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NCT01088529 · ClinicalTrials.gov registry record · Phase 2
Neo-adjuvant Abiraterone + Luteinizing Hormone-Releasing Hormone (LHRH) Versus LHRH in Prostate Cancer
A Phase 2 study, sponsored by Cougar Biotechnology.
- Completed
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
NCT01088529: Completed Phase 2 study, sponsored by Cougar Biotechnology.
NCT01088529 is a Phase 2 study that has completed, run by Cougar Biotechnology. The registered enrollment target is 66 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01088529, a Phase 2 study, has completed, sponsored by Cougar Biotechnology.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find out how treatment with abiraterone acetate in combination with prednisone and a Luteinizing Hormone-Releasing Hormone (LHRH) analogue changes the tumor in comparison to treatment with an LHRH analogue alone. Objectives: Primary Objective: To assess the difference in pathologic stage \< pT2 between Group A and Group B. Secondary Objective: * To assess and compare the changes in levels of androgens (pre, during, and post treatment) in the serum, primary tumor microenvironment and bone marrow between Group A and Group B. * To assess changes in biomarkers related to androgen signaling and other cancer-related pathways between Group A and Group B. * To assess the difference in rate of positive surgical margins between Group A and Group B. * To assess the safety profile of abiraterone acetate and low dose prednisone in a preoperative setting.
Primary Outcome
The table below shows number of participants in each treatment group with a pathology tumor stage less than or equal to pT2.
Interventions
- DRUG Prednisone
- DRUG Abiraterone Acetate
- DRUG LHRHa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2009-12 |
| Est. Completion | 2013-03 |
| Phase | Phase 2 |
What the finished NCT01088529 record still lists
NCT01088529 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 3 interventions - of which Prednisone is the first listed.
NCT01088529 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01088529 about?
NCT01088529 is a clinical study titled "Neo-adjuvant Abiraterone + Luteinizing Hormone-Releasing Hormone (LHRH) Versus LHRH in Prostate Cancer". The goal of this clinical research study is to find out how treatment with abiraterone acetate in combination with prednisone and a Luteinizing Hormone-Releasing Hormone (LHRH) analogue changes the tumor in comparison to treatment with an LHRH analogue alone. Objectives: Primary Objective: To ass...
What is the current status of trial NCT01088529?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2009-12. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01088529?
The interventions under investigation include: Prednisone (DRUG), Abiraterone Acetate (DRUG), LHRHa (DRUG).
Who is sponsoring clinical trial NCT01088529?
This trial is sponsored by Cougar Biotechnology, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01088529's enrollment target sits among peer trials
66 975th of 2000 higher than 1,014 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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