account_circleRecruiting

Cancer

Bayer Identifier:

20321

ClinicalTrials.gov Identifier:

NCT04464226

EudraCT Number:

2019-003618-15

EU CT Number:

2022-502084-38-00
Study to continue treatment with darolutamide in patients who have been participating in previous darolutamide studies supported by Bayer

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

18 - N/A
  • - 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.

  • - 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.

Trial summary

Enrollment Goal
402
Trial Dates
October 2020 - June 2028
Phase
Phase 3
Could I Receive a placebo
No
Products
Nubeqa (Darolutamide, BAY1841788)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Oncomédica S.A.Montería, 230002, Colombia
Completed
Hospital Pablo Tobón UribeMedellin, 050034, Colombia
Completed
Fundación Oftalmológica de Santander Carlos Ardila LuleFlorida Blanca, 681004, Colombia
Active, not recruiting
Centro Médico Monte Carmelo - Oncology DepartmentLa Victoria, 4001, Peru
Active, not recruiting
Instituto Peruano de Oncología & Radioterapia - Oncologia SA - Oncology DepartmentLIMA, TBC, Peru
Completed
Hospital Central de la Fuerza Aerea del PerúLima, 15046, Peru
Completed
CIUSSS de l’Estrie- Centre Haute-YamaskaGranby, J2G 1T7, Canada
Completed
Nova Scotia Health AuthorityHalifax, B3H 2Y9, Canada
Completed
Sunnybrook Health Sciences CentreToronto, M4N 3M5, Canada
Withdrawn
KINGSTON HEALTH SCIENCES CENTREKingston, K7L 3J7, Canada
Completed
London Health Sciences CentreLondon, N5R 6M6, Canada
Completed
Princess Margaret Hospital-University Health NetworkToronto, M5G 2M9, Canada
Completed
G. Kenneth Jansz Medicine Professional CorporationBurlington, L7N 3V2, Canada
Completed
Prostate Cancer CentreCalgary, T2V 1P9, Canada
Recruiting
Vilnius University Hospital Santaros KlinikosVilnius, LT-08661, Lithuania
Recruiting
National Cancer InstituteVilnius, LT-08660, Lithuania
Recruiting
Hospital of LT University of Health Sciences Kaunas ClinicsKaunas, LT-50161, Lithuania
Recruiting
P. Stradins Clinical University HospitalRiga, LV-1002, Latvia
Recruiting
Riga East Clinical University Hospital "Gailezers"Riga, LV-1038, Latvia
Completed
Gazi Universitesi Tip FakultesiAnkara, 6560, Turkey
Withdrawn
TC Saglik Bakanligi Goztepe ProfDr Suleyman Yalcin Sehir HasISTANBUL, 34724, Turkey
Completed
Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiung City, 807377, Taiwan
Active, not recruiting
National Taiwan University HospitalTaipei, 100, Taiwan
Active, not recruiting
Taichung Veterans General HospitalTaichung, 40705, Taiwan
Active, not recruiting
Chang Gung Memorial Hospital at LinkouTaoyuan, 33305, Taiwan
Completed
Gustave Roussy - Departement Oncologie-RadiotherapieVILLEJUIF CEDEX, 94805, France
Completed
Centre Hospitalier Universitaire - AngersAngers, 49933, France
Completed
Hôpital Saint LouisPARIS, 75010, France
Active, not recruiting
Institut de Cancerologie Jean GodinotReims, 51726, France
Completed
Hopital Hotel Dieu - NantesNANTES, 44000, France
Completed
Hôpital de la MilétriePOITIERS, 86021, France
Completed
Hopital BretonneauTours, 37044, France
Completed
Centre Médico-Chirurgical FochSURESNES, 92151, France
Completed
Hôpital Charles NicolleRouen, 76031, France
Completed
Centre Jean PerrinCLERMONT-FERRAND, 63011, France
Withdrawn
Centre d'Oncologie de GentillyNANCY, 54100, France
Completed
HCL - Centre Hospitalier Lyon SudPIERRE BENITE, 69495, France
Completed
CHU Rennes - Hopital PontchaillouRENNES CEDEX, 35033, France
Completed
Centre d'Oncologie et de Radiologie du ParcDIJON, 21000, France
Completed
Hôpital d'Instruction des Armées BeginSAINT MANDE, 94160, France
Completed
Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicaleBordeaux, 33000, France
Completed
Azienda Ospedaliero Universitaria ParmaParma, 43126, Italy
Completed
IRCCS Istituto Nazionale Tumori Fondazione Pascalenapoli, 80131, Italy
Active, not recruiting
Moscow Scient. Res. Institute of Oncology n.a P.A. HertzenMoscow, 125284, Russia
Active, not recruiting
Saratov State Medical UniversitySaratov, 410054, Russia
Completed
LLC ReafanNovosibirsk, 630099, Russia
Withdrawn
City clinical hospital #40 MoscowMoscow, 129301, Russian Federation
Active, not recruiting
Clinical Oncological Dispensary of Omsk RegionOmsk, 644013, Russia
Completed
Multi-Field Clinical Medical Center "Medical City"Tyumen, 625041, Russia
Completed
National Medical Research Radiology CenterObninsk, 249036, Russia
Completed
City Outpatient Clinic #1 of Privolzhsky Regional Med. Cent.Nizhny Novgorod, 603001, Russia
Withdrawn
St. Petersburg Medical University n.a. I.P. PavlovSt. Petersburg, 197022, Russian Federation
Active, not recruiting
Ivanovo Regional Oncology DispensaryIvanovo, 153040, Russia
Completed
Republican Clinical Oncology Dispensary KazanKazan, 420029, Russia
Withdrawn
Rostov State Medical UniversityRostov-on-Don, 344022, Russian Federation
Active, not recruiting
Regional Clinical Oncology DispensaryVladimir, 600009, Russia
Withdrawn
St. Petersburg Clinical Hospital of RASSt. Petersburg, 194017, Russia
Active, not recruiting
Leningrad Regional Oncology DispensarySt. Petersburg, 188663, Russia
Completed
Minsk City Clinical Oncological Dispensary - Oncology DepartmentMinsk, 220013, Belarus
Active, not recruiting
N.N. Alexandrov National Cancer Centre of Belarus - Oncology DepartmentLesnoy, 223040, Belarus
Completed
Adelaide Cancer Centre Research Pty LtdKurralta Park, 5037, Australia
Completed
Tampereen yliopistollinen sairaalaTampere, 33520, Finland
Completed
HUS, Meilahden sairaalaHelsinki, 00029, Finland
Withdrawn
Turun yliopistollinen keskussairaalaTurku, 20520, Finland
Completed
Seinäjoen keskussairaalaSeinäjoki, 60220, Finland
Active, not recruiting
Regional Medical Clinical Center of Urology and Nephrology n.a. V. I. Shapoval - Department of Oncologic Urology #5Kharkiv, 61037, Ukraine
Recruiting
Municipal Non-commercial Enterprise 'City Clinical Hospital #4' of Dnipro City Council - City ?hemotherapy ?enterDnipro, 49102, Ukraine
Active, not recruiting
Regional communal non-profit enterprise 'Chernivtsi regional clinical hospital' - Urological departmentChernivtsi, 58001, Ukraine
Active, not recruiting
Kyiv City Hospital #3 - Department of UrologyKyiv, 02660, Ukraine
Active, not recruiting
Transkarpathian Regional Oncology CenterUzhgorod, 88014, Ukraine
Active, not recruiting
SE "Academician O.F. Vozianov Institute of Urology" of NAMSU - Division of Reconstructive Urology and Advanced TechnologiesKyiv, 4053, Ukraine
Completed
Ciutat Sanitaria i Universitaria de la Vall d'HebronBarcelona, 08035, Spain
Completed
H Virgen del Rocio |Cardiology|AF|Stroke preventionSevilla, 41013, Spain
Completed
Instituto Valenciano de OncologíaValencia, 46009, Spain
Completed
Hospital Universitario Virgen de la Victoria | OncologyMálaga, 29010, Spain
Completed
Hospital General Universitario Gregorio Maranon | OncologiaMadrid, 28009, Spain
Completed
Hospital Universitario 12 de OctubreMadrid, 28041, Spain
Completed
Hospital de ManacorManacor, 7500, Spain
Completed
Hospital Lucus AugustíLugo, 27003, Spain
Completed
Hospital Universitari Son EspasesPalma De Mallorca, 7120, Spain
Completed
Hospital Arnau de Vilanova de ValenciaValencia, 46015, Spain
Completed
Hospital Clinico Universitario San Carlos | OncologiaMadrid, 28040, Spain
Completed
Fundacion Jimenez Diaz (Clinica de la Concepcion)Madrid, 28040, Spain
Withdrawn
Hospital Clínico de SalamancaSalamanca, 37007, Spain
Completed
Hospital Universitari de Bellvitge (HUB)Barcelona, 8908, Spain
Withdrawn
Hospital SAS de Jerez de la FronteraJerez de la Frontera, 11407, Spain
Completed
Hospital General de ElcheElche, 3203, Spain
Completed
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCSTorino, 10060, Italy
Completed
AZ Groeninge Campus KennedylaanKortrijk, 8500, Belgium
Completed
CHU de LiègeLIEGE, 4000, Belgium
Completed
Medical Center KalimatSofia, 1680, Bulgaria
Withdrawn
Privatna urologicka ambulancia, s.r.o.Trencin, 91101, Slovakia
Completed
CUIMED s.r.oBratislava, 85101, Slovakia
Completed
J. BREZA MEDICAL s. r. o.Bratislava, 851 01, Slovakia
Completed
Sihtasutus Põhja-Eesti Regionaalhaigla - Onkoloogia- ja hematoloogiakliinikTallinn, 13419, Estonia
Completed
Hospital Clínic i Provincial de BarcelonaBarcelona, 8036, Spain
Completed
Fundación Hospital AlcorcónAlcorcón, 28922, Spain
Completed
The Urology Center Of ColoradoDenver, 80211, United States
Completed
San Diego Clinical TrialsLa Mesa, 91942, United States
Completed
Gabrail Cancer CenterCanton, 44718, United States
Withdrawn
Associated Medical Professionals of NY, PLLCSyracuse, 13210, United States
Completed
Tower Urology, IncLos Angeles, 90048, United States
Withdrawn
Debreceni Egyetem Klinikai KozpontDebrecen, 4032, Hungary
Active, not recruiting
Zala Varmegyei Szent Rafael KorhazZalaegerszeg, 8900, Hungary
Completed
Urologica Praktyka Lekarska Adam MarchelukSiedlce, 08-110, Poland
Withdrawn
EMC Instytut Medyczny SAWroclaw, 54-144, Poland
Completed
Associação Hospitalar Beneficente São Vicente de PauloPasso Fundo, 99010-080, Brazil
Active, not recruiting
IBCC - Instituto Brasileiro de Controle do CancerSão Paulo, 03102-002, Brazil
Completed
Instituto do Cancer do CearáFortaleza, 60441-700, Brazil
Completed
Clínica de Neoplasias Litoral LtdaItajaí, 88301-220, Brazil
Active, not recruiting
Instituto do Cancer do Estado de Sao PauloSão Paulo, 01246-000, Brazil
Active, not recruiting
Hosp. Araujo Jorge da Associação de Combate ao CâncerGoiânia, 74605-070, Brazil
Withdrawn
Inst. de Assistência Médica ao Sérvidor Público EstadualSão Paulo, 04039-004, Brazil
Active, not recruiting
Irmandade Santa Casa de Misericordia de Porto Alegre | OncologyPorto Alegre, 90020-090, Brazil
Active, not recruiting
Hosp Clínicas Facult. Med. de Ribeirão Preto / USPRibeirão Preto, 14051-140, Brazil
Active, not recruiting
Liga Paranaense de Combate ao Cancer-Hosp Erasto GaertnerCuritiba, 81520-060, Brazil
Withdrawn
IEP São LucasSão Paulo, 01234-030, Brazil
Active, not recruiting
Fundacao Pio XII – Hospital de Cancer de BarretosBarretos/SP, 14784-400, Brazil
Active, not recruiting
Santa Casa de Misericórdia da BahiaSalvador, 50040-410, Brazil
Active, not recruiting
COT Centro Oncologico do Triangulo LtdaUberlandia, 38408-150, Brazil
Completed
IPO PortoPorto, 4200-072, Portugal
Withdrawn
ULSM - Hospital Pedro HispanoMatosinhos, 4464-513, Portugal
Completed
Cancercare OuteniquaGeorge, 6530, South Africa
Active, not recruiting
Cancercare Rondebosch OncologyRondebosch, 7700, South Africa
Completed
Hospital Amaral CarvalhoJaú, 17210-120, Brazil
Active, not recruiting
União Bras. de Edu. e Assist. Hospital São Lucas da PUCRSPorto Alegre, 90619900, Brazil
Active, not recruiting
Gangnam Severance Hospital, Yonsei University Health SystemSeoul, 6273, Korea,_republic_of
Active, not recruiting
Chungbuk National University HospitalCheongju-si, 28644, Korea,_republic_of
Active, not recruiting
Samsung Medical CenterSeoul, 06351, Korea,_republic_of
Active, not recruiting
Seoul National University HospitalSeoul, 3080, Korea,_republic_of
Active, not recruiting
Chonnam National University HospitalGwangju, 501-757, Korea,_republic_of
Active, not recruiting
Asan Medical CenterSeoul, 05505, Korea,_republic_of
Active, not recruiting
The Catholic University of Korea Seoul St. Mary's HospitalSeoul, 137-701, Korea,_republic_of
Active, not recruiting
Gachon University Gil Medical CenterIncheon, 21565, Korea,_republic_of
Active, not recruiting
Kyungpook National University Chilgok HospitalDaegu, 700721, Korea,_republic_of
Completed
Keimyung University Dongsan Medical CenterDaegu, 42601, Korea,_republic_of
Active, not recruiting
ETG Network Spolka z o.o.Lodz, 90-302, Poland
Active, not recruiting
Europejskie Centrum Zdrowia Otwock, Szpital im. F. ChopinaOtwock, 05-400, Poland
Completed
XCancer OmahaOmaha, 68130, United States
Withdrawn
First Urology PSCJeffersonville, 47130, United States
Completed
Chesapeake Urology Associates - TowsonBaltimore, 21204, United States
Completed
Urology Associates, PCNashville, 37209, United States
Completed
The Urology GroupCincinnati, 45212, United States
Completed
Jesse Brown VA Medical Center - CardiologyChicago, 60612, United States
Completed
New Jersey Urology, LLCVoorhees, 08043, United States
Active, not recruiting
Montefiore Einstein Center for Cancer CareBronx, 14061, United States
Completed
TOI Clinical ResearchWhittier, 90603, United States
Completed
Dudley Group NHS Foundation Trust ¦Russells Hall Hopsital - OncologyDudley, DY1 2HQ, United Kingdom
Completed
University Hospital of WalesCardiff, CF14 4XW, United Kingdom
Completed
Calderdale and Huddersfield NHS Foundation Trust¦Huddersfield Royal Infirmary - OncologyHuddersfield, HD3 3EA, United Kingdom
Completed
Mid Yorkshire Teaching NHS Trust¦Pinderfields Hospital - OncologyWakefield, WF1 4DG, United Kingdom
Completed
Clatterbridge Centre for OncologyBebington, CH63 4JY, United Kingdom
Completed
Scunthorpe General HospitalScunthorpe, DN15 7BH, United Kingdom
Completed
Prince Philip HospitalLlanelli, SA14 8QF, United Kingdom
Completed
Royal Berkshire NHS Foundation Trust¦Royal Berkshire Hospital - OncologyReading, RG1 5AN, United Kingdom
Completed
Beatson West of Scotland Cancer CentreGlasgow, G12 0YN, United Kingdom
Active, not recruiting
Szpital Grochowski im. dr.med. Rafala MasztakaWarszawa, 04-073, Poland
Completed
Universitätsmedizin der Johannes Gutenberg Universität MainzMainz, 55101, Germany
Withdrawn
Gesundheitszentrum HolzmindenHolzminden, 37603, Germany
Completed
Universitaetsklinikum MuensterMünster, 48149, Germany
Completed
Uniklinik Tübingen / UrologieTübingen, 72076, Germany
Completed
Uro-Gyn-Zentrum Wall Hr. Dr. Jochen GleißnerWuppertal, 42103, Germany
Withdrawn
Urologische GemPraxis Dr. R. RudolphKirchheim unter Teck, 73230, Germany
Completed
Urologische Gemeinschaftspraxis Dr. Simone MaierReutlingen, 72764, Germany
Completed
Heinrich-Heine-Universität DüsseldorfDüsseldorf, 40225, Germany
Completed
Medizinische Fakultät der Otto-von-Guericke UniversitätMagdeburg, 39120, Germany
Withdrawn
Universitätsklinikum der Johann Wolfgang Goethe UniversitätFrankfurt, 60590, Germany
Completed
Studienpraxis UrologieNürtingen, 72622, Germany
Completed
Praxis Drs. Tim Schneider /B. SchneiderMühlheim, 45468, Germany
Completed
VA Eastern Colorado Health Care SystemAurora, 80045, United States
Active, not recruiting
ANDROGEOS, spol. s r.o.Praha 6, 160 00, Czech Republic
Active, not recruiting
Všeobecná fakultní nemocnice v PrazePraha 2, 12808, Czech Republic
Active, not recruiting
Urocentrum Praha, s.r.o.Praha 2, 120 00, Czech Republic
Completed
Nemocnice Jablonec nad NisouJablonec nad Nisou, 46601, Czech Republic
Completed
Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao ClinicaLisboa, 1500-650, Portugal
Completed
Centro Hospitalar Universitario de Sao Joao | Polo Porto - Centro de Investigacao e Ensaios ClinicosPorto, 4200-319, Portugal
Completed
IPO LisboaLisboa, 1093 CODEX, Portugal
Completed
CHLC - Hospital Sao JoseLisboa, 1150-199, Portugal
Completed
Universitätsklinikum AKH WienWien, 1090, Austria
Completed
Hospital Garcia de Orta | Research DepartmentAlmada, 2805-267, Portugal
Withdrawn
Uniwersyteckie Centrum KliniczneGdansk, 80-214, Poland
Withdrawn
Anne Arundel Health SystemAnnapolis, 21401, United States
Completed
Urology Centers of Alabama, PCHomewood, 35209, United States
Completed
New York Cancer & Blood SpecialistsBronx, 10469, United States
Completed
TidalHealth Peninsula Regional, Inc.Salisbury, 21801, United States
Withdrawn
Advent Health Medical Group UrologyOrlando, 32803, United States
Withdrawn
Massachusetts General HospitalBoston, 02114-2696, United States
Completed
MidLantic Urology - Bala CynwydBala Cynwyd, 19004, United States
Completed
Karolinska UniversitetssjukhusetStockholm, 171 76, Sweden
Completed
Sahlgrenska UniversitetssjukhusetGöteborg, 413 45, Sweden
Completed
Akademiska SjukhusetUppsala, TBC, Sweden
Active, not recruiting
Dept Radiation and Oncology Tygerberg Academic HospitalCape Town, 7505, South Africa
Completed
Centro de UrologíaBuenos Aires, C1120AAT, Argentina
Completed
Krasnoyarsk Regional Clinical Oncology DispensaryKrasnoyarsk, 660133, Russia
Active, not recruiting
Sapporo Medical University HospitalSapporo, 060-8543, Japan
Active, not recruiting
Gunma University HospitalMaebashi, 371-8511, Japan
Active, not recruiting
Saiseikai Utsunomiya HospitalUtsunomiya, 321-0974, Japan
Active, not recruiting
Kitasato University HospitalSagamihara, 252-0375, Japan
Completed
Yokosuka Kyosai HospitalYokosuka, 238-8558, Japan
Completed
Institutul Clinic FundeniBucuresti, 22328, Romania
Active, not recruiting
Spitalul Clinic Judetean MuresTargu-Mures, 540103, Romania
Withdrawn
Spitalul Clinic Judetean de Urgenta OradeaOradea, 410159, Romania
Withdrawn
Sf. Nectarie Oncology CenterCraiova, 200542, Romania
Active, not recruiting
Yokohama City University Medical CenterYokohama, 232-0024, Japan
Completed
Kyorin University HospitalMitaka, 181-8611, Japan
Completed
Tokyo Metropolitan Institute for Geriatrics and GerontologyItabashi-ku, 173-0015, Japan
Active, not recruiting
Tokyo Metropolitan Police HospitalNakano-ku, 164-8541, Japan
Active, not recruiting
The Fraternity Memorial HospitalSumida-ku, 130-8587, Japan
Completed
Nippon Medical School HospitalBunkyo-Ku, 113-0022, Japan
Active, not recruiting
Juntendo University HospitalBunkyo-ku, 113-8431, Japan
Completed
Toyama University HospitalToyama, 930-0194, Japan
Completed
National Hospital Organization Shinshu Ueda Medical CenterUeda, 386-8610, Japan
Active, not recruiting
Hamamatsu University HospitalHamamatsu, 431-3192, Japan
Active, not recruiting
Osaka International Cancer InstituteOsaka-shi, 541-8567, Japan
Completed
Osaka General Medical CenterOsaka, 558-8558, Japan
Withdrawn
Osaka Metropolitan University HospitalOsaka, 545-8586, Japan
Completed
Hiroshima City Hiroshima Citizens HospitalHiroshima, 730-8518, Japan
Active, not recruiting
Yamaguchi University HospitalUbe, 755-8505, Japan
Active, not recruiting
Oita University HospitalYufu, 879-5593, Japan
Withdrawn
National Cancer Center Hospital EastKashiwa, 277-8577, Japan
Active, not recruiting
National hospital Organization Mito Medical CenterHigashiibaraki, 311-3193, Japan
Active, not recruiting
Kindai University HospitalSayama, 589-8511, Japan
Completed
Urologische Gemeinschaftspraxis MuehlackerMuehlacker, 75417, Germany
Completed
Urologische Gemeinschaftspraxis Carl-Andreas-MeilingerEmmendingen, 79312, Germany
Active, not recruiting
Tolna Varmegyei Balassa Janos KorhazSzekszard, 7100, Hungary
Completed
Clinical Hospital Center Bezanijska kosaBelgrade, 11080, Serbia
Active, not recruiting
Clinical Center NisNis, 18000, Serbia
Active, not recruiting
Spaarne GasthuisHoofddorp, 2134 TM, Netherlands
Withdrawn
Nederlands Kanker InstituutAmsterdam, 1066 CX, Netherlands
Active, not recruiting
ETZ TweeSteden Ziekenhuis (vh Maria Ziekenhuis)Tilburg, 5042 AD, Netherlands
Active, not recruiting
Academisch Medisch Centrum (AMC)AMSTERDAM, 1105 AZ, Netherlands
Active, not recruiting
Zuyderland Medical Centre | Internal Medicine DepartmentGeleen, 6162 BG, Netherlands
Completed
Tergooi MC | Hilversum - WetenschapsbureauHilversum, 1213 VG, Netherlands
Active, not recruiting
HagaZiekenhuisDEN HAAG, 2545 CH, Netherlands
Active, not recruiting
Albert Schweitzer Ziekenhuis | Dordwijk - Cardiology DepartmentDORDRECHT, 3318 AT, Netherlands
Completed
Friedrich-Schiller-Uni. JenaJena, 07747, Germany
Completed
Universitätsklinikum ErlangenErlangen, 91054, Germany
Completed
Städtisches Klinikum Braunschweig gGmbHBraunschweig, 38126, Germany
Withdrawn
Universitätsklinikum UlmUlm, 89075, Germany
Completed
Universitätsklinikum FreiburgFreiburg, 79106, Germany
Active, not recruiting
Hospital Universitario "José Eleuterio González"Monterrey, TBC, Mexico
Completed
INBIOMEDyC QuerétaroSantiago de Querétaro, 76000, Mexico
Withdrawn
Mazowiecki Szpital OnkologicznyWaliszew, 05-135, Poland
Completed
Hospital del MarBarcelona, 08003, Spain
Completed
Hospital Ramón y Cajal | OncologíaMadrid, 28034, Spain
Completed
Hospital de la Santa Creu i de Sant Pau | OncologíaBarcelona, 8041, Spain
Completed
Norrlands Universitetssjukhus, UmeaUmea, 901 85, Sweden
Withdrawn
Skånes Universitetssjukhus MalmöMalmö, 205 02, Sweden
Completed
Corporació Sanitària Parc TaulíSabadell, 08208, Spain
Completed
Centre Hospitalier de l'Universite de Montreal (CHUM) - HopiMontreal, H2X 3E4, Canada
Recruiting
Huadong Hospital, Affiliated to Fudan UniversityShanghai, 200040, China
Recruiting
ZheJiang Provincial People's HospitalHangzhou, 310014, China
Recruiting
Hunan Cancer HospitalChangsha, 410013, China
Recruiting
Hubei Cancer HospitalWuhan, 430079, China
Recruiting
Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.Wuhan, 430030, China
Completed
Complex Oncology Center - VratsaVratsa, 3000, Bulgaria
Recruiting
Beijing HospitalBeijing, 100730, China
Recruiting
Liaoning Cancer Hospital and InstituteShengyang, 110042, China
Completed
Oulun yliopistollinen sairaalaOulu, 90220, Finland
Completed
Turun yliopistollinen keskussairaalaTurku, 20520, Finland
Completed
Mikkelin keskussairaalaMikkeli, FIN-50100, Finland
Completed
Keski-Suomen sairaala NovaJyväskylä, 40620, Finland
Recruiting
Fudan University Shanghai Cancer CenterShanghai, 200000, China
Recruiting
Jiangsu Cancer HospitalNanjing, 210000, China
Recruiting
The First Affiliated Hospital of Xi'an Jiaotong UniversityXi'an, 710061, China
Recruiting
Anhui Provincial HospitalHefei City, Anhui Province, 230031, China
Recruiting
The First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, 325000, China
Recruiting
Beijing Cancer HospitalBeijing, 100142, China
Completed
Chongqing Cancer HospitalChongqing, 400030, China
Active, not recruiting
Beijing Cancer HospitalBeijing, 100142, China
Recruiting
Tianjin Medical University Cancer Institute & HospitalTianjin, 300000, China
Recruiting
Qilu Hosp., Shandong Univ.Jinan, 250000, China
Active, not recruiting
KO-MED Centra Kliniczne Lublin IILublin, 20-362, Poland
Withdrawn
SPZOZ Wojewodzki Szpital Specjalistyczny nr 3Rybnik, 44-200, Poland
Withdrawn
Centrum Onkologii - Instytut im. M.Sklodowskiej-CurieWarszawa, 02-781, Poland
Completed
Hospital Reina SofíaCórdoba, 14004, Spain
Active, not recruiting
Russian Oncological Scientific Center n.a. N.N. Blokhin RAMSMoscow, 115478, Russia
Active, not recruiting
Hospital São RafaelSalvador, 41253-190, Brazil
Active, not recruiting
Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa ClínicaNatal, 59040-000, Brazil
Completed
Hospital Evangélico de Cachoeiro de ItapemirimCachoeiro de Itapemirim, 29308-020, Brazil
Active, not recruiting
Taipei Veterans General HospitalTaipei, 11217, Taiwan
Active, not recruiting
China Medical University HospitalTaichung, 404327, Taiwan
Active, not recruiting
Fakultni nemocnice Kralovske VinohradyPraha 10, 10034, Czech Republic
Withdrawn
CU Saint-Luc/UZ St-LucBRUXELLES - BRUSSEL, 1200, Belgium
Withdrawn
UZ GentGENT, 9000, Belgium
Completed
GZA ZiekenhuizenWilrijk, 2610, Belgium
Withdrawn
CHU UCL NamurNamur, 5000, Belgium
Completed
Zhongshan Hospital, Fudan UniversityShanghai, 200032, China
Active, not recruiting
Masarykuv onkologicky ustavBrno, 65653, Czech Republic
Active, not recruiting
Rabin Medical Center | Beilinson Hospital - Internal Medicine C DepartmentPetach Tikva, 4941492, Israel
Active, not recruiting
Clalit Health | Soroka Medical Center - Internal Medicine DepartmentBeer Sheva, 8410101, Israel
Active, not recruiting
Health Corporation of the Ziv Medical Center (R.A.)Zefat, 1311001, Israel
Recruiting
The First Affiliated Hospital of Xiamen UniversityXiamen, 361003, China
Withdrawn
Inje University Busan Paik HospitalBusan, 47392, Korea, Republic Of
Active, not recruiting
Severance Hospital, Yonsei University Health SystemSeoul, 03722, Korea,_republic_of
Withdrawn
Seoul National Univ. Bundang HospitalSeongnam-si, 13620, Korea, Republic Of
Completed
Institut de Cancerologie Ouest - Saint-HerblainSaint-Herblain, 44800, France
Completed
HCL - Centre Hospitalier Lyon SudPIERRE BENITE, 69495, France
Completed
Institut Paoli-Calmettes - MarseilleMARSEILLE, 13273, France
Completed
Clinique LanrozeBREST, 29200, France
Active, not recruiting
Chelyabinsk Regional Oncology DispensaryChelyabinsk, 454087, Russia
Active, not recruiting
Ltd "EVIMED"Chelyabinsk, 454048, Russia
Active, not recruiting
Medical Center "Avicenna"Novosibirsk, 630099, Russia
Completed
St. Vincent Hospital & HealthcareBillings, 59102, United States
Completed
Stanford Health CareStanford, 94305, United States
Completed
Huntsman Cancer Institute- Salt Lake CitySalt Lake City, 84112, United States
Withdrawn
VA Greater Los Angeles Healthcare SystemLos Angeles, 90073-1003, United States
Completed
Providence Regional Cancer PartnershipEverett, 98201, United States
Completed
New Mexico Oncology Hematology Consultants, Ltd.Albuquerque, 87109, United States
Withdrawn
City of Hope National Medical CenterDurate, 91010, United States
Completed
Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Oncologia MedicaOrbassano, 10043, Italy
Completed
Istituto Oncologico Veneto_Padova - UOC Oncologia 1Padova, 35128, Italy
Completed
Illinois CancerCare - PeoriaPeoria, 61615, United States
Completed
University of Rochester Medical CenterRochester, 14642, United States
Completed
Henry Ford Hospital - OB/GYNDetroit, 48202, United States
Completed
Johns Hopkins Hospital - PulmonologyBaltimore, 21287, United States
Completed
University College London Hospitals NHS Foundation TrustLondon, NW1 2PG, United Kingdom
Completed
East Suffolk and North Essex NHS Foundation Trust¦Colchester General Hospital - Oncology Trials UnitColchester, CO45JR, United Kingdom
Completed
Charing Cross HospitalLondon, W6 8RF, United Kingdom
Completed
Cross Cancer InstituteEdmonton, T6G 1Z2, Canada
Completed
Norton Cancer Institute - DowntownLouisville, 40202, United States
Completed
Andrews & Patel AssociatesCamp Hill, 17011, United States
Withdrawn
Bon Secours St. Francis HospitalGreenville, 29607, United States
Completed
Carolina Urological Research CenterMyrtle Beach, 29579, United States
Withdrawn
Urology Cancer Center, PCOmaha, 68130-5606, United States
Completed
Charleston Oncology - DowntownCharleston, 29403, United States
Completed
Hospital San Pedro de AlcántaraCáceres, 10003, Spain
Completed
Boca Raton Regional Hospital - OncologyBoca Raton, 33486, United States
Completed
Inova Schar Cancer Insitute - Inova Fairfax HospitalFairfax, 22031, United States
Completed
ICM - Institut du Cancer de Montpellier - Val d'AurelleMONTPELLIER CEDEX, 34298, France
Completed
Ironwood Cancer and Research Centers - Chandler IChandler, 85224, United States
Active, not recruiting
Urology Clinics of North TexasDallas, 75231, United States
Completed
Virginia Commonwealth UniversityRichmond, 23284, United States
Completed
Ohio State UniversityColumbus, 43210, United States
Active, not recruiting
Kobe University HospitalKobe, 650-0017, Japan
Active, not recruiting
National Hospital Organization Kumamoto Medical CenterKumamoto, 860-0008, Japan
Active, not recruiting
Toho University Sakura Medical CenterSakura, 285-8741, Japan
Completed
Tottori University HospitalYonago, 683-8504, Japan
Completed
The University of Osaka HospitalSuita, 565-0871, Japan
Active, not recruiting
Mie University HospitalTsu, 514-8507, Japan
Active, not recruiting
Wakayama Medical University HospitalWakayama, 640-8558, Japan
Active, not recruiting
Keio University HospitalShinjuku-ku, 160-8582, Japan
Active, not recruiting
Chiba Cancer CenterChiba, 260-8717, Japan
Active, not recruiting
Nagoya University HospitalNagoya, 466-8560, Japan
Active, not recruiting
University of Miyazaki HospitalMiyazaki, 889-1692, Japan
Active, not recruiting
Nagasaki University HospitalNagasaki, 852-8501, Japan
Active, not recruiting
Asahi General HospitalAsahi, 289-2511, Japan
Active, not recruiting
Gifu Prefectural General Medical CenterGifu, 500-8717, Japan
Recruiting
The Second Hospital of Tianjin Medical UniversityTianjin, 300211, China
Recruiting
ZheJiang Provincial People's HospitalZhejiang, 314408, China
Recruiting
The First Affiliated Hospital of Nanjing Medical Universitynanjing, 210029, China
Recruiting
The First Hospital of Jilin UniversityChangchun City, 130061, China
Recruiting
The First Affiliated Hospital of NanChang UniversityNanchang, 330006, China
Recruiting
Sichuan University West China HospitalChengdu, MISSING, China
Recruiting
Sun Yat-sen University Cancer CenterGuangzhou, 510000, China
Recruiting
Shanghai General HospitalShanghai, 200080, China
Withdrawn
Shanghai Tenth People's HospitalShanghai, 200072, China
Recruiting
Nantong tumor hospitalNantong, 226361, China
Recruiting
Shanxi Medical University - First HospitalTaiyuan, TBC, China
Active, not recruiting
Ruijin Hosp. Shanghai Jiaotong Univ.School of MedicineShanghai, 200025, China
Recruiting
University of Electronic Science & Technology of China - Sichuan Cancer Hospital & Institute (Sichuan Provincial Tumor Hospital)chengdu, 610041, China
Recruiting
The First Affiliated hospital of Fujian Medical UniversityFuzhou, 350005, China
Recruiting
The Second Hospital of Anhui medical universityHefei, 230601, China
Recruiting
2nd Affiliated Hosp. of Shantou University Medical CollegeShantou, 515021, China
Recruiting
The 2nd Affiliated Hospital of Soochow UniversitySuzhou, 215004, China
Withdrawn
Shengjing Hospital of China Medical UniversityShenyang, 110004, China
Recruiting
Peking University Third HospitalBeijing, 100083, China
Recruiting
The Affiliated Hospital of Qingdao Universityshandong, 266000, China
Recruiting
Ningbo First HospitalNingbo, 315010, China
Not yet recruiting
CNE "Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of the Cherkasy Regional Council"Cherkasy, 18009, Ukraine

Primary Outcome

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

Secondary Outcome

  • Number of dose modifications
    date_rangeTime Frame:
    Up to 4 years

Trial design

An open-label, single arm, roll-over study to provide continued treatment with darolutamide in participants who were enrolled in previous Bayer sponsored studies
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
N/A
Blinding
N/A
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.