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)

China ARCHES: A Multicenter, Phase 3, Randomized, Double-blind, Placebo Controlled 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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Astellas Pharma China, Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Hormone Sensitive Prostate Cancer

Interventions

Type	Name	Description
DRUG	Enzalutamide	Oral
DRUG	Placebo	Oral
DRUG	Androgen deprivation therapy (ADT)	All participants were required to maintain ADT during study treatment, either using luteinizing hormone-releasing hormone (LHRH) agonist/antagonist or having a history of bilateral orchiectomy.

Timeline

• Start date: 2019-09-11
• Primary completion: 2022-11-18
• Completion: 2028-12-31
• First posted: 2019-09-03
• Last updated: 2026-04-17
• Results posted: 2023-11-18

Locations

28 sites across 1 country: China

Regulatory

• FDA-regulated drug study