drugset / Trial / NCT04076059

An Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Chinese Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

NCT04076059

Phase 3 Active not recruiting 180 enrolled Astellas Pharma Inc
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study was to evaluate the efficacy and safety of enzalutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT in Chinese subjects with metastatic hormone sensitive prostate cancer (mHSPC). The study was conducted in two phases: Double-Blind treatment phase and open-label phase.

Timeline

Start
2019-09-11
Primary completion
2022-11-18
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Enzalutamide Other / unclassified 160 mg Oral