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COMPLETED
NCT04736199
PHASE3

Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer

Sponsor: Bayer

View on ClinicalTrials.gov

Summary

The purpose of the study is to assess the efficacy and safety of darolutamide in combination with standard androgen deprivation therapy (ADT) in patients with metastatic hormone sensitive prostate cancer.

Official title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide in Addition to Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Men With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

669

Start Date

2021-02-23

Completion Date

2026-01-23

Last Updated

2026-09-29

Healthy Volunteers

No

Interventions

DRUG

Darolutamide (Nubeqa, BAY1841788)

Coated tablet, oral administration

DRUG

Placebo

Coated tablet matching Darolutamide in appearance, oral administration

OTHER

Androgen deprivation therapy (ADT)

Luteinizing hormone-releasing hormone (LHRH) agonist/antagonists or orchiectomy

Locations (131)

Nepean Hospital

Kingswood, New South Wales, Australia

Northern Cancer Institute

St Leonards, New South Wales, Australia

Macquarie University Hospital - Oncology Department

Sydney, New South Wales, Australia

Cancer Research South Australia

Adelaide, South Australia, Australia

Peninsula Oncology Centre

Frankston, Victoria, Australia

Austin Health

Heidelberg, Victoria, Australia

Assistência Multidisciplinar em Oncologia (AMO)

Salvador, Estado de Bahia, Brazil

Hosp. Araujo Jorge da Associação de Combate ao Câncer

Goiânia, Goiás, Brazil

Hospital da Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Cetus Oncologia Hospital Dia

Belo Horizonte, Minas Gerais, Brazil

Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner

Curitiba, Paraná, Brazil

Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica

Natal, Rio Grande do Norte, Brazil

Unidade de Pesquisas Clinicas em Oncologia

Pelotas, Rio Grande do Sul, Brazil

Santa Casa de Porto Alegre | Hospital Sao Francisco - Centro Medico Pesquisa Clinica Cardiologia

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Mae de Deus

Porto Alegre, Rio Grande do Sul, Brazil

FZ Pesquisa e Servicos em Cardiologia | Porto Alegre, Brazil

Porto Alegre, Rio Grande do Sul, Brazil

Fundacao Pio XII - Hospital de Cancer de Barretos

Barretos/SP, São Paulo, Brazil

Hospital de Base | Funfarme - Centro Integrado de Pesquisa - Cardiologia

São José do Rio Preto, São Paulo, Brazil

Urobrasil

São Paulo, São Paulo, Brazil

IBCC - Instituto Brasileiro de Controle do Cancer

São Paulo, São Paulo, Brazil

Inst. de Assistência Médica ao Sérvidor Público Estadual

São Paulo, São Paulo, Brazil

Instituto COI de Educação e Pesquisa

Rio de Janeiro, Brazil

G. Kenneth Jansz Medicine Professional Corporation

Burlington, Ontario, Canada

Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)

Montreal, Quebec, Canada

Centro de Investigación Clínica del Sur

Temuco, Araucania, Chile

Centro de Estudios Clínicos SAGA SpA

Providencia, Santiago Metropolitan, Chile

OncoCentro

Viña del Mar, Valparaiso, Chile

Fundación Arturo López Perez

Santiago, Chile

Oncovida

Santiago, Chile

Hospital Clínico de la Pontificia Univ. Católica de Chile

Santiago, Chile

UROMED

Santiago, Chile

Anhui Provincial Hospital

Hefei City, Anhui Province, Anhui, China

Beijing Hospital

Beijing, Beijing Municipality, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Guangzhou First People Hospital

Guangzhou, Guangdong, China

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, Guangdong, China

Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.

Wuhan, Hubei, China

Zhongnan hospital ,Wuhan University

Wuhan, Hubei, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Hunan Cancer Hospital - Oncology Department

Changsha, Hunan, China

NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School

Nanjing, Jiangsu, China

Nantong tumor hospital

Nantong, Jiangsu, China

The 2nd Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

1st Hospital of Jilin University

Changchun, Jilin, China

Liaoning Cancer Hospital and Institute

Shengyang, Liaoning, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

SichuanAcademyofMedicalSciences&SichuanProvincialPeople'sHos

Chengdu, Sichuan, China

Sichuan University West China Hospital

Chengdu, Sichuan, China

The 1st Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

ZheJiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Ningbo First Hospital

Ningbo, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

Peking University Third Hospital

Beijing, China

Beijing Cancer Hospital

Beijing, China

Mahatma Gandhi Cancer Hospital & Research Institute

Visakhapatnam, Andhra Pradesh, India

The Gujarat Cancer & Research Institute

Ahmedabad, Gujarat, India

HCG Cancer Centre - Ahmedabad

Ahmedabad, Gujarat, India

Cancer Care Clinic - Vadodara

Vadodara, Gujarat, India

K.L.E.S. Dr. Prabhakar Kore Hospital & Medical Research Centre

Belagavi, Karnataka, India

Healthcare Global Enterprises Ltd

Bengaluru, Karnataka, India

Amrita Institute of Medical Sciences

Kochi, Kerala, India

Regional Cancer Centre - Thiruvananthapuram

Thiruvananthapuram, Kerala, India

Marathwada Regional Cancer Centre and Research Institute

Aurangabad, Maharashtra, India

Jaslok Hospital and Research Centre

Mumbai, Maharashtra, India

Curie Manavata Cancer Centre

Nashik, Maharashtra, India

Jehangir Hospital

Pune, Maharashtra, India

Sparsh Hospital & Critical Care

Bhubaneswar, Odisha, India

All India Institute of Medical Sciences

Bhubaneswar, Odisha, India

Jawaharlal Institute Of Postgraduate Medical Education and R

Gorimedu, Puducherry, India

Christian Medical Center & Hospital

Ludhiana, Punjab, India

Sawami Man Singh (SMS) Medical College & Attached Hospitals

Jaipur, Rajasthan, India

Apollo Speciality Hospitals

Madurai, Tamil Nadu, India

Meenakshi Mission Hospital & Research Centre

Madurai, Tamil Nadu, India

Post Graduate Institute of Medical Education and Research

Chandigarh, India

Tata Medical Center

Kolkata, India

Apex Wellness Hospital

Nashik, India

Rajiv Gandhi Cancer Institute & Research Centre

New Delhi, India

Daugavpils Regional Hospital

Daugavpils, Latvia

RAKUS Hospital Gailezers

Riga, Latvia

URO Ltd.

Riga, Latvia

P. Stradins Clinical University Hospital

Riga, Latvia

Vidzemes Hospital

Valmiera, Latvia

The Hospital of Lithuanian University of Health SciencesLUHS

Kaunas, Lithuania

PI Klaipedos University Hospital

Klaipėda, Lithuania

National Cancer Institute

Vilnius, Lithuania

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

Tauranga Urology Research Limited

Tauranga, Bay of Plenty, New Zealand

Canterbury Urology Research Trust

Christchurch, Canterbury, New Zealand

Waikato Hospital

Hamilton, Waikato Region, New Zealand

Aliada

San Isidro, Lima region, Peru

Hospital Guillermo Almenara Irigoyen

Santiago de Surco, Lima region, Peru

Hospital Militar Luis Arias Schreiber

Lima, Peru

Clínica El Golf

Lima, Peru

Arkhangelsk Clinical Oncology Dispensary

Arkhangelsk, Russia

Ltd "EVIMED"

Chelyabinsk, Russia

Chelyabinsk Regional Oncology Dispensary

Chelyabinsk, Russia

Ivanovo Regional Oncology Dispensary

Ivanovo, Russia

Republican Clinical Oncology Dispensary Kazan

Kazan', Russia

And 31 more locations on ClinicalTrials.gov