NCT04076059View on ClinicalTrials.gov

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)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

September 11, 2019

Primary Completion Date

November 18, 2022

Study Completion Date

December 31, 2028

Conditions
Metastatic Hormone Sensitive Prostate Cancer
Interventions
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.

Trial Locations (28)

Unknown

Site CN86022, Beijing

Site CN86035, Beijing

Site CN86024, Changchun

Site CN86009, Changsha

Site CN86016, Changsha

Site CN86023, Changsha

Site CN86025, Fuzhou

Site CN86001, Guangzhou

Site CN86028, Hangzhou

Site CN86036, Hangzhou

Site CN86004, Nanchang

Site CN86002, Shanghai

Site CN86003, Shanghai

Site CN86010, Shanghai

Site CN86013, Shanghai

Site CN86014, Shanghai

Site CN86027, Shanghai

Site CN86020, Shenyang

Site CN86011, Shenzhen

Site CN86032, Suzhou

Site CN86012, Tianjin

Site CN86005, Ürümqi

Site CN86019, Wuhan

Site CN86026, Wuhan

Site CN86021, Wuxi

Site CN86038, Xi'an

Site CN86017, Zhengzhou

Site CN86029, Zhengzhou

All Listed Sponsors
lead

Astellas Pharma China, Inc.

INDUSTRY