NCT02677896

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,150 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Following unblinding at the end of the double-blind period and demonstration of a statistically significant advantage of enzalutamide over placebo when added to ADT as assessed by the primary endpoint of rPFS, subjects were eligible to transition to an open-label portion of the study.

Conditions

• Metastatic Hormone Sensitive Prostate Cancer

Interventions

Type	Name	Description
DRUG	Enzalutamide	Oral
DRUG	Placebo	Oral

Timeline

• Start date: 2016-03-09
• Primary completion: 2018-10-14
• Completion: 2024-07-31
• First posted: 2016-02-09
• Last updated: 2025-10-24
• Results posted: 2020-01-21

Locations

203 sites across 24 countries: United States, Argentina, 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

Regulatory

• FDA-regulated drug study