Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer

April 13, 2026 updated by: Bayer

An Open-label, Single Arm, Roll-over Study to Provide Continued Treatment With Darolutamide in Participants Who Were Enrolled in Previous Bayer Sponsored Studies

The aim of this study is to provide darolutamide treatment to patients who participated in a previous study with darolutamide supported by Bayer and the treating doctor considers that the continuation of the treatment with darolutamide to be beneficial. Patients will be carried over from the previous studies and continue in this study with darolutamide treatment on the same dosage. They will also return to the study centers for doctor's visits as often as they did in the previous study.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

402

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Ciudad Auton. de Buenos Aires
      • Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1120AAT
        • Centro de Urología
  • Australia
    • South Australia
      • Kurralta Park, South Australia, Australia, 5037
        • Adelaide Cancer Centre Research Pty Ltd
  • Austria
    • State of Vienna
      • Vienna, State of Vienna, Austria, 1090
        • Universitätsklinikum AKH Wien
  • Belarus
    • Minsk Oblast
      • Lyasny, Minsk Oblast, Belarus, 223040
        • N.N. Alexandrov National Cancer Centre of Belarus - Oncology Department
      • Minsk, Minsk Oblast, Belarus, 220013
        • Minsk City Clinical Oncological Dispensary - Oncology Department
  • Belgium
      • Kortrijk, Belgium, 8500
        • AZ Groeninge Campus Kennedylaan
      • Liège, Belgium, 4000
        • CHU de Liege
    • Antwerpen
      • Wilrijk, Antwerpen, Belgium, 2610
        • GZA Ziekenhuizen
  • Brazil
    • Ceará
      • Fortaleza, Ceará, Brazil, 60430-230
        • Instituto do Cancer do Ceara
    • Espírito Santo
      • Cachoeiro de Itapemirim, Espírito Santo, Brazil, 29308-020
        • Hospital Evangelico de Cachoeiro de Itapemirim
    • Goiás
      • Goiânia, Goiás, Brazil, 74605-070
        • Hosp. Araujo Jorge da Associação de Combate ao Câncer
      • Goiânia, Goiás, Brazil, 88301-220
        • Clinica de Neoplasias Litoral Ltda
    • Minas Gerais
      • Uberlândia, Minas Gerais, Brazil, 38408-150
        • COT Centro Oncologico do Triangulo Ltda
    • Paraná
      • Curitiba, Paraná, Brazil, 81520-060
        • Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59040-000
        • Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica
    • Rio Grande do Sul
      • Passo Fundo, Rio Grande do Sul, Brazil, 99010-080
        • Associação Hospitalar Beneficente São Vicente de Paulo
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784-400
        • Fundação Pio XII - Hospital de Câncer de Barretos
      • Jaú, São Paulo, Brazil, 17210-120
        • Hospital Amaral Carvalho
      • Jaú, São Paulo, Brazil, 03102-002
        • IBCC - Instituto Brasileiro de Controle do Cancer
      • Ribeirão Preto, São Paulo, Brazil, 14051-140
        • Hosp Clínicas Facult. Med. de Ribeirão Preto / USP
      • São Paulo, São Paulo, Brazil, 01246-000
        • Instituto do Cancer do Estado de Sao Paulo
      • São Paulo, São Paulo, Brazil, 41253-190
        • Hospital Sao Rafael
      • São Paulo, São Paulo, Brazil, 50040-410
        • Santa Casa de Misericórdia da Bahia
      • São Paulo, São Paulo, Brazil, 90020-090
        • Irmandade Santa Casa de Misericordia de Porto Alegre | Oncology
      • São Paulo, São Paulo, Brazil, 90619-900
        • União Bras. de Edu. e Assist. Hospital São Lucas da PUCRS
  • Bulgaria
    • Sofia City Province
      • Sofia, Sofia City Province, Bulgaria, 1680
        • Medical Center Kalimat
    • Vratsa Province
      • Vratsa, Vratsa Province, Bulgaria, 3000
        • Complex Oncology Center - Vratsa
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2V 1P9
        • Prostate Cancer Centre
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Nova Scotia Health Authority
    • Ontario
      • Burlington, Ontario, Canada, L7N 3V2
        • G. Kenneth Jansz Medicine Professional Corporation
      • London, Ontario, Canada, N5R 6M6
        • London Health Sciences Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital-University Health Network
    • Quebec
      • Granby, Quebec, Canada, J2G 1T7
        • Centre hospitalier universitaire de Sherbrooke (CHUS) | Oncology
      • Montreal, Quebec, Canada, H2X 0C1
        • Centre Hospitalier de l'Universite de Montreal (CHUM) | Oncology
  • China
      • Beijing, China, 100083
        • Peking University Third Hospital
      • Beijing, China, 100000
        • Cancer Hospital, Chinese Academy of Medical Sciences
      • Chengdu, China, 610072
        • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital (SAMSPH)
      • Chongqing, China, 400030
        • Chongqing Cancer Hospital
      • Guangzhou, China, 510000
        • Sun Yat-sen University Cancer Center
      • Ningbo, China, 315010
        • Ningbo First Hospital
      • Shandong, China, 266000
        • The Affiliated Hospital Of Qingdao University
      • Shanghai, China, 200032
        • Zhongshan Hospital, Fudan University
      • Shanghai, China, 200080
        • Shanghai General Hospital
      • Shanghai, China, 200040
        • Huadong Hospital, Affiliated to Fudan University
      • Shanghai, China, 200000
        • Fudan University Shanghai Cancer Center - Oncology Department
      • Shanghai, China, 200025
        • Ruijin Hosp. Shanghai Jiaotong Univ.School of Medicine
      • Shenzhen, China, 518172
        • Cancer Hospital Chinese Academy of Medical Sciences, ShenZhen center
      • Tianjin, China, 300211
        • The Second Hospital of Tianjin Medical University
      • Tianjin, China, 300000
        • Tianjin Medical University Cancer Institute & Hospital
      • Zhejiang, China, 314408
        • Zhejiang Provincial People's Hospital
    • Anhui
      • Hefei, Anhui, China, 230601
        • The Second Affiliated Hospital of Anhui Medical University
      • Hefei City, Anhui Province, Anhui, China, 230031
        • Anhui Provincial Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Beijing Hospital
      • Beijing, Beijing Municipality, China, 100142
        • Beijing Cancer Hospital - Oncology Department
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • The First Affiliated Hospital of Fujian Medical University
      • Xiamen, Fujian, China, 361003
        • The First Affiliated Hospital of Xiamen University
    • Guangdong
      • Shantou, Guangdong, China, 515021
        • 2nd Affiliated Hosp. of Shantou University Medical College
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.
      • Wuhan, Hubei, China, 430079
        • Hubei Cancer Hospital
    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital - Oncology Department
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • the First Affiliated Hospital of Nanjing Medical University
      • Nanjing, Jiangsu, China, 210008
        • NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
      • Nanjing, Jiangsu, China, 210000
        • Jiangsu Cancer Hospital
      • Nantong, Jiangsu, China, 226361
        • Nantong Tumor Hospital
      • Suzhou, Jiangsu, China, 215004
        • The 2nd Affiliated Hospital of Soochow University
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University
    • Jilin
      • Changchun, Jilin, China, 130061
        • The First Hospital of Jilin University
    • Liaoning
      • Shengyang, Liaoning, China, 110042
        • Liaoning Cancer Hospital and Institute
    • Shandong
      • Jinan, Shandong, China, 250012
        • Qilu Hosp., Shandong Univ.
      • Yantai, Shandong, China, 264000
        • Yantai Yuhuangding Hospital
    • Shanxi
      • Taiyuan, Shanxi, China, TBC
        • Shanxi Medical University - First Hospital
      • Xi’an, Shanxi, China, 710061
        • The First Affiliated Hospital of Xi'an Jiaotong University
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Sichuan University West China Hospital
      • Chengdu, Sichuan, China, 610041
        • University of Electronic Science & Technology of China - Sichuan Cancer Hospital & Institute (Sichuan Provincial Tumor Hospital)
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Zhejiang Provincial People's Hospital
      • Wenzhou, Zhejiang, China, 325000
        • The First Affiliated Hospital of Wenzhou Medical University
  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 050034
        • Hospital Pablo Tobón Uribe
    • Departamento de Córdoba
      • Montería, Departamento de Córdoba, Colombia, 230002
        • Oncomedica S.A.
    • Santander Department
      • Floridablanca, Santander Department, Colombia, 681004
        • Fundación Oftalmológica de Santander Carlos Ardila Lule
  • Czechia
      • Brno, Czechia, 65653
        • Masarykuv Onkologicky Ustav
      • Jablonec nad Nisou, Czechia, 46601
        • Nemocnice Jablonec nad Nisou
      • Prague, Czechia, 12808
        • Vseobecna fakultni nemocnice v Praze
      • Prague, Czechia, 10034
        • Fakultni nemocnice Kralovske Vinohrady
      • Prague, Czechia, 120 00
        • Urocentrum Praha, s.r.o.
      • Prague, Czechia, 160 00
        • Androgeos, spol. s r.o.
  • Estonia
    • Harju
      • Tallinn, Harju, Estonia, 13419
        • Sihtasutus Põhja-Eesti Regionaalhaigla - Onkoloogia- ja hematoloogiakliinik
  • Finland
    • Central Finland
      • Jyväskylä, Central Finland, Finland, 40620
        • Keski-Suomen sairaala Nova
    • North Ostrobothnia
      • Oulu, North Ostrobothnia, Finland, 90220
        • Oulu University Hospital, Oulun yliopistollinen sairaala (OYS)
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • Tampere University Hospital, Tampereen yliopistollinen sairaala (TAYS)
    • South Ostrobothnia
      • Seinäjoki, South Ostrobothnia, Finland, 60220
        • Seinäjoen keskussairaala
    • South Savo
      • Mikkeli, South Savo, Finland, 50100
        • Mikkelin keskussairaala
    • Southwest Finland
      • Turku, Southwest Finland, Finland, 20520
        • Turun yliopistollinen keskussairaala
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00029
        • HUS, Meilahden sairaala
  • France
    • Auvergne-Rhône-Alpes
      • Clermont-Ferrand, Auvergne-Rhône-Alpes, France, 63011
        • Centre Jean Perrin
      • Pierre-Bénite, Auvergne-Rhône-Alpes, France, 69495
        • HCL - Centre Hospitalier Lyon Sud
    • Bourgogne-Franche-Comté
      • Dijon, Bourgogne-Franche-Comté, France, 21000
        • Centre d'Oncologie et de Radiologie du Parc
    • Brittany Region
      • Brest, Brittany Region, France, 29200
        • Clinique Lanroze
      • Rennes, Brittany Region, France, 35033
        • CHU Rennes - Hopital Pontchaillou
    • Centre-Val de Loire
      • Tours, Centre-Val de Loire, France, 37044
        • Chu Tours - Hopital Bretonneau
    • Grand Est
      • Reims, Grand Est, France, 51056
        • Institut de Cancerologie Jean Godinot - Departement oncologie medicale
    • Normandy
      • Rouen, Normandy, France, 76031
        • Hôpital Charles Nicolle
    • Nouvelle-Aquitaine
      • Bordeaux, Nouvelle-Aquitaine, France, 33000
        • Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale
      • Poitiers, Nouvelle-Aquitaine, France, 86021
        • Hopital de la Milétrie
    • Occitanie
      • Montpellier, Occitanie, France, 34298
        • ICM - Institut du Cancer de Montpellier - Val d'Aurelle
    • Pays de la Loire Region
      • Angers, Pays de la Loire Region, France, 49933
        • Centre Hospitalier Universitaire - Angers
      • Nantes, Pays de la Loire Region, France, 44000
        • Hopital Hotel Dieu - Nantes
      • Saint-Herblain, Pays de la Loire Region, France, 44800
        • Institut de Cancerologie Ouest - Saint-Herblain
    • Provence-Alpes-Côte d'Azur Region
      • Marseille, Provence-Alpes-Côte d'Azur Region, France, 13273
        • Institut Paoli-Calmettes - Marseille
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75010
        • Hopital Saint Louis
      • Saint-Mandé, Île-de-France Region, France, 94160
        • Hôpital d'Instruction des Armées BEGIN
      • Suresnes, Île-de-France Region, France, 92151
        • Centre Médico-Chirurgical Foch
      • Villejuif, Île-de-France Region, France, 94805
        • Gustave Roussy - Departement Oncologie-Radiotherapie
  • Germany
    • Baden-Wurttemberg
      • Emmendingen, Baden-Wurttemberg, Germany, 79312
        • Urologische Gemeinschaftspraxis Carl-Andreas-Meilinger
      • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
        • Universitätsklinikum Freiburg
      • Mühlacker, Baden-Wurttemberg, Germany, 75417
        • Urologische Gemeinschaftspraxis Muehlacker
      • Nürtingen, Baden-Wurttemberg, Germany, 72622
        • Studienpraxis Urologie
      • Reutlingen, Baden-Wurttemberg, Germany, 72764
        • Urologische Gemeinschaftspraxis Dr. Simone Maier
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Uniklinik Tübingen / Urologie
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Universitätsklinikum Erlangen
    • Lower Saxony
      • Braunschweig, Lower Saxony, Germany, 38126
        • Städtisches Klinikum Braunschweig GmbH
    • North Rhine-Westphalia
      • Düsseldorf, North Rhine-Westphalia, Germany, 40225
        • Universitatsklinikum Dusseldorf
      • Mülheim, North Rhine-Westphalia, Germany, 45468
        • Praxis Drs. Tim Schneider /B. Schneider
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Universitätsklinikum Münster
      • Wuppertal, North Rhine-Westphalia, Germany, 42103
        • Uro-Gyn-Zentrum Wall Hr. Dr. Jochen Gleißner
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55101
        • Universitätsmedizin der Johannes Gutenberg Universität Mainz
    • Saxony-Anhalt
      • Magdeburg, Saxony-Anhalt, Germany, 39120
        • Medizinische Fakultät der Otto-von-Guericke Universität
    • Thuringia
      • Jena, Thuringia, Germany, 7747
        • Friedrich-Schiller-Uni. Jena
  • Hungary
      • Szekszárd, Hungary, 7100
        • Tolna Varmegyei Balassa Janos Korhaz
      • Zalaegerszeg, Hungary, 8900
        • Zala Varmegyei Szent Rafael Korhaz
  • Israel
      • Beersheba, Israel, 8410101
        • Clalit Health | Soroka Medical Center - Internal Medicine Department
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center | Beilinson Hospital - Internal Medicine C Department
      • Safed, Israel, 1311001
        • Health Corporation of the Ziv Medical Center (R.A.)
  • Italy
    • Campania
      • Naples, Campania, Italy, 80131
        • IRCCS Istituto Nazionale Tumori Fondazione Pascale
    • Emilia-Romagna
      • Parma, Emilia-Romagna, Italy, 43126
        • Azienda Ospedaliero Universitaria Parma
    • Piedmont
      • Orbassano, Piedmont, Italy, 10043
        • Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Oncologia Medica
      • Turin, Piedmont, Italy, 10060
        • Istituto di Candiolo Fondazione del Piemonte per l'oncologia IRCCS
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Istituto Oncologico Veneto_Padova - UOC Oncologia 1
  • Japan
      • Chiba, Japan, 260-8717
        • Chiba Cancer Center
      • Gifu, Japan, 500-8717
        • Gifu Prefectural General Medical Center
      • Hiroshima, Japan, 730-8518
        • Hiroshima City Hiroshima Citizens Hospital
      • Kumamoto, Japan, 860-0008
        • National Hospital Organization Kumamoto Medical Center
      • Miyazaki, Japan, 889-1692
        • University of Miyazaki Hospital
      • Nagasaki, Japan, 852-8501
        • Nagasaki University Hospital
      • Osaka, Japan, 558-8558
        • Osaka General Medical Center
      • Toyama, Japan, 930-0194
        • Toyama University Hospital
      • Wakayama, Japan, 640-8558
        • Wakayama Medical University Hospital
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 466-8560
        • Nagoya University Hospital
    • Chiba
      • Asahi, Chiba, Japan, 289-2511
        • Asahi General Hospital
      • Sakura, Chiba, Japan, 285-8741
        • Toho University Sakura Medical Center
    • Gunma
      • Maebashi, Gunma, Japan, 371-8511
        • Gunma University Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8543
        • Sapporo Medical University Hospital
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0017
        • Kobe University Hospital
    • Ibaraki
      • Higashiibaraki, Ibaraki, Japan, 311-3193
        • National Hospital Organization Mito Medical Center
    • Kanagawa
      • Sagamihara, Kanagawa, Japan, 252-0375
        • Kitasato University Hospital
      • Yokohama, Kanagawa, Japan, 232-0024
        • Yokohama City University Medical Center
      • Yokosuka, Kanagawa, Japan, 238-8558
        • Yokosuka Kyosai Hospital
    • Mie-ken
      • Tsu, Mie-ken, Japan, 514-8507
        • Mie University Hospital
    • Nagano
      • Ueda, Nagano, Japan, 386-8610
        • National Hospital Organization Shinshu Ueda Medical Center
    • Oita Prefecture
      • Yufu, Oita Prefecture, Japan, 879-5593
        • Oita University Hospital
    • Osaka
      • Osaka, Osaka, Japan, 541-8567
        • Osaka International Cancer Institute
      • Sakai, Osaka, Japan, 590-0197
        • Kindai University Hospital
      • Suita, Osaka, Japan, 565-0871
        • The University of Osaka Hospital
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3192
        • Hamamatsu University Hospital
    • Tochigi
      • Utsunomiya, Tochigi, Japan, 321-0974
        • Saiseikai Utsunomiya Hospital
    • Tokyo
      • Bunkyo-Ku, Tokyo, Japan, 113-0022
        • Nippon Medical School Hospital
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Juntendo University Hospital
      • Itabashi-ku, Tokyo, Japan, 173-0015
        • Tokyo Metropolitan Institute for Geriatrics and Gerontology
      • Mitaka, Tokyo, Japan, 181-8611
        • Kyorin University Hospital
      • Nakano-ku, Tokyo, Japan, 164-8541
        • Tokyo Metropolitan Police Hospital
      • Shinjuku-ku, Tokyo, Japan, 160-8582
        • Keio University Hospital
      • Sumida-ku, Tokyo, Japan, 130-8587
        • The Fraternity Memorial Hospital
    • Tottori
      • Yonago, Tottori, Japan, 683-8504
        • Tottori University Hospital
    • Yamaguchi
      • Ube, Yamaguchi, Japan, 755-8505
        • Yamaguchi University Hospital
  • Latvia
    • Daugavpils City
      • Daugavpils, Daugavpils City, Latvia, LV-5417
        • Daugavpils Regional Hospital
    • Liepaja City
      • Liepāja, Liepaja City, Latvia, LV-3401
        • Litavniece Dzintra practice in urology and oncological chem.
    • Riga City
      • Riga, Riga City, Latvia, LV-1002
        • P. Stradins Clinical University hospital
      • Riga, Riga City, Latvia, LV-1029
        • AS "Association of Health Centers" polyclinic "Elite"
      • Riga, Riga City, Latvia, LV-1038
        • Riga East Clinical University Hospital "Gailezers"
    • Valmiera City
      • Valmiera, Valmiera City, Latvia, LV-4201
        • Vidzemes Hospital
  • Lithuania
      • Kaunas, Lithuania, LT-50161
        • Hospital of LT University of Health Sciences Kaunas Clinics
      • Klaipėda, Lithuania, LT-92288
        • PI Klaipedos University Hospital
      • Vilnius, Lithuania, LT-08660
        • National Cancer Institute
      • Vilnius, Lithuania, LT-08661
        • Vilnius University Hospital Santaros Klinikos
  • Mexico
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Hospital Universitario "José Eleuterio González"
    • Querétaro
      • Querétaro City, Querétaro, Mexico, 76000
        • INBIOMEDyC Querétaro
  • Netherlands
    • Limburg
      • Geleen, Limburg, Netherlands, 6162 BG
        • Zuyderland Medical Centre | Internal Medicine Department
    • North Brabant
      • Tilburg, North Brabant, Netherlands, 5042 AD
        • ETZ TweeSteden Ziekenhuis (vh Maria Ziekenhuis)
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1105 AZ
        • Academisch Medisch Centrum (AMC)
      • Hilversum, North Holland, Netherlands, 1213 VG
        • Tergooi MC | Hilversum - Wetenschapsbureau
      • Hoofddorp, North Holland, Netherlands, 2134 TM
        • Spaarne Gasthuis
    • South Holland
      • Dordrecht, South Holland, Netherlands, 3318 AT
        • Albert Schweitzer Ziekenhuis | Dordwijk - Cardiology Department
      • The Hague, South Holland, Netherlands, 2545 CH
        • HagaZiekenhuis
  • Peru
    • Lima Province (Provincia de Lima)
      • La Victoria, Lima Province (Provincia de Lima), Peru, 15036
        • Centro Médico Monte Carmelo - Oncology Department
      • Lima, Lima Province (Provincia de Lima), Peru, 15036
        • Instituto Peruano de Oncología & Radioterapia - Oncologia SA - Oncology Department
      • Lima, Lima Province (Provincia de Lima), Peru, 15046
        • Hospital Central de la Fuerza Aerea del Peru
  • Poland
      • Lodz, Poland, 90-302
        • ETG Network Spolka z o.o.
      • Lublin, Poland, 20-362
        • KO-MED Centra Kliniczne Lublin II
      • Otwock, Poland, 05-400
        • Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina
      • Siedlce, Poland, 08-110
        • Urologica Praktyka Lekarska Adam Marcheluk
      • Warsaw, Poland, 04-073
        • Szpital Grochowski im. dr.med. Rafala Masztaka
  • Portugal
      • Lisbon, Portugal, 1099-023
        • Ipo Lisboa
      • Lisbon, Portugal, 1500-650
        • Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica
      • Lisbon, Portugal, 1150-199
        • CHLC - Hospital Sao Jose
      • Porto, Portugal, 4200-072
        • IPO Porto
      • Porto, Portugal, 4200-319
        • Unidade Local de Saúde de São João E.P.E. - Hospital São João - Serviço de Urologia
    • Setúbal District
      • Almada, Setúbal District, Portugal, 2805-267
        • Unidade Local de Saude Almada-Seixal | Hospital Garcia de Orta - Research Department
  • Romania
      • Bucharest, Romania, 22328
        • Institutul Clinic Fundeni, sectia Nefrologie Clinica
    • Mure?
      • Târgu Mureş, Mure?, Romania, 540103
        • Spitalul Clinic Judetean Mures
  • Russia
      • Chelyabinsk, Russia, 454087
        • Chelyabinsk Regional Oncology Dispensary
      • Chelyabinsk, Russia, 454048
        • Ltd "EVIMED"
      • Ivanovo, Russia, 153040
        • Ivanovo regional oncology dispensary
      • Kazan', Russia, 420029
        • Republican Clinical Oncology Dispensary Kazan
      • Krasnoyarsk, Russia, 660133
        • Krasnoyarsk Regional Clinical Oncology Dispensary
      • Moscow, Russia, 115478
        • Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS
      • Moscow, Russia, 125284
        • Moscow Scient. Res. Institute of Oncology n.a P.A. Hertzen
      • Nizhny Novgorod, Russia, 603001
        • City Outpatient Clinic #1 of Privolzhsky Regional Med. Cent.
      • Novosibirsk, Russia, 630099
        • LLC Reafan
      • Novosibirsk, Russia, 630099
        • Medical Center "Avicenna"
      • Obninsk, Russia, 249036
        • National Medical Research Radiology Center
      • Omsk, Russia, 644013
        • Clinical Oncological Dispensary of Omsk Region
      • Saint Petersburg, Russia, 188663
        • Leningrad Regional Oncology Dispensary
      • Saratov, Russia, 410054
        • Saratov State Medical University
      • Tyumen, Russia, 625041
        • Multi-Field Clinical Medical Center "Medical City"
      • Vladimir, Russia, 600009
        • Regional Clinical Oncology Dispensary
  • Serbia
      • Belgrade, Serbia, 11080
        • Clinical Hospital Center Bezanijska Kosa
      • Niš, Serbia, 18000
        • Clinical Center Nis
  • Slovakia
      • Bratislava, Slovakia, 851 01
        • J. BREZA MEDICAL s. r. o.
      • Bratislava, Slovakia, 85101
        • CUIMED s.r.o
  • South Africa
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6045
        • Langehoven Drive Oncology Centre
    • Gauteng
      • Pretoria, Gauteng, South Africa, 2
        • University of Pretoria, Clinical Research Unit
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7570
        • Cape Gate Oncology Centre
      • Cape Town, Western Cape, South Africa, 7505
        • Dept Radiation and Oncology Tygerberg Academic Hospital
      • George, Western Cape, South Africa, 6529
        • Cancercare Outeniqua
      • Rondebosch, Western Cape, South Africa, 7700
        • Cancercare Rondebosch Oncology
  • South Korea
      • Daegu, South Korea, 42601
        • Keimyung University Dongsan Medical Center
      • Daegu, South Korea, 700721
        • Kyungpook National University Chilgok Hospital
      • Incheon, South Korea, 21565
        • Gachon University Gil Medical Center-Department of Urology
      • Seoul, South Korea, 06351
        • Samsung Medical Center - Oncology Department
      • Seoul, South Korea, 137-701
        • The Catholic University of Korea Seoul St. Mary'S Hospital
    • Gwangju Gwang''yeogsi
      • Gwangju, Gwangju Gwang''yeogsi, South Korea, 501-757
        • Chonnam National University Hospital | Urology
    • North Chungcheong
      • Chungcheongbuk-do, North Chungcheong, South Korea, 28644
        • Chungbuk National University Hospital-Department of Urology
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Seoul Teugbyeolsi, South Korea, 03080
        • Seoul National University Hospital-Department of Urology
      • Seoul, Seoul Teugbyeolsi, South Korea, 05505
        • Asan Medical Center | Urology
      • Seoul, Seoul Teugbyeolsi, South Korea, 06273
        • Gangnam Severance Hospital, Yonsei University Health System-Department of Urology
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall D Hebron | Oncologia
      • Barcelona, Spain, 8041
        • Hospital De La Santa Creu I Sant Pau | Oncologia
      • Barcelona, Spain, 8036
        • Hospital Clinic De Barcelona | Urologia
      • Barcelona, Spain, 08003
        • Hospital del Mar I Oncologia
      • Barcelona, Spain, 8908
        • Bellvitge Hospital Universitari | Urologia
      • Cáceres, Spain, 10003
        • Hospital San Pedro De Alcantara | Oncologia
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia | Oncologia
      • Lugo, Spain, 27003
        • Hospital Universitario Lucus Augusti | Urologia
      • Madrid, Spain, 28009
        • Hospital General Universitario Gregorio Maranon | Urologia
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon Y Cajal | Oncologia
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos | Oncologia
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz | Urologia
      • Madrid, Spain, 28041
        • Hospital Universitario 12 De Octubre | Urologia
      • Málaga, Spain, 29010
        • Hospital Universitario Virgen De La Victoria | Oncologia
      • Seville, Spain, 41013
        • Hospital Universitario Virgen Del Rocio S.L. | Oncologia
      • Valencia, Spain, 46009
        • Fundacion Instituto Valenciano De Oncologia | Urologia
      • Valencia, Spain, 46015
        • Hospital Arnau De Vilanova De Valencia | Oncologia
    • Alicante
      • Elche, Alicante, Spain, 3203
        • Hospital General Universitario De Elche | Urologia
    • Balearic Islands
      • Manacor, Balearic Islands, Spain, 7500
        • Hospital De Manacor | Urologia
      • Palma de Mallorca, Balearic Islands, Spain, 7120
        • Hospital Universitari Son Espases | Oncologia
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Parc Tauli Hospital Universitari | Oncologia
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • Hospital Universitario Fundacion Alcorcon | Urologia
  • Sweden
    • Stockholm County
      • Stockholm, Stockholm County, Sweden, 171 76
        • Karolinska Universitetssjukhuset
    • Uppsala County
      • Uppsala, Uppsala County, Sweden, 752 37
        • Akademiska sjukhuset
    • Västerbotten County
      • Umeå, Västerbotten County, Sweden, 901 85
        • Norrlands Universitetssjukhus, Umea
    • Västra Götaland County
      • Gothenburg, Västra Götaland County, Sweden, 413 45
        • Sahlgrenska Universitetssjukhuset
  • Taiwan
      • Kaohsiung City, Taiwan, 807377
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Taichung, Taiwan, 404327
        • China Medical University Hospital
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taoyuan District, Taiwan, 33305
        • Chang Gung Memorial Hospital at Linkou
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 6560
        • Gazi Universitesi Tip Fakultesi
  • Ukraine
      • Cherkasy, Ukraine, 18009
        • CNE "Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of the Cherkasy Regional Council"
      • Chernivtsi, Ukraine, 58001
        • Regional communal non-profit enterprise 'Chernivtsi regional clinical hospital' - Urological department
      • Dnipro, Ukraine, 49102
        • Municipal Non-commercial Enterprise 'City Clinical Hospital #4' of Dnipro City Council - City ?hemotherapy ?enter
      • Kharkiv, Ukraine, 61037
        • Regional Medical Clinical Center of Urology and Nephrology n.a. V. I. Shapoval - Department of Oncologic Urology #5
      • Kyiv, Ukraine, 02660
        • Kyiv City Hospital #3 - Department of Urology
      • Kyiv, Ukraine, 252053
        • SE "Academician O.F. Vozianov Institute of Urology" of NAMSU - Division of Reconstructive Urology and Advanced Technologies
      • Uzhhorod, Ukraine, 88014
        • Zakarpattia Anti-Tumor Centre - Chemotherapy Department
  • United Kingdom
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG1 5AN
        • Royal Berkshire NHS Foundation Trust¦Royal Berkshire Hospital - Oncology
    • Essex
      • Colchester, Essex, United Kingdom, CO45JR
        • East Suffolk and North Essex NHS Foundation Trust¦Colchester General Hospital - Oncology Trials Unit
    • Greater London
      • London, Greater London, United Kingdom, W6 8RF
        • Charing Cross Hospital
      • London, Greater London, United Kingdom, NW1 2PG
        • University College London Hospitals NHS Foundation Trust
    • Merseyside
      • Bebington, Merseyside, United Kingdom, CH63 4JY
        • Clatterbridge Centre for Oncology
    • North East Lincolnshire
      • Scunthorpe, North East Lincolnshire, United Kingdom, DN15 7BH
        • Scunthorpe General Hospital
    • Scotland
      • Glasgow, Scotland, United Kingdom, G12 0YN
        • NHS Greater Glasgow & Clyde | Beatson West of Scotland Cancer Centre - Clinical Research Unit
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 4XW
        • Cardiff and Vale University Health Board | University Hospital of Wales - Nephrology and Transplant
      • Llanelli, Wales, United Kingdom, SA14 8QF
        • Prince Philip Hospital
    • West Midlands
      • Dudley, West Midlands, United Kingdom, DY1 2HQ
        • Dudley Group NHS Foundation Trust ¦Russells Hall Hopsital - Oncology
    • West Yorkshire
      • Huddersfield, West Yorkshire, United Kingdom, HD3 3EA
        • Calderdale and Huddersfield NHS Foundation Trust¦Huddersfield Royal Infirmary - Oncology
      • Wakefield, West Yorkshire, United Kingdom, WF1 4DG
        • Mid Yorkshire Teaching NHS Trust¦Pinderfields Hospital - Oncology
  • United States
    • Alabama
      • Homewood, Alabama, United States, 35209
        • Urology Centers of Alabama, PC - Homewood
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Ironwood Cancer and Research Centers - Chandler I
    • California
      • Los Angeles, California, United States, 90048
        • Tower Urology
      • Palo Alto, California, United States, 94304
        • Stanford Cancer Center Palo Alto
      • San Diego, California, United States, 92120
        • San Diego Clinical Trials
      • Whittier, California, United States, 90603
        • TOI Clinical Research
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Rocky Mountain Regional VA Medical Center - Oncology
      • Denver, Colorado, United States, 80211
        • The Urology Center of Colorado
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Boca Raton Regional Hospital - Oncology
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Jesse Brown VA Medical Center - Cardiology
      • Peoria, Illinois, United States, 61615
        • Illinois CancerCare - Peoria
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Cancer Institute - Downtown
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Chesapeake Urology Associates - Towson
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital - Pulmonology
      • Salisbury, Maryland, United States, 21801
        • TidalHealth Peninsula Regional, Inc. - Oncology
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital - OB/GYN
    • Montana
      • Billings, Montana, United States, 59102
        • St. Vincent Regional Hospital - Oncology
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • XCancer Omaha
    • New Jersey
      • Voorhees Township, New Jersey, United States, 08043
        • New Jersey Urology - Voorhees
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • New Mexico Cancer Center - Albuquerque
    • New York
      • Rochester, New York, United States, 14642
        • URMC Wilmot Cancer Center
      • The Bronx, New York, United States, 10469
        • New York Cancer & Blood Specialists - Eastchester
      • The Bronx, New York, United States, 14061
        • Montefiore Einstein Center for Cancer Care - Tower at Montefiore Medical Park
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center
      • Cincinnati, Ohio, United States, 45212
        • The Urology Group - Norwood Surgery Center
      • Columbus, Ohio, United States, 43210
        • The Ohio State University - Arthur G James Cancer Hospital and Richard J Solove Research Institute
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • MidLantic Urology - Bala Cynwyd
      • Camp Hill, Pennsylvania, United States, 17011
        • Andrews & Patel Associates
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Charleston Oncology - Downtown
      • Myrtle Beach, South Carolina, United States, 29579
        • Carolina Urological Research Center
    • Tennessee
      • Nashville, Tennessee, United States, 37209
        • Urology Associates, PC - Nashville
    • Texas
      • Dallas, Texas, United States, 75231
        • Urology Clinics of North Texas - Dallas (Walnut HIll Lane)
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute
    • Virginia
      • Richmond, Virginia, United States, 23284
        • VCU Health Ambulatory Care Center - Cardiology
    • Washington
      • Everett, Washington, United States, 98201
        • Providence Regional Cancer Partnership
      • Fairfax, Washington, United States, 22031
        • Inova Schar Cancer Insitute - Inova Fairfax Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  • Participants enrolled in any Bayer-sponsored darolutamide feeder study at the time of study closure or primary completion, who are currently receiving darolutamide and are experiencing clinical benefit from treatment.
  • Participants who have not met any treatment discontinuation criteria in the feeder study protocol.
  • Willingness to continue practicing acceptable methods of birth control during the study.

Exclusion Criteria:

  • Participant is unable to comply with the requirements of the study.
  • Negative benefit/ risk ratio as determined by the investigator.
  • Meet any criteria for treatment discontinuation of the feeder study the participant is coming from.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Darolutamide (BAY1841788)
Participants enrolled in the current study will use the dose they were assigned to in the feeder study they come from.
Drug: Darolutamide (Nubeqa, BAY1841788)
Participants will continue receiving darolutamide treatment at the dose level and schedule of administration previously assigned in the feeder study.
Other Names:
  • ODM-201

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: Up to 4 years
Up to 4 years
Incidence of treatment-emergent serious adverse events (TESAEs)
Time Frame: Up to 4 years
Up to 4 years
Incidence of drug-related TEAEs
Time Frame: Up to 4 years
Up to 4 years
Incidence of drug-related TESAEs
Time Frame: Up to 4 years
Up to 4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of dose modifications
Time Frame: Up to 4 years
Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2020

Primary Completion (Estimated)

June 26, 2028

Study Completion (Estimated)

June 26, 2028

Study Registration Dates

First Submitted

July 7, 2020

First Submitted That Met QC Criteria

July 7, 2020

First Posted (Actual)

July 9, 2020

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20321
  • 2019-003618-15 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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