CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 64 enrolled
Drug / intervention
Enzalutamide +1 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/NCT02028988
NCT02028988Phase 2Completed

Enzalutamide With External Beam Radiation for Intermediate Risk Prostate Cancer: A Phase II Study

Dana-Farber Cancer Institute·interventional·Posted Jan 7, 2014·Updated May 6, 2023

In Brief

A Phase 2 clinical trial evaluating Enzalutamide and External Beam Radiation for Intermediate Risk Prostate Cancer. Completed, enrolled 64 participants across 3 sites.

Detailed Summary

This research study is evaluating a drug called enzalutamide in combination with external beam radiation therapy as a possible treatment for prostate cancer. Presently, when participants receive hormonal therapy with radiation therapy for prostate cancer, medications are given to reduce testosterone levels in the blood stream. This leads to side effects such as loss of sex drive, erectile dysfunction (ED) and decrease in muscle strength. The purpose of this study is test another form of hormonal therapy with radiation therapy. The medication called enzalutamide will be used with radiation therapy. Instead of lowering testosterone, enzalutamide blocks testosterone in cells. This study will test if enzalutamide when used with radiation will lower the PSA without causing the side effects associated with medications that lower testosterone in the blood stream.

Study Details

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

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 7, 2014
Enrollment StartFeb 1, 2014
Primary CompletionOct 1, 2017
Study CompletionJan 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 12.5 years ago

Interventions

Enzalutamidedrug

External Beam Radiationradiation