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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04464226
Other study ID # 20321
Secondary ID 2019-003618-15
Status Recruiting
Phase Phase 3
First received
Last updated
Start date October 20, 2020
Est. completion date June 25, 2025

Study information

Verified date May 2024
Source Bayer
Contact Bayer Clinical Trials Contact
Phone (+)1-888-84 22937
Email clinical-trials-contact@bayer.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 678
Est. completion date June 25, 2025
Est. primary completion date June 25, 2025
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Darolutamide (Nubeqa, BAY1841788)
Participants will continue receiving darolutamide treatment at the dose level and schedule of administration previously assigned in the feeder study.

Locations

Country Name City State
Argentina Centro de Urología Buenos Aires Ciudad Auton. De Buenos Aires
Australia Adelaide Cancer Centre Research Pty Ltd Kurralta Park South Australia
Austria Universitätsklinikum AKH Wien Wien
Belarus N.N. Alexandrov National Cancer Centre of Belarus - Oncology Department Lesnoy
Belarus Minsk City Clinical Oncological Dispensary - Oncology Department Minsk
Belgium CU Saint-Luc/UZ St-Luc Bruxelles - Brussel
Belgium UZ Gent Gent
Belgium AZ Groeninge Campus Kennedylaan Kortrijk
Belgium CHU de Liège Liege
Belgium CHU UCL Namur Namur
Belgium GZA Ziekenhuizen Wilrijk Antwerpen
Brazil Fundacao Pio XII Hospital de Cancer de Barretos Barretos/SP Sao Paulo
Brazil Hospital Evangélico de Cachoeiro de Itapemirim Cachoeiro de Itapemirim Espírito Santo
Brazil Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner Curitiba Parana
Brazil Instituto do Cancer do Ceará Fortaleza Ceará
Brazil Hosp. Araujo Jorge da Associação de Combate ao Câncer Goiânia Goiás
Brazil Clínica de Neoplasias Litoral Ltda Itajaí Santa Catarina
Brazil Hospital Amaral Carvalho Jaú Sao Paulo
Brazil Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica Natal Rio Grande Do Norte
Brazil Associação Hospitalar Beneficente São Vicente de Paulo Passo Fundo Rio Grande Do Sul
Brazil Irmandade da Santa Casa de Misericordia de Porto Alegre | Hospital Sao Francisco - Centro Medico Pesquisa Clinica Cardiologia Porto Alegre Rio Grande Do Sul
Brazil União Bras. de Edu. e Assist. Hospital São Lucas da PUCRS Porto Alegre Rio Grande Do Sul
Brazil Hosp Clínicas Facult. Med. de Ribeirão Preto / USP Ribeirão Preto/SP Sao Paulo
Brazil Hospital São Rafael Salvador Bahia
Brazil Santa Casa de Misericórdia da Bahia Salvador Bahia
Brazil IBCC - Instituto Brasileiro de Controle do Cancer São Paulo Sao Paulo
Brazil IEP São Lucas São Paulo Sao Paulo
Brazil Inst. de Assistência Médica ao Sérvidor Público Estadual São Paulo Sao Paulo
Brazil Instituto do Cancer do Estado de Sao Paulo São Paulo Sao Paulo
Brazil COT Centro Oncologico do Triangulo Ltda Uberlandia Minas Gerais
Bulgaria Medical Center Kalimat Sofia
Bulgaria Complex Oncology Center - Vratsa Vratsa
Canada G. Kenneth Jansz Medicine Professional Corporation Burlington Ontario
Canada Prostate Cancer Centre Calgary Alberta
Canada Cross Cancer Institute Edmonton Alberta
Canada CIUSSS de l'Estrie- Centre Haute-Yamaska Granby Quebec
Canada Nova Scotia Health Authority Halifax Nova Scotia
Canada Kingston Health Sciences Centre Kingston Ontario
Canada London Health Sciences Centre London Ontario
Canada Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopi Montreal Quebec
Canada Princess Margaret Hospital-University Health Network Toronto Ontario
Canada Sunnybrook Health Sciences Centre Toronto Ontario
China Beijing Cancer Hospital Beijing
China Beijing Cancer Hospital Beijing
China Beijing Hospital Beijing
China Hunan Cancer Hospital Changsha Hunan
China Chongqing Cancer Hospital Chongqing
China ZheJiang Provincial People's Hospital Hangzhou Zhejiang
China Anhui Provincial Hospital Hefei City, Anhui Province Anhui
China Qilu Hosp., Shandong Univ. Jinan Shandong
China Jiangsu Cancer Hospital Nanjing Jiangsu
China Fudan University Shanghai Cancer Center Shanghai
China Huadong Hospital, Affiliated to Fudan University Shanghai
China Zhongshan Hospital, Fudan University Shanghai
China Liaoning Cancer Hospital and Institute Shengyang Liaoning
China Tianjin Medical University Cancer Institute & Hospital Tianjin
China The First Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang
China Hubei Cancer Hospital Wuhan Hubei
China Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech. Wuhan Hubei
China The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi
China The First Affiliated Hospital of Xiamen University Xiamen Fujian
Colombia Fundación Oftalmológica de Santander Carlos Ardila Lule Florida Blanca Santander
Colombia Hospital Pablo Tobón Uribe Medellín Antioquia
Colombia Oncomédica S.A. Montería Córdoba
Czechia Masarykuv onkologicky ustav Brno
Czechia Nemocnice Jablonec nad Nisou Jablonec nad Nisou
Czechia Fakultni nemocnice Kralovske Vinohrady Praha 10
Czechia Urocentrum Praha, s.r.o. Praha 2
Czechia Vseobecna fakultni nemocnice v Praze Praha 2
Czechia Androgeos - private center of urology and andrology Praha 6
Estonia North Estonia Medical Centre Foundation Tallinn
Finland HUS, Meilahden sairaala Helsinki
Finland Keski-Suomen sairaala Nova Jyväskylä
Finland Mikkelin keskussairaala Mikkeli
Finland Oulun yliopistollinen sairaala Oulu
Finland Seinäjoen keskussairaala Seinäjoki
Finland Tampereen yliopistollinen sairaala, keskussairaala Tampere
Finland Turun yliopistollinen keskussairaala Turku
Finland Turun yliopistollinen keskussairaala Turku
France Centre Hospitalier Universitaire - Angers Angers
France Institut Bergonié - Unicancer Nouvelle Aquitaine Bordeaux
France Clinique Lanroze Brest
France Centre Jean Perrin Clermont-ferrand
France Centre d'Oncologie et de Radiologie du Parc Dijon
France Institut Paoli-Calmettes - Marseille Marseille
France Institut du Cancer de Montpellier - Val d'Aurelle Montpellier Cedex
France Centre d'Oncologie de Gentilly Nancy
France Hopital Hotel Dieu - Nantes Nantes Cedex
France Hôpital Saint Louis Paris
France Centre Hospitalier Lyon Sud Pierre Benite
France Hôpital de la Milétrie Poitiers
France Institut de Cancérologie Jean Godinot Reims
France Hôpital Pontchaillou Rennes Cedex
France Hôpital Charles Nicolle Rouen
France Hôpital d'Instruction des Armées Begin Saint Mande
France Institut de Cancérologie de l'Ouest - Saint Herblain Saint-Herblain
France Centre Médico-Chirurgical Foch Suresnes
France Hôpital Bretonneau Tours
France Institut Gustave Roussy - Département de Médecine Oncologique Villejuif Cedex
Germany Städtisches Klinikum Braunschweig gGmbH Braunschweig Niedersachsen
Germany Heinrich-Heine-Universität Düsseldorf Düsseldorf Nordrhein-Westfalen
Germany Urologische Gemeinschaftspraxis Carl-Andreas-Meilinger Emmendingen Baden-Württemberg
Germany Universitätsklinikum Erlangen Erlangen Bayern
Germany Universitätsklinikum der Johann Wolfgang Goethe Universität Frankfurt Hessen
Germany Universitätsklinikum Freiburg Freiburg Baden-Württemberg
Germany Gesundheitszentrum Holzminden Holzminden Niedersachsen
Germany Friedrich-Schiller-Uni. Jena Jena Thüringen
Germany Urologische GemPraxis Dr. R. Rudolph Kirchheim unter Teck Baden-Württemberg
Germany Medizinische Fakultät der Otto-von-Guericke Universität Magdeburg Sachsen-Anhalt
Germany Universitätsmedizin der Johannes Gutenberg Universität Mainz Mainz Rheinland-Pfalz
Germany Urologische Gemeinschaftspraxis Muehlacker Muehlacker Baden-Württemberg
Germany Praxis Drs. Tim Schneider /B. Schneider Mühlheim Nordrhein-Westfalen
Germany Universitätsklinikum Münster (UKM) Münster Nordrhein-Westfalen
Germany Studienpraxis Urologie Nürtingen Baden-Württemberg
Germany Urologische Gemeinschaftspraxis Dr. Simone Maier Reutlingen Baden-Württemberg
Germany Uniklinik Tübingen / Urologie Tübingen Baden-Württemberg
Germany Universitätsklinikum Ulm Ulm Baden-Württemberg
Germany Uro-Gyn-Zentrum Wall Hr. Dr. Jochen Gleißner Wuppertal Nordrhein-Westfalen
Hungary Debreceni Egyetem Klinikai Kozpont Debrecen
Hungary Tolna Varmegyei Balassa Janos Korhaz Szekszard
Hungary Zala Varmegyei Szent Rafael Korhaz Zalaegerszeg
Israel Soroka University Medical Center Beer Sheva
Israel Clalit Health Services Rabin Medical Center-Beilinson Campus Petah Tikva
Israel Health Corporation of the Ziv Medical Center (R.A.) Zefat
Italy Istituto Nazionale Tumori IRCCS Fondazione G.Pascale Napoli Campania
Italy Istituto Oncologico Veneto IRCCS (IOV) Padova Veneto
Italy A.O.U. di Parma Parma Emilia-Romagna
Italy A.O.U. San Luigi Gonzaga Torino Piemonte
Italy IRCCS Fondazione del Piemonte per l'Oncologia Torino Piemonte
Japan Asahi General Hospital Asahi Chiba
Japan Juntendo University Hospital Bunkyo-ku Tokyo
Japan Nippon Medical School Hospital Bunkyo-ku Tokyo
Japan Chiba Cancer Center Chiba
Japan Gifu Prefectural General Medical Center Gifu
Japan Hamamatsu University Hospital Hamamatsu Shizuoka
Japan National hospital Organization Mito Medical Center Higashiibaraki Ibaraki
Japan Hiroshima City Hiroshima Citizens Hospital Hiroshima
Japan Tokyo Metropolitan Institute for Geriatrics and Gerontology Itabashi-ku Tokyo
Japan National Cancer Center Hospital East Kashiwa
Japan Kobe University Hospital Kobe Hyogo
Japan National Hospital Organization Kumamoto Medical Center Kumamoto
Japan Gunma University Hospital Maebashi Gunma
Japan Kyorin University Hospital Mitaka Tokyo
Japan University of Miyazaki Hospital Miyazaki
Japan Nagasaki University Hospital Nagasaki
Japan Nagoya University Hospital Nagoya Aichi
Japan Tokyo Metropolitan Police Hospital Nakano-ku Tokyo
Japan Osaka General Medical Center Osaka
Japan Osaka International Cancer Institute Osaka
Japan Osaka Metropolitan University Hospital Osaka
Japan Kindai University Hospital Osakasayama Osaka
Japan Kitasato University Hospital Sagamihara Kanagawa
Japan Toho University Sakura Medical Center Sakura Chiba
Japan Sapporo Medical University Hospital Sapporo Hokkaido
Japan Keio University Hospital Shinjuku-ku Tokyo
Japan Osaka University Hospital Suita Osaka
Japan The Fraternity Memorial Hospital Sumida-ku Tokyo
Japan Toyama University Hospital Toyama
Japan Mie University Hospital Tsu Mie
Japan Yamaguchi University Hospital Ube Yamaguchi
Japan National Hospital Organization Shinshu Ueda Medical Center Ueda Nagano
Japan Saiseikai Utsunomiya Hospital Utsunomiya Tochigi
Japan Wakayama Medical University Hospital Wakayama
Japan Yokohama City University Medical Center Yokohama Kanagawa
Japan Yokosuka Kyosai Hospital Yokosuka Kanagawa
Japan Tottori University Hospital Yonago Tottori
Japan Oita University Hospital Yufu Oita
Korea, Republic of Inje University Busan Paik Hospital Busan
Korea, Republic of Chungbuk National University Hospital Cheongju-si Chungcheongbugdo
Korea, Republic of Keimyung University Dongsan Medical Center Daegu
Korea, Republic of Kyungpook National University Chilgok Hospital Daegu
Korea, Republic of Chonnam National University Hospital Donggu, Gwangju Gwang''yeogsi
Korea, Republic of Gachon University Gil Medical Center Incheon
Korea, Republic of Seoul National Univ. Bundang Hospital Seongnam-si Gyeonggido
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Gangnam Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul Seoul Teugbyeolsi
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of The Catholic University of Korea Seoul St. Mary's Hospital Seoul
Latvia Litavniece Dzintra practice in urology and oncological chem. Liepaja
Latvia AS "Association of Health Centers" polyclinic "Elite" Riga
Latvia P. Stradins Clinical University Hospital Riga
Latvia Riga East Clinical University Hospital "Gailezers" Riga
Latvia URO Ltd. Riga
Lithuania Hospital of LT University of Health Sciences Kaunas Clinics Kaunas
Lithuania PI Klaipedos University Hospital Klaipeda
Lithuania National Cancer Institute Vilnius
Lithuania Vilnius University Hospital Santaros Klinikos Vilnius
Mexico Hospital Universitario "José Eleuterio González" Monterrey Nuevo Leon
Mexico INBIOMEDyC Querétaro Santiago de Querétaro Querétaro
Netherlands Academisch Medisch Centrum (AMC) Amsterdam
Netherlands Nederlands Kanker Instituut Amsterdam
Netherlands HagaZiekenhuis Den Haag
Netherlands Albert Schweitzer Ziekenhuis | Dordwijk - Cardiology Department Dordrecht
Netherlands Zuyderland Medical Centre | Internal Medicine Department Geleen
Netherlands Tergooi MC | Hilversum - Wetenschapsbureau Hilversum
Netherlands Spaarne Gasthuis Hoofddorp
Netherlands ETZ TweeSteden Ziekenhuis (vh Maria Ziekenhuis) Tilburg
Peru Centro Médico Monte Carmelo - Oncology Department La Victoria Arequipa
Peru Hospital Central de la Fuerza Aerea del Perú Lima
Peru Instituto Peruano de Oncología & Radioterapia - Oncologia SA - Oncology Department Lima
Poland Uniwersyteckie Centrum Kliniczne Gdansk
Poland ETG Network Spolka z o.o. Lodz
Poland KO-MED Centra Kliniczne Lublin II Lublin
Poland Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina Otwock
Poland SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 Rybnik
Poland Urologica Praktyka Lekarska Adam Marcheluk Siedlce
Poland Mazowiecki Szpital Onkologiczny Waliszew
Poland Centrum Onkologii - Instytut im. M.Sklodowskiej-Curie Warszawa
Poland Szpital Grochowski im. dr.med. Rafala Masztaka Warszawa
Poland EMC Instytut Medyczny SA Wroclaw
Portugal Hospital Garcia de Orta | Research Department Almada Lisboa
Portugal CHLC - Hospital Sao Jose Lisboa
Portugal IPO Lisboa Lisboa
Portugal Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica Lisboa
Portugal ULSM - Hospital Pedro Hispano Matosinhos Porto
Portugal CHUSJ - Hospital Sao Joao Porto
Portugal IPO Porto Porto
Romania Institutul Clinic Fundeni Bucuresti
Romania Sf. Nectarie Oncology Center Craiova
Romania Spitalul Clinic Judetean de Urgenta Oradea Oradea
Romania Spitalul Clinic Judetean Mures Targu-Mures
Russian Federation Chelyabinsk Regional Oncology Dispensary Chelyabinsk
Russian Federation Ltd "EVIMED" Chelyabinsk
Russian Federation Ivanovo Regional Oncology Dispensary Ivanovo
Russian Federation Republican Clinical Oncology Dispensary Kazan Kazan
Russian Federation Krasnoyarsk Regional Clinical Oncology Dispensary Krasnoyarsk
Russian Federation City clinical hospital #40 Moscow Moscow
Russian Federation Moscow Scient. Res. Institute of Oncology n.a P.A. Hertzen Moscow
Russian Federation Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS Moscow
Russian Federation City Outpatient Clinic #1 of Privolzhsky Regional Med. Cent. Nizhny Novgorod
Russian Federation LLC Reafan Novosibirsk
Russian Federation Medical Center "Avicenna" Novosibirsk
Russian Federation National Medical Research Radiology Center Obninsk
Russian Federation Clinical Oncological Dispensary of Omsk Region Omsk
Russian Federation Rostov State Medical University Rostov-on-Don
Russian Federation Saratov State Medical University Saratov
Russian Federation Leningrad Regional Oncology Dispensary St. Petersburg
Russian Federation St. Petersburg Clinical Hospital of RAS St. Petersburg
Russian Federation St. Petersburg Medical University n.a. I.P. Pavlov St. Petersburg
Russian Federation Multi-Field Clinical Medical Center "Medical City" Tyumen
Russian Federation Regional Clinical Oncology Dispensary Vladimir
Serbia Clinical Hospital Center Bezanijska kosa Belgrade
Serbia Clinical Center Nis Nis
Slovakia CUIMED s.r.o Bratislava
Slovakia J. BREZA MEDICAL s. r. o. Bratislava
Slovakia Privatna urologicka ambulancia, s.r.o. Trencin
South Africa Dept Radiation and Oncology Tygerberg Academic Hospital Cape Town Western Cape
South Africa Cancercare Outeniqua George Eastern Cape
South Africa Cancercare Rondebosch Oncology Rondebosch Western Cape
Spain Fundación Hospital Alcorcón Alcorcón Madrid
Spain Ciutat Sanitaria i Universitaria de la Vall d'Hebron Barcelona
Spain Hospital Clínic i Provincial de Barcelona Barcelona
Spain Hospital de la Santa Creu i de Sant Pau | Oncología Barcelona
Spain Hospital del Mar Barcelona
Spain Hospital San Pedro de Alcántara Cáceres
Spain Hospital Reina Sofía Córdoba
Spain Hospital General de Elche Elche Alicante
Spain Hospital SAS de Jerez de la Frontera Jerez de la Frontera Cádiz
Spain Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Cardiology - AF, Stroke Prevention L'Hospitalet de Llobregat Barcelona
Spain Hospital Lucus Augustí Lugo
Spain Fundacion Jimenez Diaz (Clinica de la Concepcion) Madrid
Spain Hospital Clinico Universitario San Carlos | Oncologia Madrid
Spain Hospital General Universitario Gregorio Maranon | Oncologia Madrid
Spain Hospital Ramón y Cajal | Oncología Madrid
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario Virgen de la Victoria | Oncology Málaga
Spain Hospital de Manacor Manacor Illes Baleares
Spain Hospital Universitari Son Espases Palma de Mallorca Illes Baleares
Spain Corporació Sanitària Parc Taulí Sabadell Barcelona
Spain Hospital Clínico de Salamanca Salamanca
Spain H Virgen del Rocio |Cardiology|AF|Stroke prevention Sevilla
Spain Hospital Arnau de Vilanova de Valencia Valencia
Spain Instituto Valenciano de Oncología Valencia
Sweden Sahlgrenska Universitetssjukhuset Göteborg
Sweden Skånes Universitetssjukhus Malmö Malmö
Sweden Karolinska Universitetssjukhuset Stockholm
Sweden Norrlands Universitetssjukhus, Umea Umea
Sweden Akademiska Sjukhuset Uppsala
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City Kaohsiung
Taiwan China Medical University Hospital Taichung
Taiwan Taichung Veterans General Hospital Taichung
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei Veterans General Hospital Taipei
Taiwan Chang Gung Memorial Hospital at Linkou Taoyuan
Turkey Gazi Universitesi Tip Fakultesi Ankara
Turkey TC Saglik Bakanligi Goztepe ProfDr Suleyman Yalcin Sehir Has Istanbul
Ukraine Bukovinian State Medical University Chernivtsi
Ukraine City Dnipropetrovsk Multi- field Clinical Hosp. 4 DSMA Dnipro
Ukraine Kharkiv regional Clinical Centre of urology and nephrology Kharkiv
Ukraine Academy of Medical Science of Ukraine Kyiv
Ukraine Kyiv City Hospital #3 Kyiv
Ukraine Transkarpathian Regional Oncology Center Uzhgorod
United Kingdom Clatterbridge Centre for Oncology Bebington Merseyside
United Kingdom University Hospital of Wales Cardiff
United Kingdom Colchester General Hospital Colchester Essex
United Kingdom Russells Hall Hospital Dudley West Midlands
United Kingdom Beatson West of Scotland Cancer Centre Glasgow
United Kingdom Huddersfield Royal Infirmary Huddersfield West Yorkshire
United Kingdom Prince Philip Hospital Llanelli Carmarthenshire
United Kingdom Charing Cross Hospital London
United Kingdom University College London Hospitals NHS Foundation Trust London
United Kingdom Royal Berkshire Hospital Reading Berkshire
United Kingdom Scunthorpe General Hospital Scunthorpe North East Lincolnshire
United Kingdom Pinderfields Hospital The Mid Yorkshire Hospitals NHS Trust Wakefield West Yorkshire
United States New Mexico Oncology Hematology Consultants, Ltd. Albuquerque New Mexico
United States Anne Arundel Health System Annapolis Maryland
United States VA Eastern Colorado Health Care System Aurora Colorado
United States Centers for Advanced Urology, LLC Bala-Cynwyd Pennsylvania
United States Chesapeake Urology Associates Baltimore Maryland
United States Johns Hopkins Hospital/Health System Baltimore Maryland
United States St. Vincent Hospital & Healthcare Billings Montana
United States Boca Raton Regional Hospital Boca Raton Florida
United States Massachusetts General Hospital Boston Massachusetts
United States Montefiore Medical Center Bronx New York
United States New York Cancer & Blood Specialists Bronx New York
United States Andrews & Patel Associates Camp Hill Pennsylvania
United States Gabrail Cancer Center Canton Ohio
United States Ironwood Physicians P.C. DBA Ironwood Cancer & Res. Ctr. Chandler Arizona
United States Charleston Oncology Charleston South Carolina
United States Jesse Brown VA Medical Center Chicago Illinois
United States The Urology Group Cincinnati Ohio
United States Ohio State University Columbus Ohio
United States Urology Clinics of North Texas Dallas Texas
United States The Urology Center Of Colorado Denver Colorado
United States Henry Ford Health System Detroit Michigan
United States City of Hope National Medical Center Duarte California
United States Providence Regional Cancer Partnership Everett Washington
United States Inova Fairfax Hospital - Falls Church Falls Church Virginia
United States Bon Secours St. Francis Hospital Greenville South Carolina
United States Urology Centers of Alabama, PC Homewood Alabama
United States First Urology PSC Jeffersonville Indiana
United States San Diego Clinical Trials La Mesa California
United States Tower Urology, Inc Los Angeles California
United States VA Greater Los Angeles Healthcare System Los Angeles California
United States Norton Healthcare Pavilion Louisville Kentucky
United States Carolina Urological Research Center Myrtle Beach South Carolina
United States Urology Associates, PC Nashville Tennessee
United States GU Research Network, LLC Omaha Nebraska
United States Urology Cancer Center, PC Omaha Nebraska
United States Advent Health Medical Group Urology Orlando Florida
United States Illinois CancerCare, PC Peoria Illinois
United States Virginia Commonwealth University Richmond Virginia
United States University of Rochester Medical Center Rochester New York
United States TidalHealth Peninsula Regional, Inc. Salisbury Maryland
United States Huntsman Cancer Institute Salt Lake City Utah
United States Stanford Health Care Stanford California
United States Associated Medical Professionals of NY, PLLC Syracuse New York
United States New Jersey Urology, LLC Voorhees New Jersey
United States TOI Clinical Research Whittier California

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belarus,  Belgium,  Brazil,  Bulgaria,  Canada,  China,  Colombia,  Czechia,  Estonia,  Finland,  France,  Germany,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Mexico,  Netherlands,  Peru,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Sweden,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of treatment-emergent adverse events (TEAEs) Up to 4 years
Primary Incidence of treatment-emergent serious adverse events (TESAEs) Up to 4 years
Primary Incidence of drug-related TEAEs Up to 4 years
Primary Incidence of drug-related TESAEs Up to 4 years
Secondary Number of dose modifications Up to 4 years
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