CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 66 enrolled
Drug / intervention
Abiraterone Acetate +2 moredrug
Likely dose
Abiraterone Acetate 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01088529
NCT01088529Phase 2Completed
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A Randomized, Open-Label, Neoadjuvant Prostate Cancer Trial of Abiraterone Acetate Plus LHRHa Versus LHRHa Alone

Cougar Biotechnology, Inc.·interventional·Posted Mar 17, 2010·Updated May 15, 2014

In Brief

A Phase 2 clinical trial evaluating Abiraterone Acetate, Prednisone, and 1 other intervention for Prostate Cancer. Completed, enrolled 66 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 17, 2010
Enrollment StartDec 1, 2009
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 16.3 years ago

Interventions

Abiraterone Acetatedrug

1000 mg oral daily for 3 months followed by a prostatectomy.

Prednisonedrug

5 mg orally daily.

LHRHadrug

LHRH analogue (either leuprolide or goserelin): Leuprolide is an intramuscular injection, and goserelin subcutaneous (under skin) of abdomen, given either 1 injection every 3 months or 1 injection each month for 3 months.