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NCT00924469 · ClinicalTrials.gov registry record · Phase 2

A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone Acetate in Male Participants With Prostate Cancer

A Phase 2 study, sponsored by Janssen Research & Development.

Completed
Registry status
Phase 2
Development phase
58
Enrollment target

NCT00924469: Completed Phase 2 study, sponsored by Janssen Research & Development.

NCT00924469 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 58 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00924469, a Phase 2 study, has completed, sponsored by Janssen Research & Development.

COMPLETED
Registry status
Phase 2
Development phase
58 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate safety and efficacy of abiraterone acetate plus leuprolide acetate and prednisone, versus leuprolide acetate alone in male participants with prostate cancer (a disease in which cells in the prostate gland become abnormal and start to grow uncontrollably, forming tumors) who are suitable candidates for prostatectomy (surgery to remove all or part of the prostate gland).

Primary Outcome

Testosterone is a potent androgen (a hormone that promotes the development and maintenance of male characteristics) and major product secreted by cells in the testis and produced in the adrenal glands and by prostate cancers. Abiraterone acetate affects sources of testosterone in the body (ie, adrendal gland and prostate tumor). Testosterone concentration was measured in prostate tissues after exposure to study treatments at Week 12.

Interventions

  • DRUG Prednisone
  • DRUG Abiraterone
  • DRUG Leuprolide

Trial Details

FieldValue
Enrollment Target 58 participants
Start Date 2009-11
Est. Completion 2012-03
Phase Phase 2
Janssen Research & Development

593 total trials

What the finished NCT00924469 record still lists

NCT00924469 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).

The record links to 0 conditions, and to 3 interventions - of which Prednisone is the first listed.

NCT00924469 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00924469 about?

NCT00924469 is a clinical study titled "A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone Acetate in Male Participants With Prostate Cancer". The purpose of this study is to evaluate safety and efficacy of abiraterone acetate plus leuprolide acetate and prednisone, versus leuprolide acetate alone in male participants with prostate cancer (a disease in which cells in the prostate gland become abnormal and start to grow uncontrollably, form...

What is the current status of trial NCT00924469?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2009-11. Estimated completion is 2012-03.

What interventions are being tested in trial NCT00924469?

The interventions under investigation include: Prednisone (DRUG), Abiraterone (DRUG), Leuprolide (DRUG).

Who is sponsoring clinical trial NCT00924469?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00924469's enrollment target sits among peer trials

58 1135th of 2000 higher than 860 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00924469, the US trial registry maintained by the National Library of Medicine. NCT00924469 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.