CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 69 enrolled
Drug / intervention
Abiraterone Acetate +3 moredrug
Likely dose
Abiraterone Acetate 1,000 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/NCT01946165
NCT01946165Phase 2Completed
CompareCT.gov

A Pre-Operative Study to Assess the Effects of Abiraterone Acetate Plus LHRH Agonist and Abiraterone Acetate Plus LHRH Agonist and Enzalutamide for Six Months for Prostate Cancer Patients at High-Risk for Recurrence

M.D. Anderson Cancer Center·interventional·Posted Sep 19, 2013·Updated Dec 6, 2019

In Brief

A Phase 2 clinical trial evaluating Abiraterone Acetate, Prednisone, and 2 other interventions for Prostate Cancer. Completed, enrolled 69 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if adding the combination of abiraterone acetate and prednisone with or without enzalutamide to hormonal therapy can help to control prostate cancer when given before surgery. The safety of the drug combination will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsJanssen Services, LLC, Medivation, Inc.

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 19, 2013
Enrollment StartOct 31, 2013
Primary CompletionJul 28, 2017
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 12.8 years ago

Interventions

Abiraterone Acetatedrug

1,000 mg by mouth daily for each 28 day cycle.

Prednisonedrug

5 mg by mouth once daily for each 28 day cycle.

Enzalutamidedrug

160 mg by mouth daily for each 28 day cycle.

LHRHadrug

Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.