669
Participants
Start Date
February 23, 2021
Primary Completion Date
June 7, 2024
Study Completion Date
January 30, 2026
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
University of Pretoria, Clinical Research Unit, Pretoria
National Cheng Kung University Hospital, Tainan City
RAKUS Hospital Gailezers, Riga
East Rand Medical Research Unit, Johannesburg
Northern Cancer Institute, St Leonards
Macquarie University Hospital - Oncology Department, Sydney
Nepean Hospital, Kingswood
Austin Health, Heidelberg
Tauranga Urology Research Limited, Tauranga
Peninsula Oncology Centre, Frankston
Waikato Hospital, Hamilton
Kyiv Regional Oncological Dispensary, Kyiv
Cancer Research South Australia, Adelaide
Cancercare Langenhoven, Port Elizabeth
Cape Town Oncology Trials, Cape Town
Canterbury Urology Research Trust, Christchurch
Fundacio Puigvert - Urologia, Barcelona
Hospital San Pedro de Alcántara - Oncologia, Cáceres
Taipei Veterans General Hospital, Taipei
Hospital Guillermo Almenara Irigoyen, Santiago de Surco
Aliada, San Isidro
"CNE Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of the Cherkasy Regional Council", Cherkasy
Hospital Universitario Virgen De La Victoria - Urologia, Málaga
Hospital Universitario Fundacion Alcorcon - Urologia, Alcorcón
Taichung Veterans General Hospital, Taichung
Hospital Universitario Virgen Del Rocio S.L. - Urologia, Seville
City Dnipropetrovsk Multi- field Clinical Hosp. 4 DSMA, Dnipro
Changhua Christian Hospital, Changhua
Cancer Hospital, Chinese Academy of Medical Sciences, Beijing
Peking University Third Hospital, Beijing
Beijing Cancer Hospital, Beijing
Beijing Hospital, Beijing
Liaoning Cancer Hospital and Institute, Shengyang
Research Centre of X-ray and Radiology, Moscow
1st Hospital of Jilin University, Changchun
Christian Medical Center & Hospital, Ludhiana
Ivanovo Regional Oncology Dispensary, Ivanovo
Post Graduate Institute of Medical Education and Research, Chandigarh
Vologda Regional Hospital, Vologda
Arkhangelsk Clinical Oncology Dispensary, Arkhangelsk
AV Medical Group, Saint Petersburg
Russian Scientific Radiology and Surgery Technologies Center, Saint Petersburg
Scientific Research Instutute of Oncology n.a. N.N. Petrov, Saint Petersburg
NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School, Nanjing
The 2nd Affiliated Hospital of Soochow University, Suzhou
Nantong tumor hospital, Nantong
Anhui Provincial Hospital, Hefei City, Anhui Province
Yantai Yuhuangding Hospital, Yantai
Sawami Man Singh (SMS) Medical College & Attached Hospitals, Jaipur
The 1st Affiliated Hospital of Zhejiang University, Hangzhou
ZheJiang Provincial People's Hospital, Hangzhou
Ningbo First Hospital, Ningbo
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou
The Gujarat Cancer & Research Institute, Ahmedabad
HCG Cancer Centre - Ahmedabad, Ahmedabad
Cancer Care Clinic - Vadodara, Vadodara
Jaslok Hospital and Research Centre, Mumbai
Hunan Cancer Hospital - Oncology Department, Changsha
Jehangir Hospital, Pune
Republican Clinical Oncology Dispensary Kazan, Kazan'
Curie Manavata Cancer Centre, Nashik
Apex Wellness Hospital, Nashik
Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech., Wuhan
Zhongnan hospital ,Wuhan University, Wuhan
Hubei Cancer Hospital, Wuhan
Marathwada Regional Cancer Centre and Research Institute, Aurangabad
Republican Clinical Oncology Dispensary, Ufa
"Ltd EVIMED", Chelyabinsk
Chelyabinsk Regional Oncology Dispensary, Chelyabinsk
Sun Yat-sen University Cancer Center, Guangzhou
Guangzhou First People Hospital, Guangzhou
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center, Shenzhen
Mahatma Gandhi Cancer Hospital & Research Institute, Visakhapatnam
Healthcare Global Enterprises Ltd, Bengaluru
K.L.E.S. Dr. Prabhakar Kore Hospital & Medical Research Centre, Belagavi
Volga District Med Center FMBA, Nizhny Novgorod
Jawaharlal Institute Of Postgraduate Medical Education and R, Gorimedu
SichuanAcademyofMedicalSciences&SichuanProvincialPeople'sHos, Chengdu
Sverdlovsk Regional Clinical Hospital #1, Yekaterinburg
Apollo Speciality Hospitals, Madurai
"Multi-Field Clinical Medical Center Medical City", Tyumen
Meenakshi Mission Hospital & Research Centre, Madurai
LLC Reafan, Novosibirsk
"Medical Center Avicenna", Novosibirsk
Clinical Oncological Dispensary of Omsk Region, Omsk
Regional Cancer Centre - Thiruvananthapuram, Thiruvananthapuram
Tata Medical Center, Kolkata
The First Affiliated Hospital of Xi'an Jiaotong University, Xi’an
Sparsh Hospital & Critical Care, Bhubaneswar
All India Institute of Medical Sciences, Bhubaneswar
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City
OncoCentro, Viña del Mar
Centro de Investigación Clínica del Sur, Temuco
Centro de Estudios Clínicos SAGA SpA, Providencia
Fundación Arturo López Perez, Santiago
Oncovida, Santiago
Assistência Multidisciplinar em Oncologia (AMO), Salvador
Hosp. Araujo Jorge da Associação de Combate ao Câncer, Goiânia
Hospital da Universidade Federal de Minas Gerais, Belo Horizonte
Cetus Oncologia Hospital Dia, Belo Horizonte
Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner, Curitiba
"Liga Norte Riograndense Contra o Cancer , Centro de Pesquisa Clínica"
Unidade de Pesquisas Clinicas em Oncologia, Pelotas
"Santa Casa de Porto Alegre , Hospital Sao Francisco - Centro Medico Pesquisa Clinica Cardiologia"
"FZ Pesquisa e Servicos em Cardiologia , Porto Alegre, Brazil"
Hospital Mae de Deus, Porto Alegre
Fundacao Pio XII - Hospital de Cancer de Barretos, Barretos/SP
"Hospital de Base , Funfarme - Centro Integrado de Pesquisa - Cardiologia"
Urobrasil, São Paulo
IBCC - Instituto Brasileiro de Controle do Cancer, São Paulo
Inst. de Assistência Médica ao Sérvidor Público Estadual, São Paulo
Instituto COI de Educação e Pesquisa, Rio de Janeiro
G. Kenneth Jansz Medicine Professional Corporation, Burlington
Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM), Montreal
Hospital Clínico de la Pontificia Univ. Católica de Chile, Santiago
UROMED, Santiago
Sichuan University West China Hospital, Chengdu
Amrita Institute of Medical Sciences, Kochi
Rajiv Gandhi Cancer Institute & Research Centre, New Delhi
Daugavpils Regional Hospital, Daugavpils
URO Ltd., Riga
P. Stradins Clinical University Hospital, Riga
Vidzemes Hospital, Valmiera
The Hospital of Lithuanian University of Health SciencesLUHS, Kaunas
PI Klaipedos University Hospital, Klaipėda
National Cancer Institute, Vilnius
Vilnius University Hospital Santaros Klinikos, Vilnius
Hospital Militar Luis Arias Schreiber, Lima
Clínica El Golf, Lima
Parc Tauli Hospital Universitari - Oncologia, Sabadell
Kyiv City Hospital #3 - Department of Urology, Kyiv
Lead Sponsor
Orion Corporation, Orion Pharma
INDUSTRY
Bayer
INDUSTRY