concentrations of Abiraterone   [ Time Frame: Up to Cycle 5, Day 1 ]

9.  Secondary:   Maximum Plasma Concentrations of Abiraterone   [ Time Frame: Up to Cycle 5, Day 1 ]

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

11.  Secondary:   Elimination Half-Life (t1/2)   [ Time Frame: Up to Cycle 5, Day 1 ]


  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
These results are up to clinical cutoff (CCO) date (that is, 31 March 2014).


  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: Janssen R&D US
e-mail: ClinicalTrialDisclosure@its.jnj.com


No publications provided by Janssen Research & Development, LLC

Publications automatically indexed to this study:


Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT00887198     History of Changes
Other Study ID Numbers: CR016927, COU-AA-302, 2008-008004-41
Study First Received: April 18, 2009
Results First Received: March 30, 2015
Last Updated: August 6, 2015
Health Authority: United States: Food and Drug Administration