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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 is a Phase 2 study that has completed, run by Cougar Biotechnology. The registered enrollment target is 66 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01088529
The ClinicalTrials.gov registry entry for NCT01088529 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cougar Biotechnology, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Prednisone is the first listed.
NCT01088529 reports 0 study locations.
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.
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