IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen

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 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
STARTED	131
COMPLETED	0
NOT COMPLETED	131
Adverse Event	9
Progressive disease	27
Physician Decision	11
Death	4
Protocol Violation	5
Withdrawal by Subject	11
Unspecified	2
Ongoing	62

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

Abiraterone Acetate

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.

Baseline Measures

	Abiraterone Acetate
Overall Participants Analyzed  [Units: Participants]	131
Age  [Units: Years] Mean (Standard Deviation)	71.2  (8.82)
Sex: Female, Male  [Units: Participants] Count of Participants
Female	0   0.0%
Male	131 100.0%
Region of Enrollment  [Units: Participants]
USA	131

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) ]

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.