CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 180 enrolled
Drug / intervention
Enzalutamide +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT04076059
NCT04076059Phase 3Active
CompareCT.gov

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)

Astellas Pharma China, Inc.·interventional·Posted Sep 3, 2019·Updated Apr 17, 2026

In Brief

A Phase 3 clinical trial evaluating Enzalutamide, Placebo, and 1 other intervention for Metastatic Hormone Sensitive Prostate Cancer. Active but no longer recruiting, targeting 180 participants across 28 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Hormone Sensitive Prostate Cancer
CountriesChina
Collaborators--

Timeline

Phase 3Active
2020202120222023202420252026202720282029
First PostedSep 3, 2019
Enrollment StartSep 11, 2019
Primary CompletionNov 18, 2022
Study CompletionDec 31, 2028
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 6.8 years ago

Interventions

Enzalutamidedrug

Oral

Placebodrug

Oral

Androgen deprivation therapy (ADT)drug

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.