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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

669

Participants

Timeline

Start Date

February 23, 2021

Primary Completion Date

June 7, 2024

Study Completion Date

January 30, 2026

Conditions
Prostatic Neoplasms
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

Trial Locations (131)

2

University of Pretoria, Clinical Research Unit, Pretoria

704

National Cheng Kung University Hospital, Tainan City

1038

RAKUS Hospital Gailezers, Riga

1475

East Rand Medical Research Unit, Johannesburg

2065

Northern Cancer Institute, St Leonards

2109

Macquarie University Hospital - Oncology Department, Sydney

2747

Nepean Hospital, Kingswood

3084

Austin Health, Heidelberg

3112

Tauranga Urology Research Limited, Tauranga

3199

Peninsula Oncology Centre, Frankston

3240

Waikato Hospital, Hamilton

4107

Kyiv Regional Oncological Dispensary, Kyiv

5000

Cancer Research South Australia, Adelaide

6045

Cancercare Langenhoven, Port Elizabeth

7570

Cape Town Oncology Trials, Cape Town

8013

Canterbury Urology Research Trust, Christchurch

8025

Fundacio Puigvert - Urologia, Barcelona

10003

Hospital San Pedro de Alcántara - Oncologia, Cáceres

11217

Taipei Veterans General Hospital, Taipei

15033

Hospital Guillermo Almenara Irigoyen, Santiago de Surco

15036

Aliada, San Isidro

18009

"CNE Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of the Cherkasy Regional Council", Cherkasy

20910

Hospital Universitario Virgen De La Victoria - Urologia, Málaga

28922

Hospital Universitario Fundacion Alcorcon - Urologia, Alcorcón

40705

Taichung Veterans General Hospital, Taichung

41013

Hospital Universitario Virgen Del Rocio S.L. - Urologia, Seville

49102

City Dnipropetrovsk Multi- field Clinical Hosp. 4 DSMA, Dnipro

50006

Changhua Christian Hospital, Changhua

100000

Cancer Hospital, Chinese Academy of Medical Sciences, Beijing

100083

Peking University Third Hospital, Beijing

100142

Beijing Cancer Hospital, Beijing

100730

Beijing Hospital, Beijing

110042

Liaoning Cancer Hospital and Institute, Shengyang

117997

Research Centre of X-ray and Radiology, Moscow

130021

1st Hospital of Jilin University, Changchun

141008

Christian Medical Center & Hospital, Ludhiana

153040

Ivanovo Regional Oncology Dispensary, Ivanovo

160012

Post Graduate Institute of Medical Education and Research, Chandigarh

160022

Vologda Regional Hospital, Vologda

163045

Arkhangelsk Clinical Oncology Dispensary, Arkhangelsk

196006

AV Medical Group, Saint Petersburg

197758

Russian Scientific Radiology and Surgery Technologies Center, Saint Petersburg

Scientific Research Instutute of Oncology n.a. N.N. Petrov, Saint Petersburg

210008

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

215004

The 2nd Affiliated Hospital of Soochow University, Suzhou

226361

Nantong tumor hospital, Nantong

230031

Anhui Provincial Hospital, Hefei City, Anhui Province

264000

Yantai Yuhuangding Hospital, Yantai

302017

Sawami Man Singh (SMS) Medical College & Attached Hospitals, Jaipur

310000

The 1st Affiliated Hospital of Zhejiang University, Hangzhou

310014

ZheJiang Provincial People's Hospital, Hangzhou

315010

Ningbo First Hospital, Ningbo

325000

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou

380016

The Gujarat Cancer & Research Institute, Ahmedabad

380060

HCG Cancer Centre - Ahmedabad, Ahmedabad

390007

Cancer Care Clinic - Vadodara, Vadodara

400026

Jaslok Hospital and Research Centre, Mumbai

410013

Hunan Cancer Hospital - Oncology Department, Changsha

411001

Jehangir Hospital, Pune

420029

Republican Clinical Oncology Dispensary Kazan, Kazan'

422004

Curie Manavata Cancer Centre, Nashik

422009

Apex Wellness Hospital, Nashik

430030

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

430071

Zhongnan hospital ,Wuhan University, Wuhan

430079

Hubei Cancer Hospital, Wuhan

431001

Marathwada Regional Cancer Centre and Research Institute, Aurangabad

450054

Republican Clinical Oncology Dispensary, Ufa

454048

"Ltd EVIMED", Chelyabinsk

454087

Chelyabinsk Regional Oncology Dispensary, Chelyabinsk

510000

Sun Yat-sen University Cancer Center, Guangzhou

510180

Guangzhou First People Hospital, Guangzhou

518172

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center, Shenzhen

530017

Mahatma Gandhi Cancer Hospital & Research Institute, Visakhapatnam

560027

Healthcare Global Enterprises Ltd, Bengaluru

590010

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

603109

Volga District Med Center FMBA, Nizhny Novgorod

605006

Jawaharlal Institute Of Postgraduate Medical Education and R, Gorimedu

610072

SichuanAcademyofMedicalSciences&SichuanProvincialPeople'sHos, Chengdu

620102

Sverdlovsk Regional Clinical Hospital #1, Yekaterinburg

625020

Apollo Speciality Hospitals, Madurai

625041

"Multi-Field Clinical Medical Center Medical City", Tyumen

625107

Meenakshi Mission Hospital & Research Centre, Madurai

630099

LLC Reafan, Novosibirsk

"Medical Center Avicenna", Novosibirsk

644013

Clinical Oncological Dispensary of Omsk Region, Omsk

695011

Regional Cancer Centre - Thiruvananthapuram, Thiruvananthapuram

700156

Tata Medical Center, Kolkata

710061

The First Affiliated Hospital of Xi'an Jiaotong University, Xi’an

751007

Sparsh Hospital & Critical Care, Bhubaneswar

751019

All India Institute of Medical Sciences, Bhubaneswar

807377

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

2520598

OncoCentro, Viña del Mar

4781156

Centro de Investigación Clínica del Sur, Temuco

7500653

Centro de Estudios Clínicos SAGA SpA, Providencia

7500921

Fundación Arturo López Perez, Santiago

7510032

Oncovida, Santiago

41950-640

Assistência Multidisciplinar em Oncologia (AMO), Salvador

74605-070

Hosp. Araujo Jorge da Associação de Combate ao Câncer, Goiânia

30130-100

Hospital da Universidade Federal de Minas Gerais, Belo Horizonte

30150-270

Cetus Oncologia Hospital Dia, Belo Horizonte

81520-060

Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner, Curitiba

Rio Grande do Norte

"Liga Norte Riograndense Contra o Cancer , Centro de Pesquisa Clínica"

96020-080

Unidade de Pesquisas Clinicas em Oncologia, Pelotas

Rio Grande do Sul

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

"FZ Pesquisa e Servicos em Cardiologia , Porto Alegre, Brazil"

90850-170

Hospital Mae de Deus, Porto Alegre

14784-400

Fundacao Pio XII - Hospital de Cancer de Barretos, Barretos/SP

São Paulo

"Hospital de Base , Funfarme - Centro Integrado de Pesquisa - Cardiologia"

01243-020

Urobrasil, São Paulo

03102-002

IBCC - Instituto Brasileiro de Controle do Cancer, São Paulo

04039-004

Inst. de Assistência Médica ao Sérvidor Público Estadual, São Paulo

22793-080

Instituto COI de Educação e Pesquisa, Rio de Janeiro

L7N 3V2

G. Kenneth Jansz Medicine Professional Corporation, Burlington

H2X 0A9

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

TBC

Hospital Clínico de la Pontificia Univ. Católica de Chile, Santiago

Unknown

UROMED, Santiago

MISSING

Sichuan University West China Hospital, Chengdu

682 041

Amrita Institute of Medical Sciences, Kochi

110 085

Rajiv Gandhi Cancer Institute & Research Centre, New Delhi

LV-5417

Daugavpils Regional Hospital, Daugavpils

LV-1001

URO Ltd., Riga

LV-1002

P. Stradins Clinical University Hospital, Riga

LV-4201

Vidzemes Hospital, Valmiera

LT-50009

The Hospital of Lithuanian University of Health SciencesLUHS, Kaunas

LT-92288

PI Klaipedos University Hospital, Klaipėda

LT-08660

National Cancer Institute, Vilnius

LT-08661

Vilnius University Hospital Santaros Klinikos, Vilnius

LIMA 11

Hospital Militar Luis Arias Schreiber, Lima

LIMA 27

Clínica El Golf, Lima

08208

Parc Tauli Hospital Universitari - Oncologia, Sabadell

02660

Kyiv City Hospital #3 - Department of Urology, Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Orion Corporation, Orion Pharma

INDUSTRY

lead

Bayer

INDUSTRY