CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
Enzalutamide +2 moredrug
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/NCT02256111
NCT02256111Phase 2Completed

EXTEND: Safety and Efficacy of EXercise Training in Men Receiving ENzalutamide in Combination With Conventional Androgen Deprivation Therapy for Hormone Naïve Prostate Cancer

Duke University·interventional·Posted Oct 3, 2014·Updated Apr 18, 2019

In Brief

A Phase 2 clinical trial evaluating Enzalutamide, Androgen deprivation therapy, and 1 other intervention for Non-metastatic, Hormone naïve Prostate Cancer. Completed, enrolled 26 participants across 2 sites.

Detailed Summary

This study will examine the effect of supervised exercise training on cardiopulmonary function in men receiving the combination of enzalutamide (ENZ) and androgen deprivation therapy (ADT) for treatment of non-metastatic, hormone-naïve prostate cancer. No study to date has examined the efficacy, tolerability, and safety of exercise training to prevent and/or mitigate common adverse toxicities in men receiving combination androgen suppression therapy for hormone-naïve prostate cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 3, 2014
Enrollment StartMay 13, 2015
Primary CompletionFeb 21, 2018
Study CompletionJul 17, 2018
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 11.7 years ago

Interventions

Enzalutamidedrug

Androgen deprivation therapydrug

Supervised exercise trainingbehavioral