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Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer
Sponsor: Bayer
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
Conditions
Interventions
Darolutamide (Nubeqa, BAY1841788)
Coated tablet, oral administration
Placebo
Coated tablet matching Darolutamide in appearance, oral administration
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