IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen - Study Results

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

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	Participants were given Abiraterone Acetate 1000 milligram (mg) (4250 mg) tablets and Prednisone 5 mg (22.5 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.

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

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
Abiraterone Acetate	Participants were given Abiraterone Acetate 1000 milligram (mg) (4250 mg) tablets and Prednisone 5 mg (22.5 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.

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
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) ]

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2. Secondary:

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

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3. Secondary:

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

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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) ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days. The sponsor will not mandate modifications to scientific content and does not have the right to suppress information.

Results Point of Contact:

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

Responsible Party:	Janssen Biotech, Inc.
ClinicalTrials.gov Identifier:	NCT01314118 History of Changes
Other Study ID Numbers:	CR017932 Protocol 212082PCR2005 ( Other Identifier: Janssen Biotech Inc. )
Study First Received:	March 4, 2011
Results First Received:	December 24, 2014
Last Updated:	May 13, 2016
Health Authority:	United States: Food and Drug Administration United States: Federal Government United States: Institutional Review Board