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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04464226
• Other study ID #: 20321
• Secondary ID: 2019-003618-15
• Status: Recruiting
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Cancer

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

External Links

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