IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janssen Biotech, Inc.
ClinicalTrials.gov Identifier:
NCT01314118
First received: March 4, 2011
Last updated: June 26, 2015
Last verified: June 2015
Results First Received: December 24, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Prostate Cancer
Prostatic Neoplasm
Intervention: Drug: abiraterone acetate in combination with 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 and Prednisone Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator’s decision, and withdrawal by participant or until the sponsor decided to stop the trial.

Participant Flow:   Overall Study
    Abiraterone Acetate and Prednisone  
STARTED     131  
COMPLETED     0 [1]
NOT COMPLETED     131  
Adverse Event                 9  
Physician Decision                 7  
Protocol Violation                 2  
Withdrawal by Subject                 6  
Progressive Disease                 14  
Unspecified                 8  
Death                 4  
Ongoing                 81  
[1] Partician



  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.
All participants who received at least 1 dose of study drug.

Reporting Groups
  Description
Overall Study Population All participants who received at least 1 dose of study drug.

Baseline Measures
    Overall Study Population  
Number of Participants  
[units: participants]
  131  
Age  
[units: years]
Mean (Standard Deviation)
  71.2  (8.82)  
Gender  
[units: participants]
 
Female     0  
Male     131  
Region of Enrollment  
[units: participants]
 
USA     131  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) During the Core Study   [ Time Frame: End of core study visit (Approximately at Month 6) ]

2.  Secondary:   Time to Radiographic Evidence of Disease Progression (TTRP)   [ Time Frame: Maximum up to Month 30.5 ]

3.  Secondary:   Time to Prostate-Specific Antigen (PSA) Progression   [ Time Frame: Maximum up to Month 30.5 ]

4.  Secondary:   Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) Levels After 3 Cycles of Treatment   [ Time Frame: End of Cycle 3 (Approximately Month 3) ]


  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 31 December 2013 when all enrolled subjects either completed 6 cycles of treatment or withdrew from study prior to end of cycle 6. Primary endpoint results are complete.


  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: Strategic Lead Oncology Tas
Organization: Janssen Services, LLC
e-mail: ClinicalTrialDisclosure@its.jnj.com


No publications provided


Responsible Party: Janssen Biotech, Inc.
ClinicalTrials.gov Identifier: NCT01314118     History of Changes
Other Study ID Numbers: CR017932, Protocol 212082PCR2005
Study First Received: March 4, 2011
Results First Received: December 24, 2014
Last Updated: June 26, 2015
Health Authority: United States: Food and Drug Administration
United States: Federal Government
United States: Institutional Review Board