CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,150 enrolled
Drug / intervention
Enzalutamide +1 moredrug
Likely dose
Enzalutamide oral (dose not specified in published protocol excerpt)AI-extracted
Key inclusion· 4
  • ✓Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell histology
  • ✓Metastatic disease documented by positive bone scan, CT, or MRI (soft tissue metastases); regional pelvic lymph nodes only are not eligible
  • ✓Must maintain ADT with LHRH agonist or antagonist, or have history of bilateral orchiectomy
  • ✓ECOG performance status 0 or 1
Key exclusion· 9
  • ✕Prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate cancer (with specified exceptions for limited ADT, docetaxel, and palliative radiation/surgery)
  • ✕Prior aminoglutethimide, ketoconazole, abiraterone acetate, or enzalutamide for prostate cancer; prior AR inhibitor or androgen synthesis inhibitor clinical trial participation
  • ✕Known or suspected brain metastasis or active leptomeningeal disease
  • ✕ANC <1500/μL, platelets <100,000/μL, or hemoglobin <10 g/dL

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02677896
NCT02677896Phase 3Completed
CompareCT.gov

A Multinational, Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

Astellas Pharma Global Development, Inc.·interventional·Posted Feb 9, 2016·Updated Oct 24, 2025

In Brief

A Phase 3 clinical trial evaluating Enzalutamide and Placebo for Metastatic Hormone Sensitive Prostate Cancer. Completed, enrolled 1,150 participants across 203 sites in 24 countries.

Detailed Summary

The purpose of this study was to evaluate the efficacy of enzalutamide plus androgen deprivation therapy (ADT) as measured by radiographic progression-free survival (rPFS) based on central review. The study also evaluated the safety of enzalutamide plus ADT in mHSPC.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Hormone Sensitive Prostate Cancer
CountriesArgentina, Australia, Belgium, Canada, Chile, Denmark, Finland, France, Germany, Israel, Italy, Japan, Netherlands, New Zealand, Poland, Romania, Russia, Slovakia, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
CollaboratorsMedivation LLC, a wholly owned subsidiary of Pfizer Inc.

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 9, 2016
Enrollment StartMar 9, 2016
Primary CompletionOct 14, 2018
Study CompletionJul 31, 2024
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 10.4 years ago

Interventions

Enzalutamidedrug

Oral

Placebodrug

Oral