CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
abiraterone acetatedrug
Likely dose
Not stated in 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/NCT02025010
NCT02025010Phase 2Completed

Phase II Clinical Trial of Abiraterone Acetate Without Exogenous Glucocorticoids in Men With Castration-resistant Prostate Cancer With Correlative Assessment of Hormone Intermediates.

Dana-Farber Cancer Institute·interventional·Posted Dec 31, 2013·Updated Apr 15, 2025

In Brief

A Phase 2 clinical trial evaluating abiraterone acetate for Castration-resistant Prostate Cancer. Completed, enrolled 60 participants across 8 sites.

Detailed Summary

This study is comparing the safety and effectiveness of abiraterone acetate alone, followed by the addition of prednisone (when the participant's disease worsens or the physician feels it would lessen symptoms of toxicity) versus the current approved treatment regimen which involves the concomitant use of prednisone in conjunction with abiraterone acetate. Additionally, this study is also examining why participants stop responding to treatment with abiraterone acetate by evaluating blood and tissue.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 31, 2013
Enrollment StartJan 27, 2014
Primary CompletionDec 1, 2021
Study CompletionApr 7, 2025
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 12.5 years ago

Interventions

abiraterone acetatedrug

Abiraterone acetate is a selective and irreversible inhibitor of CYP17 which has demonstrated clinical efficacy in patients with CRPC. Currently, AA is administered with concomitant prednisone.