Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported 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
2 other identifiers
interventional
402
35 countries
328
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 cancer
Started Oct 2020
Longer than P75 for phase_3 cancer
328 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2020
CompletedFirst Posted
Study publicly available on registry
July 9, 2020
CompletedStudy Start
First participant enrolled
October 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 26, 2028
April 15, 2026
April 1, 2026
7.7 years
July 7, 2020
April 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Incidence of treatment-emergent adverse events (TEAEs)
Up to 4 years
Incidence of treatment-emergent serious adverse events (TESAEs)
Up to 4 years
Incidence of drug-related TEAEs
Up to 4 years
Incidence of drug-related TESAEs
Up to 4 years
Secondary Outcomes (1)
Number of dose modifications
Up to 4 years
Study Arms (1)
Darolutamide (BAY1841788)
EXPERIMENTALParticipants enrolled in the current study will use the dose they were assigned to in the feeder study they come from.
Interventions
Participants will continue receiving darolutamide treatment at the dose level and schedule of administration previously assigned in the feeder study.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (335)
Urology Centers of Alabama, PC - Homewood
Homewood, Alabama, 35209, United States
Ironwood Cancer and Research Centers - Chandler I
Chandler, Arizona, 85224, United States
Tower Urology
Los Angeles, California, 90048, United States
Stanford Cancer Center Palo Alto
Palo Alto, California, 94304, United States
San Diego Clinical Trials
San Diego, California, 92120, United States
TOI Clinical Research
Whittier, California, 90603, United States
Rocky Mountain Regional VA Medical Center - Oncology
Aurora, Colorado, 80045, United States
The Urology Center Of Colorado
Denver, Colorado, 80211, United States
Boca Raton Regional Hospital - Oncology
Boca Raton, Florida, 33486, United States
Jesse Brown VA Medical Center - Cardiology
Chicago, Illinois, 60612, United States
Illinois CancerCare - Peoria
Peoria, Illinois, 61615, United States
Norton Cancer Institute - Downtown
Louisville, Kentucky, 40202, United States
Chesapeake Urology Associates - Towson
Baltimore, Maryland, 21204, United States
Johns Hopkins Hospital - Pulmonology
Baltimore, Maryland, 21287, United States
TidalHealth Peninsula Regional, Inc. - Oncology
Salisbury, Maryland, 21801, United States
Henry Ford Hospital - OB/GYN
Detroit, Michigan, 48202, United States
St. Vincent Regional Hospital - Oncology
Billings, Montana, 59102, United States
XCancer Omaha
Omaha, Nebraska, 68130, United States
New Jersey Urology - Voorhees
Voorhees Township, New Jersey, 08043, United States
New Mexico Cancer Center - Albuquerque
Albuquerque, New Mexico, 87109, United States
URMC Wilmot Cancer Center
Rochester, New York, 14642, United States
New York Cancer & Blood Specialists - Eastchester
The Bronx, New York, 10469, United States
Montefiore Einstein Center for Cancer Care - Tower at Montefiore Medical Park
The Bronx, New York, 14061, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
The Urology Group - Norwood Surgery Center
Cincinnati, Ohio, 45212, United States
The Ohio State University - Arthur G James Cancer Hospital and Richard J Solove Research Institute
Columbus, Ohio, 43210, United States
MidLantic Urology - Bala Cynwyd
Bala-Cynwyd, Pennsylvania, 19004, United States
Andrews & Patel Associates
Camp Hill, Pennsylvania, 17011, United States
Charleston Oncology - Downtown
Charleston, South Carolina, 29403, United States
Carolina Urological Research Center
Myrtle Beach, South Carolina, 29579, United States
Urology Associates, PC - Nashville
Nashville, Tennessee, 37209, United States
Urology Clinics of North Texas - Dallas (Walnut HIll Lane)
Dallas, Texas, 75231, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
VCU Health Ambulatory Care Center - Cardiology
Richmond, Virginia, 23284, United States
Providence Regional Cancer Partnership
Everett, Washington, 98201, United States
Inova Schar Cancer Insitute - Inova Fairfax Hospital
Fairfax, Washington, 22031, United States
Centro de Urología
Buenos Aires, Ciudad Auton. de Buenos Aires, C1120AAT, Argentina
Adelaide Cancer Centre Research Pty Ltd
Kurralta Park, South Australia, 5037, Australia
Universitätsklinikum AKH Wien
Vienna, State of Vienna, 1090, Austria
N.N. Alexandrov National Cancer Centre of Belarus - Oncology Department
Lyasny, Minsk Oblast, 223040, Belarus
Minsk City Clinical Oncological Dispensary - Oncology Department
Minsk, Minsk Oblast, 220013, Belarus
GZA Ziekenhuizen
Wilrijk, Antwerpen, 2610, Belgium
AZ Groeninge Campus Kennedylaan
Kortrijk, 8500, Belgium
CHU de Liège
Liège, 4000, Belgium
Instituto do Cancer do Ceará
Fortaleza, Ceará, 60430-230, Brazil
Hospital Evangélico de Cachoeiro de Itapemirim
Cachoeiro de Itapemirim, Espírito Santo, 29308-020, Brazil
Hosp. Araujo Jorge da Associação de Combate ao Câncer
Goiânia, Goiás, 74605-070, Brazil
Clínica de Neoplasias Litoral Ltda
Goiânia, Goiás, 88301-220, Brazil
COT Centro Oncologico do Triangulo Ltda
Uberlândia, Minas Gerais, 38408-150, Brazil
Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner
Curitiba, Paraná, 81520-060, Brazil
Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica
Natal, Rio Grande do Norte, 59040-000, Brazil
Associação Hospitalar Beneficente São Vicente de Paulo
Passo Fundo, Rio Grande do Sul, 99010-080, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400, Brazil
IBCC - Instituto Brasileiro de Controle do Cancer
Jaú, São Paulo, 03102-002, Brazil
Hospital Amaral Carvalho
Jaú, São Paulo, 17210-120, Brazil
Hosp Clínicas Facult. Med. de Ribeirão Preto / USP
Ribeirão Preto, São Paulo, 14051-140, Brazil
Instituto do Cancer do Estado de Sao Paulo
São Paulo, São Paulo, 01246-000, Brazil
Hospital São Rafael
São Paulo, São Paulo, 41253-190, Brazil
Santa Casa de Misericórdia da Bahia
São Paulo, São Paulo, 50040-410, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre | Oncology
São Paulo, São Paulo, 90020-090, Brazil
União Bras. de Edu. e Assist. Hospital São Lucas da PUCRS
São Paulo, São Paulo, 90619-900, Brazil
Medical Center Kalimat
Sofia, Sofia City Province, 1680, Bulgaria
Complex Oncology Center - Vratsa
Vratsa, Vratsa Province, 3000, Bulgaria
Prostate Cancer Centre
Calgary, Alberta, T2V 1P9, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 2Y9, Canada
G. Kenneth Jansz Medicine Professional Corporation
Burlington, Ontario, L7N 3V2, Canada
London Health Sciences Centre
London, Ontario, N5R 6M6, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Hospital-University Health Network
Toronto, Ontario, M5G 2M9, Canada
Centre hospitalier universitaire de Sherbrooke (CHUS) | Oncology
Granby, Quebec, J2G 1T7, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM) | Oncology
Montreal, Quebec, H2X 0C1, Canada
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601, China
Anhui Provincial Hospital
Hefei City, Anhui Province, Anhui, 230031, China
Beijing Cancer Hospital - Oncology Department
Beijing, Beijing Municipality, 100142, China
Beijing Hospital
Beijing, Beijing Municipality, 100730, China
The First Affiliated hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
2nd Affiliated Hosp. of Shantou University Medical College
Shantou, Guangdong, 515021, China
Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.
Wuhan, Hubei, 430030, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Hunan Cancer Hospital - Oncology Department
Changsha, Hunan, 410013, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210000, China
NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
Nanjing, Jiangsu, 210008, China
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029, China
Nantong tumor hospital
Nantong, Jiangsu, 226361, China
The 2nd Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004, China
The First Affiliated Hospital of NanChang University
Nanchang, Jiangxi, 330006, China
The First Hospital of Jilin University
Changchun, Jilin, 130061, China
Liaoning Cancer Hospital and Institute
Shengyang, Liaoning, 110042, China
Qilu Hosp., Shandong Univ.
Jinan, Shandong, 250012, China
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000, China
Shanxi Medical University - First Hospital
Taiyuan, Shanxi, TBC, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061, China
Sichuan University West China Hospital
Chengdu, Sichuan, 610041, China
University of Electronic Science & Technology of China - Sichuan Cancer Hospital & Institute (Sichuan Provincial Tumor Hospital)
Chengdu, Sichuan, 610041, China
ZheJiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, 100000, China
Peking University Third Hospital
Beijing, 100083, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital (SAMSPH)
Chengdu, 610072, China
Chongqing Cancer Hospital
Chongqing, 400030, China
Sun Yat-sen University Cancer Center
Guangzhou, 510000, China
Ningbo First Hospital
Ningbo, 315010, China
The Affiliated Hospital of Qingdao University
Shandong, 266000, China
Fudan University Shanghai Cancer Center - Oncology Department
Shanghai, 200000, China
Ruijin Hosp. Shanghai Jiaotong Univ.School of Medicine
Shanghai, 200025, China
Zhongshan Hospital, Fudan University
Shanghai, 200032, China
Huadong Hospital, Affiliated to Fudan University
Shanghai, 200040, China
Shanghai General Hospital
Shanghai, 200080, China
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen, 518172, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, 300000, China
The Second Hospital of Tianjin Medical University
Tianjin, 300211, China
ZheJiang Provincial People's Hospital
Zhejiang, 314408, China
Hospital Pablo Tobón Uribe
Medellín, Antioquia, 050034, Colombia
Oncomédica S.A.
Montería, Departamento de Córdoba, 230002, Colombia
Fundación Oftalmológica de Santander Carlos Ardila Lule
Floridablanca, Santander Department, 681004, Colombia
Masarykuv onkologicky ustav
Brno, 65653, Czechia
Nemocnice Jablonec nad Nisou
Jablonec nad Nisou, 46601, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 10034, Czechia
Urocentrum Praha, s.r.o.
Prague, 120 00, Czechia
Všeobecná fakultní nemocnice v Praze
Prague, 12808, Czechia
ANDROGEOS, spol. s r.o.
Prague, 160 00, Czechia
Sihtasutus Põhja-Eesti Regionaalhaigla - Onkoloogia- ja hematoloogiakliinik
Tallinn, Harju, 13419, Estonia
Keski-Suomen sairaala Nova
Jyväskylä, Central Finland, 40620, Finland
Oulu University Hospital, Oulun yliopistollinen sairaala (OYS)
Oulu, North Ostrobothnia, 90220, Finland
Tampere University Hospital, Tampereen yliopistollinen sairaala (TAYS)
Tampere, Pirkanmaa, 33520, Finland
Seinäjoen keskussairaala
Seinäjoki, South Ostrobothnia, 60220, Finland
Mikkelin keskussairaala
Mikkeli, South Savo, 50100, Finland
Turun yliopistollinen keskussairaala
Turku, Southwest Finland, 20520, Finland
HUS, Meilahden sairaala
Helsinki, Uusimaa, 00029, Finland
Centre Jean Perrin
Clermont-Ferrand, Auvergne-Rhône-Alpes, 63011, France
HCL - Centre Hospitalier Lyon Sud
Pierre-Bénite, Auvergne-Rhône-Alpes, 69495, France
Centre d'Oncologie et de Radiologie du Parc
Dijon, Bourgogne-Franche-Comté, 21000, France
Clinique Lanroze
Brest, Brittany Region, 29200, France
CHU Rennes - Hopital Pontchaillou
Rennes, Brittany Region, 35033, France
CHU Tours - Hopital Bretonneau
Tours, Centre-Val de Loire, 37044, France
Institut de Cancerologie Jean Godinot - Departement oncologie medicale
Reims, Grand Est, 51056, France
Hôpital Charles Nicolle
Rouen, Normandy, 76031, France
Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale
Bordeaux, Nouvelle-Aquitaine, 33000, France
Hôpital de la Milétrie
Poitiers, Nouvelle-Aquitaine, 86021, France
ICM - Institut du Cancer de Montpellier - Val d'Aurelle
Montpellier, Occitanie, 34298, France
Centre Hospitalier Universitaire - Angers
Angers, Pays de la Loire Region, 49933, France
Hopital Hotel Dieu - Nantes
Nantes, Pays de la Loire Region, 44000, France
Institut de Cancerologie Ouest - Saint-Herblain
Saint-Herblain, Pays de la Loire Region, 44800, France
Institut Paoli-Calmettes - Marseille
Marseille, Provence-Alpes-Côte d'Azur Region, 13273, France
Hôpital Saint Louis
Paris, Île-de-France Region, 75010, France
Hôpital d'Instruction des Armées Begin
Saint-Mandé, Île-de-France Region, 94160, France
Centre Médico-Chirurgical Foch
Suresnes, Île-de-France Region, 92151, France
Gustave Roussy - Departement Oncologie-Radiotherapie
Villejuif, Île-de-France Region, 94805, France
Urologische Gemeinschaftspraxis Carl-Andreas-Meilinger
Emmendingen, Baden-Wurttemberg, 79312, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Urologische Gemeinschaftspraxis Muehlacker
Mühlacker, Baden-Wurttemberg, 75417, Germany
Studienpraxis Urologie
Nürtingen, Baden-Wurttemberg, 72622, Germany
Urologische Gemeinschaftspraxis Dr. Simone Maier
Reutlingen, Baden-Wurttemberg, 72764, Germany
Uniklinik Tübingen / Urologie
Tübingen, Baden-Wurttemberg, 72076, Germany
Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054, Germany
Städtisches Klinikum Braunschweig GmbH
Braunschweig, Lower Saxony, 38126, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Praxis Drs. Tim Schneider /B. Schneider
Mülheim, North Rhine-Westphalia, 45468, Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, 48149, Germany
Uro-Gyn-Zentrum Wall Hr. Dr. Jochen Gleißner
Wuppertal, North Rhine-Westphalia, 42103, Germany
Universitätsmedizin der Johannes Gutenberg Universität Mainz
Mainz, Rhineland-Palatinate, 55101, Germany
Medizinische Fakultät der Otto-von-Guericke Universität
Magdeburg, Saxony-Anhalt, 39120, Germany
Friedrich-Schiller-Uni. Jena
Jena, Thuringia, 7747, Germany
Tolna Vármegyei Balassa János Kórház
Szekszárd, 7100, Hungary
Zala Varmegyei Szent Rafael Korhaz
Zalaegerszeg, 8900, Hungary
Clalit Health | Soroka Medical Center - Internal Medicine Department
Beersheba, 8410101, Israel
Rabin Medical Center | Beilinson Hospital - Internal Medicine C Department
Petah Tikva, 4941492, Israel
Health Corporation of the Ziv Medical Center (R.A.)
Safed, 1311001, Israel
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Naples, Campania, 80131, Italy
Azienda Ospedaliero Universitaria Parma
Parma, Emilia-Romagna, 43126, Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Oncologia Medica
Orbassano, Piedmont, 10043, Italy
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Turin, Piedmont, 10060, Italy
Istituto Oncologico Veneto_Padova - UOC Oncologia 1
Padova, Veneto, 35128, Italy
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560, Japan
Asahi General Hospital
Asahi, Chiba, 289-2511, Japan
Toho University Sakura Medical Center
Sakura, Chiba, 285-8741, Japan
Gunma University Hospital
Maebashi, Gunma, 371-8511, Japan
Sapporo Medical University Hospital
Sapporo, Hokkaido, 060-8543, Japan
Kobe University Hospital
Kobe, Hyōgo, 650-0017, Japan
National hospital Organization Mito Medical Center
Higashiibaraki, Ibaraki, 311-3193, Japan
Kitasato University Hospital
Sagamihara, Kanagawa, 252-0375, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, 232-0024, Japan
Yokosuka Kyosai Hospital
Yokosuka, Kanagawa, 238-8558, Japan
Mie University Hospital
Tsu, Mie-ken, 514-8507, Japan
National Hospital Organization Shinshu Ueda Medical Center
Ueda, Nagano, 386-8610, Japan
Oita University Hospital
Yufu, Oita Prefecture, 879-5593, Japan
Osaka International Cancer Institute
Osaka, Osaka, 541-8567, Japan
Kindai University Hospital
Sakai, Osaka, 590-0197, Japan
The University of Osaka Hospital
Suita, Osaka, 565-0871, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, 431-3192, Japan
Saiseikai Utsunomiya Hospital
Utsunomiya, Tochigi, 321-0974, Japan
Nippon Medical School Hospital
Bunkyo-Ku, Tokyo, 113-0022, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431, Japan
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Itabashi-ku, Tokyo, 173-0015, Japan
Kyorin University Hospital
Mitaka, Tokyo, 181-8611, Japan
Tokyo Metropolitan Police Hospital
Nakano-ku, Tokyo, 164-8541, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582, Japan
The Fraternity Memorial Hospital
Sumida-ku, Tokyo, 130-8587, Japan
Tottori University Hospital
Yonago, Tottori, 683-8504, Japan
Yamaguchi University Hospital
Ube, Yamaguchi, 755-8505, Japan
Chiba Cancer Center
Chiba, 260-8717, Japan
Gifu Prefectural General Medical Center
Gifu, 500-8717, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, 730-8518, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, 860-0008, Japan
University of Miyazaki Hospital
Miyazaki, 889-1692, Japan
Nagasaki University Hospital
Nagasaki, 852-8501, Japan
Osaka General Medical Center
Osaka, 558-8558, Japan
Toyama University Hospital
Toyama, 930-0194, Japan
Wakayama Medical University Hospital
Wakayama, 640-8558, Japan
Daugavpils Regional Hospital
Daugavpils, Daugavpils City, LV-5417, Latvia
Litavniece Dzintra practice in urology and oncological chem.
Liepāja, Liepaja City, LV-3401, Latvia
P. Stradins Clinical University Hospital
Riga, Riga City, LV-1002, Latvia
AS "Association of Health Centers" polyclinic "Elite"
Riga, Riga City, LV-1029, Latvia
Riga East Clinical University Hospital "Gailezers"
Riga, Riga City, LV-1038, Latvia
Vidzemes Hospital
Valmiera, Valmiera City, LV-4201, Latvia
Hospital of LT University of Health Sciences Kaunas Clinics
Kaunas, LT-50161, Lithuania
PI Klaipedos University Hospital
Klaipėda, LT-92288, Lithuania
National Cancer Institute
Vilnius, LT-08660, Lithuania
Vilnius University Hospital Santaros Klinikos
Vilnius, LT-08661, Lithuania
Hospital Universitario "José Eleuterio González"
Monterrey, Nuevo León, 64460, Mexico
INBIOMEDyC Querétaro
Querétaro City, Querétaro, 76000, Mexico
Zuyderland Medical Centre | Internal Medicine Department
Geleen, Limburg, 6162 BG, Netherlands
ETZ TweeSteden Ziekenhuis (vh Maria Ziekenhuis)
Tilburg, North Brabant, 5042 AD, Netherlands
Academisch Medisch Centrum (AMC)
Amsterdam, North Holland, 1105 AZ, Netherlands
Tergooi MC | Hilversum - Wetenschapsbureau
Hilversum, North Holland, 1213 VG, Netherlands
Spaarne Gasthuis
Hoofddorp, North Holland, 2134 TM, Netherlands
Albert Schweitzer Ziekenhuis | Dordwijk - Cardiology Department
Dordrecht, South Holland, 3318 AT, Netherlands
HagaZiekenhuis
The Hague, South Holland, 2545 CH, Netherlands
Centro Médico Monte Carmelo - Oncology Department
La Victoria, Lima Province (Provincia de Lima), 15036, Peru
Instituto Peruano de Oncología & Radioterapia - Oncologia SA - Oncology Department
Lima, Lima Province (Provincia de Lima), 15036, Peru
Hospital Central de la Fuerza Aerea del Perú
Lima, Lima Province (Provincia de Lima), 15046, Peru
ETG Network Spolka z o.o.
Lodz, 90-302, Poland
KO-MED Centra Kliniczne Lublin II
Lublin, 20-362, Poland
Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina
Otwock, 05-400, Poland
Urologica Praktyka Lekarska Adam Marcheluk
Siedlce, 08-110, Poland
Szpital Grochowski im. dr.med. Rafala Masztaka
Warsaw, 04-073, Poland
Unidade Local de Saude Almada-Seixal | Hospital Garcia de Orta - Research Department
Almada, Setúbal District, 2805-267, Portugal
IPO Lisboa
Lisbon, 1099-023, Portugal
CHLC - Hospital Sao Jose
Lisbon, 1150-199, Portugal
Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica
Lisbon, 1500-650, Portugal
IPO Porto
Porto, 4200-072, Portugal
Unidade Local de Saúde de São João E.P.E. - Hospital São João - Serviço de Urologia
Porto, 4200-319, Portugal
Spitalul Clinic Judetean Mures
Târgu Mureş, Mure?, 540103, Romania
Institutul Clinic Fundeni, sectia Nefrologie Clinica
Bucharest, 22328, Romania
Ltd "EVIMED"
Chelyabinsk, 454048, Russia
Chelyabinsk Regional Oncology Dispensary
Chelyabinsk, 454087, Russia
Ivanovo Regional Oncology Dispensary
Ivanovo, 153040, Russia
Republican Clinical Oncology Dispensary Kazan
Kazan', 420029, Russia
Krasnoyarsk Regional Clinical Oncology Dispensary
Krasnoyarsk, 660133, Russia
Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS
Moscow, 115478, Russia
Moscow Scient. Res. Institute of Oncology n.a P.A. Hertzen
Moscow, 125284, Russia
City Outpatient Clinic #1 of Privolzhsky Regional Med. Cent.
Nizhny Novgorod, 603001, Russia
LLC Reafan
Novosibirsk, 630099, Russia
Medical Center "Avicenna"
Novosibirsk, 630099, Russia
National Medical Research Radiology Center
Obninsk, 249036, Russia
Clinical Oncological Dispensary of Omsk Region
Omsk, 644013, Russia
Leningrad Regional Oncology Dispensary
Saint Petersburg, 188663, Russia
Saratov State Medical University
Saratov, 410054, Russia
Multi-Field Clinical Medical Center "Medical City"
Tyumen, 625041, Russia
Regional Clinical Oncology Dispensary
Vladimir, 600009, Russia
Clinical Hospital Center Bezanijska kosa
Belgrade, 11080, Serbia
Clinical Center Nis
Niš, 18000, Serbia
J. BREZA MEDICAL s. r. o.
Bratislava, 851 01, Slovakia
CUIMED s.r.o
Bratislava, 85101, Slovakia
Langehoven Drive Oncology Centre
Port Elizabeth, Eastern Cape, 6045, South Africa
University of Pretoria, Clinical Research Unit
Pretoria, Gauteng, 2, South Africa
Dept Radiation and Oncology Tygerberg Academic Hospital
Cape Town, Western Cape, 7505, South Africa
Cape Gate Oncology Centre
Cape Town, Western Cape, 7570, South Africa
Cancercare Outeniqua
George, Western Cape, 6529, South Africa
Cancercare Rondebosch Oncology
Rondebosch, Western Cape, 7700, South Africa
Chonnam National University Hospital | Urology
Gwangju, Gwangju Gwang''yeogsi, 501-757, South Korea
Chungbuk National University Hospital-Department of Urology
Chungcheongbuk-do, North Chungcheong, 28644, South Korea
Seoul National University Hospital-Department of Urology
Seoul, Seoul Teugbyeolsi, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi, 03722, South Korea
Asan Medical Center | Urology
Seoul, Seoul Teugbyeolsi, 05505, South Korea
Gangnam Severance Hospital, Yonsei University Health System-Department of Urology
Seoul, Seoul Teugbyeolsi, 06273, South Korea
Keimyung University Dongsan Medical Center
Daegu, 42601, South Korea
Kyungpook National University Chilgok Hospital
Daegu, 700721, South Korea
Gachon University Gil Medical Center-Department of Urology
Incheon, 21565, South Korea
Samsung Medical Center - Oncology Department
Seoul, 06351, South Korea
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, 137-701, South Korea
Hospital General Universitario De Elche | Urologia
Elche, Alicante, 3203, Spain
Hospital De Manacor | Urologia
Manacor, Balearic Islands, 7500, Spain
Hospital Universitari Son Espases | Oncologia
Palma de Mallorca, Balearic Islands, 7120, Spain
Parc Tauli Hospital Universitari | Oncologia
Sabadell, Barcelona, 08208, Spain
Hospital Universitario Fundacion Alcorcon | Urologia
Alcorcón, Madrid, 28922, Spain
Hospital del Mar I Oncologia
Barcelona, 08003, Spain
Hospital Universitari Vall D Hebron | Oncologia
Barcelona, 08035, Spain
Hospital Clinic De Barcelona | Urologia
Barcelona, 8036, Spain
Hospital De La Santa Creu I Sant Pau | Oncologia
Barcelona, 8041, Spain
Bellvitge Hospital Universitari | Urologia
Barcelona, 8908, Spain
Hospital San Pedro De Alcantara | Oncologia
Cáceres, 10003, Spain
Hospital Universitario Reina Sofia | Oncologia
Córdoba, 14004, Spain
Hospital Universitario Lucus Augusti | Urologia
Lugo, 27003, Spain
Hospital General Universitario Gregorio Maranon | Urologia
Madrid, 28009, Spain
Hospital Universitario Ramon Y Cajal | Oncologia
Madrid, 28034, Spain
Hospital Clinico San Carlos | Oncologia
Madrid, 28040, Spain
Hospital Universitario Fundacion Jimenez Diaz | Urologia
Madrid, 28040, Spain
Hospital Universitario 12 De Octubre | Urologia
Madrid, 28041, Spain
Hospital Universitario Virgen De La Victoria | Oncologia
Málaga, 29010, Spain
Hospital Universitario Virgen Del Rocio S.L. | Oncologia
Seville, 41013, Spain
Fundacion Instituto Valenciano De Oncologia | Urologia
Valencia, 46009, Spain
Hospital Arnau De Vilanova De Valencia | Oncologia
Valencia, 46015, Spain
Karolinska Universitetssjukhuset
Stockholm, Stockholm County, 171 76, Sweden
Akademiska Sjukhuset
Uppsala, Uppsala County, 752 37, Sweden
Norrlands Universitetssjukhus, Umea
Umeå, Västerbotten County, 901 85, Sweden
Sahlgrenska Universitetssjukhuset
Gothenburg, Västra Götaland County, 413 45, Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807377, Taiwan
China Medical University Hospital
Taichung, 404327, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Chang Gung Memorial Hospital at Linkou
Taoyuan District, 33305, Taiwan
Gazi Universitesi Tip Fakultesi
Ankara, 6560, Turkey (Türkiye)
CNE "Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of the Cherkasy Regional Council"
Cherkasy, 18009, Ukraine
Regional communal non-profit enterprise 'Chernivtsi regional clinical hospital' - Urological department
Chernivtsi, 58001, Ukraine
Municipal Non-commercial Enterprise 'City Clinical Hospital #4' of Dnipro City Council - City ?hemotherapy ?enter
Dnipro, 49102, Ukraine
Regional Medical Clinical Center of Urology and Nephrology n.a. V. I. Shapoval - Department of Oncologic Urology #5
Kharkiv, 61037, Ukraine
Kyiv City Hospital #3 - Department of Urology
Kyiv, 02660, Ukraine
SE "Academician O.F. Vozianov Institute of Urology" of NAMSU - Division of Reconstructive Urology and Advanced Technologies
Kyiv, 252053, Ukraine
Zakarpattia Anti-Tumor Centre - Chemotherapy Department
Uzhhorod, 88014, Ukraine
Royal Berkshire NHS Foundation Trust¦Royal Berkshire Hospital - Oncology
Reading, Berkshire, RG1 5AN, United Kingdom
East Suffolk and North Essex NHS Foundation Trust¦Colchester General Hospital - Oncology Trials Unit
Colchester, Essex, CO45JR, United Kingdom
University College London Hospitals NHS Foundation Trust
London, Greater London, NW1 2PG, United Kingdom
Charing Cross Hospital
London, Greater London, W6 8RF, United Kingdom
Clatterbridge Centre for Oncology
Bebington, Merseyside, CH63 4JY, United Kingdom
Scunthorpe General Hospital
Scunthorpe, North East Lincolnshire, DN15 7BH, United Kingdom
NHS Greater Glasgow & Clyde | Beatson West of Scotland Cancer Centre - Clinical Research Unit
Glasgow, Scotland, G12 0YN, United Kingdom
Cardiff and Vale University Health Board | University Hospital of Wales - Nephrology and Transplant
Cardiff, Wales, CF14 4XW, United Kingdom
Prince Philip Hospital
Llanelli, Wales, SA14 8QF, United Kingdom
Dudley Group NHS Foundation Trust ¦Russells Hall Hopsital - Oncology
Dudley, West Midlands, DY1 2HQ, United Kingdom
Calderdale and Huddersfield NHS Foundation Trust¦Huddersfield Royal Infirmary - Oncology
Huddersfield, West Yorkshire, HD3 3EA, United Kingdom
Mid Yorkshire Teaching NHS Trust¦Pinderfields Hospital - Oncology
Wakefield, West Yorkshire, WF1 4DG, United Kingdom
MeSH Terms
Conditions
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2020
First Posted
July 9, 2020
Study Start
October 20, 2020
Primary Completion (Estimated)
June 26, 2028
Study Completion (Estimated)
June 26, 2028
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
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.