OncRef

Clinical Trial: NCT02677896

A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Astellas Pharma Global Development, Inc.
Information Provided By:Astellas Pharma Inc
Last Update Posted:2025-10-24

Study Overview

Brief 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.

Official Title

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)

Conditions

Metastatic Hormone Sensitive Prostate Cancer

Intervention / Treatment

  • Drug: Enzalutamide
  • Drug: Placebo

Other Study ID Numbers

  • 9785-CL-0335
  • 2015-003869-28
  • 2015

Start Date (Actual)

2016-03-09

Primary Completion Date (Actual)

2018-10-14

Study Completion Date (Actual)

2024-07-31

Enrollment (Actual)

1150

Study Type

Interventional

Phase

Phase 3