CI

At a glance

ClinicalIndex Comparison Record
Phase 3Unknown· 1,311 enrolled
Drug / intervention
enzalutamide +2 moredrug
Likely dose
enzalutamide 160 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/NCT01949337
NCT01949337Phase 3Unknown
CompareCT.gov

Phase III Trial of Enzalutamide (NSC# 766085) Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer

Alliance for Clinical Trials in Oncology·interventional·Posted Sep 24, 2013·Updated Sep 28, 2023

In Brief

A Phase 3 clinical trial evaluating enzalutamide, abiraterone, and 1 other intervention for Adenocarcinoma of the Prostate and 3 related conditions. Targeting 1,311 participants across 539 sites in 3 countries.

Detailed Summary

This randomized phase III trial studies enzalutamide to see how well it works compared to enzalutamide, abiraterone, and prednisone in treating patients with castration-resistant metastatic prostate cancer. Androgens can cause the growth of prostate cancer cells. Drugs, such as enzalutamide, abiraterone acetate, and prednisone, may lessen the amount of androgens made by the body.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdenocarcinoma of the Prostate, Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer, Stage IV Prostate Cancer
CountriesCanada, Puerto Rico, United States
CollaboratorsNational Cancer Institute (NCI), Astellas Pharma US, Inc., Medivation, Inc., Biologics, Inc.

Timeline

Phase 3UnknownOverdue
2014201520162017201820192020202120222023202420252026
First PostedSep 24, 2013
Enrollment StartJan 22, 2014
Primary CompletionNov 2, 2018
Study CompletionAug 31, 2024
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 12.8 years ago

Interventions

enzalutamidedrug

Enzalutamide 160 mg daily, orally

abirateronedrug

abiraterone 1000 mg daily, orally

prednisonedrug

prednisone 5 mg twice daily, orally