CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 75 enrolled
Drug / intervention
Enzalutamide +3 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/NCT02268175
NCT02268175Phase 2Completed

A Phase II Randomized Study of Enzalutamide+Leuprolide Versus Enzalutamide+Leuprolide+Abiraterone Acetate+Prednisone as Neoadjuvant Therapy for HIgh-Risk Prostate Cancer Undergoing Prostatectomy

Dana-Farber Cancer Institute·interventional·Posted Oct 20, 2014·Updated Apr 19, 2022

In Brief

A Phase 2 clinical trial evaluating Enzalutamide, Abiraterone Acetate, and 2 other interventions for Prostate Adenocarcinoma and 2 related conditions. Completed, enrolled 75 participants across 4 sites.

Detailed Summary

This study is comparing the effectiveness of enzalutamide with or without abiraterone acetate for men with high-risk, localized prostate cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsMedivation, Inc.

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 20, 2014
Enrollment StartOct 1, 2014
Primary CompletionJan 1, 2018
Study CompletionDec 1, 2021
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 11.7 years ago

Interventions

Enzalutamidedrug

160 mg (four 40 mg capsules), oral, once daily, 28 days (4 weeks) 6 cycles maximum. Can be taken with or without food.

Abiraterone Acetatedrug

1000 mg (four 250 mg tablets), oral, once daily, 28 days (4 weeks) 6 cycles maximum. No food should be consumed for at least two hours before the dose and for at least one hour after the dose.

Prednisonedrug

5 mg, oral, once daily, 28 days (4 weeks) 6 cycles maximum.Take with food, preferred to be taken in the morning .

Leuprolide Acetatedrug

Either 7.5 mg monthly or 22.5 mg every three months, Intramuscular, monthly or every three months.