CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
enzalutamidedrug
Likely dose
enzalutamide 160mgfrom 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/NCT01927627
NCT01927627Phase 2Completed
CompareCT.gov

A Phase 2 Study of Enzalutamide in Patients With High-risk Prostate Cancer Who Have Undergone Local Definitive Therapy With Radical Prostatectomy

Case Comprehensive Cancer Center·interventional·Posted Aug 22, 2013·Updated Mar 20, 2019

In Brief

A Phase 2 clinical trial evaluating enzalutamide for Adenocarcinoma of the Prostate. Completed, enrolled 42 participants across 1 site.

Detailed Summary

The purpose of this study is to see how long it takes for prostate cancer to come back in patients who have had surgery to remove their prostate gland (radical prostatectomy), while being treated with enzalutamide (formerly known as MDV3100). Enzalutamide is known as an androgen-receptor signaling inhibitor, which means that it blocks activity of the male hormone, testosterone. Most prostate cancers are dependent on testosterone for growth. In this study, patients will take enzalutamide after surgery to see if it keeps their cancer from coming back.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdenocarcinoma of the Prostate
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 22, 2013
Enrollment StartNov 11, 2013
Primary CompletionMar 29, 2017
Study CompletionApr 26, 2017
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 12.9 years ago

Interventions

enzalutamidedrug

oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD).