A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide Plus Androgen Deprivation Therapy (ADT) Compared With Placebo Plus ADT in Patients With High-risk Biochemical Recurrence (BCR) of Prostate Cancer

Status: Recruiting
Location: See all (293) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Researchers are looking for a better way to treat men at high-risk of biochemical recurrence (BCR) of prostate cancer. BCR means that in men who had prostate cancer and were treated by either surgery and/ or radiation therapy, the blood level of a specific protein called PSA rises. PSA is a marker of prostate cancer cells activity. The PSA increase means that the cancer has come back even though conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans does not show any lesion of prostate cancer. Recently a more sensitive imaging method called prostate-specific membrane antigen \[PSMA\] positron emission tomography \[PET\]) /computed tomography \[CT\]) scan may identify prostate cancer lesions not detectable by conventional imaging. Men with BCR have a higher risk of their cancer spreading to other parts of the body, particularly when PSA levels raised to a certain limit within a short period of time after local therapies. Once the cancer spreads to other parts of the body, it can become even harder to treat. In men with prostate cancer, male sex hormones (also called androgens) like testosterone can help the cancer grow and spread. To reduce androgens levels in these patients, there are treatments that block androgens production in the body called androgen deprivation therapy (ADT). ADT is often used to stop prostate cancer. Another way to stop prostate cancer growth and spread is to block the action of androgen receptors on prostate cancer cells called androgen receptor inhibitors (ARIs). The new generation ARIs including darolutamide can block the action of androgens receptors and are available for the treatment of prostate cancer in addition to ADT. It is already known that men with prostate cancer benefit from these treatments. The main objective of this study is to learn if the combination of darolutamide and ADT prolongs the time that the participants live without their cancer getting worse, or to death due to any cause, compared to placebo (which is a treatment that looks like a medicine but does not have any medicine in it) and ADT given for a pre-specified duration of 24 months. To do this, the study team will measure the time from the date of treatment allocation to the finding of new cancer spread in the participants by using PSMA PET/CT, or death due to any cause. The PSMA PET/CT scans is performed using a radioactive substance called a tracer that specifically binds to the prostate-specific membrane antigen (PSMA) which is a protein often found in large amounts on prostate cancer cells. To avoid bias in treatment, the study participants will be randomly (by chance) allocated to one of two treatment groups. Based on the allocated treatment group, the participants will either take darolutamide plus ADT or placebo plus ADT twice daily as tablets by mouth. The study will consist of a test (screening) phase, a treatment phase and a follow-up phase. The treatment duration is pre-specified to be 24 months unless the cancer gets worse, the participants have medical problems, or they leave the study for any reason. In addition, image guided radiotherapy (IGRT) or surgery is allowed and your doctor will explain the benefits and risks of this type of therapy. During the study, the study team will: * take blood and urine samples. * measure PSA and testosterone levels in the blood samples * do physical examinations * check the participants' overall health * examine heart health using electrocardiogram (ECG) * check vital signs * check cancer status using PSMA PET/CT scans, CT, MRI and bone scans * take tumor samples (if required) * ask the participants if they have medical problems About 30 days after the participants have taken their last treatment, the study doctors and their team will check the participants' health and if their cancer worsened. The study team will continue to check this and regularly ask the participants questions about medical problems and subsequent therapies until they leave the study for any reason or until they leave the study for any reason or until the end of the study, whatever comes first.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Capable of giving signed informed consent as described which includes compliance with the requirements, restrictions listed in the informed consent form (ICF), and in this protocol.

• Male ≥18 years of age at the time of signing the informed consent.

• Histologically or cytologically confirmed adenocarcinoma of prostate.

• Prostate cancer initially treated by: radical prostatectomy (RP) followed by adjuvant radiotherapy (ART), or salvage radiotherapy (SRT), or RP in participants who are unfit for (or refused) ART or SRT, or primary radiotherapy (RT).

• High-risk biochemical recurrence (BCR), defined as Prostate-specific antigen doubling time (PSADT) \<12 months calculated using the formula provided by the Sponsor, and PSA ≥0.2 ng/mL after ART or SRT post RP or after RP in participants who are unfit for ART or SRT (local or central values accepted), or PSA ≥2 ng/mL above the nadir after primary RT only (local or central values accepted).

• Participants must undergo prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) within the 42-day Screening period using either 18F-DCFPyL (piflufolastat F 18) or 68Ga-PSMA-11 which will be assessed by blinded independent central review (BICR) to identify at least one PSMA PET/CT lesion of prostate cancer.

• Serum testosterone ≥150 ng/dL (5.2 nmol/L) (local assessment is allowed whenever central assessment cannot be done).

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Blood counts at screening: Hemoglobin ≥9.0 g/dL (participant must not have received blood transfusion within 7 days prior to sample being taken); Absolute neutrophil count (ANC) ≥1.5x10\^9/L (participant must not have received any growth factor within 4 weeks prior to sample being taken); Platelet count ≥100x10\^9/L.

• Screening values of: Alanine aminotransferase (ALT) ≤1.5 x upper limit of normal (ULN); Aspartate aminotransferase (AST) ≤1.5 x ULN; Total bilirubin (TBL) ≤1.5 ULN, (except participants with a diagnosis of Gilbert's disease); Estimated glomerular filtration rate (eGFR) \>40 ml/min/1.73 m\^2 calculated by the CKD-EPI formula.

• Sexually active male participants must agree to use contraception as detailed in the protocol during the Treatment period and for at least 1 week after the last dose of study treatment, and refrain from donating sperm during this period.

Locations
United States
Arizona
City of Hope - Phoenix Cancer Center
NOT_YET_RECRUITING
Goodyear
Mayo Clinic Hospital - Phoenix - Cardiology
RECRUITING
Phoenix
Arizona Institute of Urology
WITHDRAWN
Tucson
California
City of Hope - Duarte Cancer Center
ACTIVE_NOT_RECRUITING
Duarte
Tower Urology
TERMINATED
Los Angeles
UCLA Clark Urology Center
ACTIVE_NOT_RECRUITING
Los Angeles
USC Norris Comprehensive Cancer Center
RECRUITING
Los Angeles
University of California Irvine Medical Center
WITHDRAWN
Orange
UCSF Bakar Precision Cancer Medicine Building - Genitourinary
ACTIVE_NOT_RECRUITING
San Francisco
Colorado
Colorado Urology - St. Anthony Hospital Campus
ACTIVE_NOT_RECRUITING
Lakewood
Florida
Clermont Oncology Center
WITHDRAWN
Clermont
University of Florida - Jacksonville
WITHDRAWN
Jacksonville
Mid Florida Cancer Centers
WITHDRAWN
Orange City
Illinois
Comprehensive Cancer Center
WITHDRAWN
Chicago
Jesse Brown VA Medical Center
WITHDRAWN
Chicago
Northwestern Medicine - Urology
RECRUITING
Chicago
Indiana
Urology of Indiana, LLC
WITHDRAWN
Greenwood
First Urology PSC
WITHDRAWN
Jeffersonville
Kansas
The University of Kansas Cancer Center - Richard and Annette Bloch Radiation Oncology Pavilion
ACTIVE_NOT_RECRUITING
Kansas City
Massachusetts
Dana-Farber Cancer Institute - Oncology Department
COMPLETED
Boston
UMass Memorial Medical Center - University Campus
WITHDRAWN
Worcester
Maryland
Chesapeake Urology Associates - Towson
RECRUITING
Baltimore
Sidney Kimmel Comprehensive Cancer Center - Johns Hopkins
RECRUITING
Baltimore
Michigan
Barbara Ann Karmanos Cancer Institute - Detroit Headquarters
ACTIVE_NOT_RECRUITING
Detroit
Michigan Institute of Urology - Troy - Town Center Building
WITHDRAWN
Troy
Minnesota
M Health Fairview Masonic Cancer Clinic - Clinics and Surgery Center
RECRUITING
Minneapolis
Missouri
Washington University School of Medicine - Center for Advanced Medicine (CAM)
COMPLETED
St Louis
North Carolina
Alliance Urology Specialists
RECRUITING
Greensboro
Wake Forest Baptist Health
WITHDRAWN
Winston-salem
Nebraska
Urology Cancer Center, PC
RECRUITING
Omaha
New Jersey
New Jersey Urology (NJU)
WITHDRAWN
Saddle Brook
New Jersey Urology - Voorhees
WITHDRAWN
Voorhees Township
New York
NYU Langone Health
COMPLETED
Mineola
Icahn School of Medicine at Mount Sinai - Oncology
NOT_YET_RECRUITING
New York
Associated Medical Professionals of NY, PLLC
WITHDRAWN
Syracuse
White Plains Hospital
NOT_YET_RECRUITING
White Plains
Ohio
The Urology Group - Norwood Surgery Center
WITHDRAWN
Cincinnati
Ohio State University Wexner Medical Center
WITHDRAWN
Columbus
Pennsylvania
MidLantic Urology - Bala Cynwyd
WITHDRAWN
Bala-cynwyd
Urological Associates of Lancaster
WITHDRAWN
Lancaster
Allegheny General Hospital
RECRUITING
Pittsburgh
University of Pittsburgh
WITHDRAWN
Pittsburgh
VA Pittsburgh Healthcare System
WITHDRAWN
Pittsburgh
South Carolina
Bon Secours St. Francis Hospital
WITHDRAWN
Greenville
Carolina Urological Research Center
RECRUITING
Myrtle Beach
Texas
Urology Austin, PLLC (an affiliate of Urology America)
WITHDRAWN
Austin
University Hospital Simmons Cancer Center Genitourinary Clinic
RECRUITING
Dallas
The University of Texas MD Anderson Cancer Center - Texas Medical Center
ACTIVE_NOT_RECRUITING
Houston
The Urology Place
RECRUITING
San Antonio
Urology San Antonio, PA dba USA Clinical Trials
RECRUITING
San Antonio
Washington
Spokane Urology PS
WITHDRAWN
Spokane
Other Locations
Australia
Royal Adelaide Hospital
ACTIVE_NOT_RECRUITING
Adelaide
Blacktown Hospital
WITHDRAWN
Blacktown
Eastern Clinical Research Unit - Box Hill
RECRUITING
Box Hill
Royal Brisbane & Women's Hospital
NOT_YET_RECRUITING
Brisbane
Bundaberg Hospital, Genesis Cancer Care - Bundaberg
WITHDRAWN
Bundaberg
Chris O'Brien Lifehouse
RECRUITING
Camperdown
Epworth HealthCare
RECRUITING
East Melbourne
Northern Hospital
RECRUITING
Epping
Barwon Health
ACTIVE_NOT_RECRUITING
Geelong
Austin Health
ACTIVE_NOT_RECRUITING
Heidelberg
University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centre
RECRUITING
Liverpool
Cabrini Malvern
WITHDRAWN
Malvern
Western Urology
ACTIVE_NOT_RECRUITING
Maribyrnong
Sir Charles Gairdner Hospital
RECRUITING
Nedlands
GenesisCare Newcastle
WITHDRAWN
Newcastle
Australian Prostate Centre
NOT_YET_RECRUITING
North Melbourne
Royal Melbourne Hospital
WITHDRAWN
Parkville
Wide Bay Hospital and Health Service - Hervey Bay Hospital
WITHDRAWN
Pialba
Port Macquarie Base Hospital
WITHDRAWN
Port Macquarie
Tasman Health Care
WITHDRAWN
Southport
Macquarie University Hospital
WITHDRAWN
Sydney
Prince of Wales Hospital NSW
NOT_YET_RECRUITING
Sydney
St Vincents Hospital Sydney
WITHDRAWN
Sydney
Sydney Adventist Hospital
RECRUITING
Wahroonga
Westmead Hospital
WITHDRAWN
Westmead
Austria
Medizinische Universitaet Graz - Klinische Abteilung für Onkologie - Innere Medizin
RECRUITING
Graz
Medizinische Universität Innsbruck
ACTIVE_NOT_RECRUITING
Innsbruck
Ordensklinikum Linz GmbH Elisabethinen
ACTIVE_NOT_RECRUITING
Linz
Uniklinikum Salzburg - Landeskrankenhaus
COMPLETED
Salzburg
Krankenhaus der Barmherzigen Brüder
ACTIVE_NOT_RECRUITING
Vienna
Medizinische Universität Wien- Universitätsklinik für Urologie
ACTIVE_NOT_RECRUITING
Vienna
Belgium
Institut Jules Bordet/Jules Bordet Instituut
WITHDRAWN
Brussels
Maria Middelares General Hospital | Medical Oncology Department
RECRUITING
Ghent
UZ Gent - department Urology
RECRUITING
Ghent
Jessa Hospital | Campus Virga Jesse - Data Management Oncology and Hematology Department
RECRUITING
Hasselt
AZ Groeninge Campus Kennedylaan - Urology
RECRUITING
Kortrijk
Hopital de La Louvière - Site Jolimont - Oncology department
RECRUITING
La Louvière
Universitair Ziekenhuis Leuven | Gasthuisberg Campus - Urology Department
RECRUITING
Leuven
Brazil
NAIC - Instituto do Cancer
NOT_YET_RECRUITING
Bauru
Hospital Sirio Libanês - Hospital Base de Brasilia
WITHDRAWN
Brasília
Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner
RECRUITING
Curitiba
Oncocentro - Fortaleza
RECRUITING
Fortaleza
Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica
RECRUITING
Natal
Hospital Mae de Deus
RECRUITING
Porto Alegre
Hospital Moinhos de Vento-Centro Clínico
RECRUITING
Porto Alegre
Real Hospital Português
WITHDRAWN
Recife
Instituto D'Or Pesquisa e Ensino (IDOR) (D'Or Institute for Research & Education) - Rio de Janeiro
RECRUITING
Rio De Janeiro
Universidade Estadual do Rio de Janeiro
RECRUITING
Rio De Janeiro
Assistência Multidisciplinar em Oncologia (AMO)
RECRUITING
Salvador
Hospital São Rafael
RECRUITING
Salvador
Faculdade de Medicina do ABC
RECRUITING
Santo André
Hospital Alemao Oswaldo Cruz
RECRUITING
São Paulo
Hospital das Clínicas da Universidade de Campinas - UNICAMP
RECRUITING
São Paulo
Hospital do Cancer de Sao Paulo - A. C. Camargo
RECRUITING
São Paulo
Hospital Israelita Albert Einstein | Morumbi - Clinical Research Department
WITHDRAWN
São Paulo
Hospital Sirio Libanes
RECRUITING
São Paulo
Inst. de Assistência Médica ao Sérvidor Público Estadual
RECRUITING
São Paulo
Instituto do Cancer do Estado de Sao Paulo
RECRUITING
São Paulo
Real e Benemérita Associação Portuguesa de Beneficência
RECRUITING
São Paulo
Hospital Evangélico de Cachoeiro de Itapemirim
NOT_YET_RECRUITING
Vitória
Canada
BC Cancer - Abbotsford
RECRUITING
Abbotsford
Prostate Cancer Centre
RECRUITING
Calgary
Kaye Edmonton Clinic - Dianne and Irving Kipnes Urology Centre
RECRUITING
Edmonton
CISSS de l'Outaouais - Hopital de Gatineau - Centre de cancerolgie
RECRUITING
Gatineau
Urology South Shore Research - Research Department
RECRUITING
Greenfield Park
Nova Scotia Health Authority
RECRUITING
Halifax
St. Joseph's Healthcare - Hamilton
RECRUITING
Hamilton
London Health Sciences Centre (LHSC) - London Regional Cancer Program (LRCP)
RECRUITING
London
Hopital Maisonneuve-Rosemont
RECRUITING
Montreal
Sir Mortimer B. Davis Jewish General Hospital - Radiation Oncology
RECRUITING
Montreal
Hôtel-Dieu de Lévis - Urology
RECRUITING
Québec
Centre Hospitalier Universitaire de Sherbrooke (CHUS) - Hopital Fleurimont
RECRUITING
Sherbrooke
Princess Margaret Cancer Centre - Oncology Department
RECRUITING
Toronto
Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-Centre-du-Quebec - Radio-oncologie
RECRUITING
Trois-rivières
Vancouver Prostate Centre
RECRUITING
Vancouver
BC Cancer - Victoria
RECRUITING
Victoria
China
Peking Union Medical College Hospital (PUMCH) - East Location
RECRUITING
Beijing
Peking University First Hospital - Oncology Department
RECRUITING
Beijing
Hunan Cancer Hospital - Oncology Department
RECRUITING
Changsha
West China Hospital,Sichuan University
RECRUITING
Chengdu
The 1st Affiliated Hospital of Zhejiang University
RECRUITING
Hangzhou
The Affiliated Hospital of Inner Mongolia Medical University
NOT_YET_RECRUITING
Hohehot
Jiangsu Provincial People's Hospital - The First Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Nanjing First Hospital
RECRUITING
Nanjing
Fudan University Shanghai Cancer Center - Oncology Department
RECRUITING
Shanghai
Ruijin Hosp. Shanghai Jiaotong Univ.School of Medicine
WITHDRAWN
Shanghai
Tianjin Cancer Hospital, Airport Hospital
RECRUITING
Tianjin
Zhongnan hospital ,Wuhan University
RECRUITING
Wuhan
Denmark
Aalborg University Hospital
ACTIVE_NOT_RECRUITING
Aalborg
Aarhus Universitetshospital
ACTIVE_NOT_RECRUITING
Aarhus N
Rigshospitalet - Kræftbehandling
ACTIVE_NOT_RECRUITING
København Ø
Sjællands University hospital Næstved
ACTIVE_NOT_RECRUITING
Næstved
Finland
Docrates Klinikka
WITHDRAWN
Helsinki
HUS, Meilahden sairaala
RECRUITING
Helsinki
Oulun yliopistollinen sairaala
RECRUITING
Oulu
Tampereen yliopistollinen sairaala
RECRUITING
Tampere
Turun yliopistollinen keskussairaala
RECRUITING
Turku
France
Centre d' Oncologie du Pays Basque Clinique Belharra - Bayonne - Oncologie medicale
RECRUITING
Bayonne
CHRU Besancon - Hopital Jean Minjoz
RECRUITING
Besançon
CHU Bordeaux - Hopital Pellegrin - Service urologie
RECRUITING
Bordeaux
Hopital La Cavale Blanche - CHU de Brest - institut de cancerologie et d'imagerie
RECRUITING
Brest
Centre Hospitalier Universitaire de Clermont Ferrand - Gabriel Montpied - Service Urologie
RECRUITING
Clermont-ferrand
APHP - Hopital Henri Mondor - Departement Urologie
RECRUITING
Créteil
Centre Georges Francois Leclerc Dijon - service de radiotherapie
RECRUITING
Dijon
Institut de cancerologie de Bourgogne - Departement radiotherapie
RECRUITING
Dijon
Center Hospitalier Michallon - Grenoble - Service d Urologie et de la transplantation Renale
RECRUITING
La Tronche
Hopital Claude Huriez - Lille - Urologie
RECRUITING
Lille
Hopital Prive Le Bois - Centre Bourgogne - Service radiotherapie oncologie
RECRUITING
Lille
UNICANCER - Centre Leon-Berard (CLB) - Medical oncology
RECRUITING
Lyon
AP-HM - Hopital de la Timone
NOT_YET_RECRUITING
Marseille
Clinique Clementville
RECRUITING
Montpellier
Hopital Bichat - Paris
WITHDRAWN
Paris
Institut Curie - Paris - Oncologie Radiotherapie
NOT_YET_RECRUITING
Paris
HCL - Centre Hospitalier Lyon Sud
RECRUITING
Pierre-bénite
Institut de Cancerologie Jean Godinot - Departement oncologie medicale
RECRUITING
Reims
CHU Rennes - Hopital Pontchaillou
RECRUITING
Rennes
Institut Curie - Saint-Cloud
NOT_YET_RECRUITING
Saint-cloud
Institut de Cancerologie de l'Ouest - Saint Herblain - Unite de therapie precoce
RECRUITING
Saint-herblain
ICANS - Institut de Cancerologie de Strasbourg Europe
RECRUITING
Strasbourg
Institut Claudius Regaud - iUCT Oncopole - Service oncologie
RECRUITING
Toulouse
CHU Tours - Hopital Bretonneau
COMPLETED
Tours
Institut de Cancérologie de Lorraine - Alexis Vautrin
RECRUITING
Vandœuvre-lès-nancy
Gustave Roussy - Departement Oncologie-Radiotherapie
RECRUITING
Villejuif
Germany
Universitätsklinikum Aachen / Klinik und Poliklinik für Urologie und Kinderurologie
RECRUITING
Aachen
Marien-Krankenhaus Bergisch Gladbach
RECRUITING
Bergisch Gladbach
Charité Campus Benjamin Franklin (CBF)
WITHDRAWN
Berlin
Vivantes Klinikum Am Urban
RECRUITING
Berlin
Städtisches Klinikum Braunschweig gGmbH
RECRUITING
Braunschweig
Universitätsklinikum Köln
NOT_YET_RECRUITING
Cologne
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
RECRUITING
Dresden
Urologicum Duisburg
RECRUITING
Duisburg
Universitätsklinikum der Johann Wolfgang Goethe Universität
RECRUITING
Frankfurt Am Main
Universitätsmedizin der Georg-August-Universität Göttingen
RECRUITING
Göttingen
Universitätsklinikum Hamburg-Eppendorf - Martini-Klinik am UKE GmbH
RECRUITING
Hamburg
Marienhospital Herne Universitätsklinik
RECRUITING
Herne
Universitaetsklinikum Jena - Klinik fuer Urologie
RECRUITING
Jena
Universitätsklinikum Schleswig-Holstein/ Klinik für Urologie
RECRUITING
Kiel
Medizinische Fakultät der Otto-von-Guericke Universität
RECRUITING
Magdeburg
Johannes Gutenberg-Universität Mainz - Urologie
RECRUITING
Mainz
Klinikum Mannheim GmbH
RECRUITING
Mannheim
Klinikum rechts der Isar
NOT_YET_RECRUITING
München
Universitätsklinikum Münster
RECRUITING
Münster
Studienpraxis Urologie
RECRUITING
Nürtingen
Klinikum Stuttgart / Klinik für Urologie und Transplantationschirurgie
RECRUITING
Stuttgart
Urologische Gemeinschaftspraxis Wesel
RECRUITING
Wesel
Klinikum der Universität Würzburg
RECRUITING
Würzburg
Hungary
Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet
RECRUITING
Budapest
Budapesti Uzsoki Utcai Kórház
ACTIVE_NOT_RECRUITING
Budapest
Orszagos Onkologiai Intezet
RECRUITING
Budapest
Semmelweis Egyetem, Altalanos Orvostudomanyi Kar, Urologiai Klinika
RECRUITING
Budapest
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
ACTIVE_NOT_RECRUITING
Győr
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz
ACTIVE_NOT_RECRUITING
Nyíregyháza
Israel
Rambam Health Corporation
WITHDRAWN
Haifa
Hadassah Hebrew University Hospital Ein Kerem
WITHDRAWN
Jerusalem
Shaare Zedek Medical Center
WITHDRAWN
Jerusalem
Rabin Medical Center | Beilinson Hospital - Internal Medicine C Department
WITHDRAWN
Petah Tikva
Sourasky Medical Center
WITHDRAWN
Tel Aviv
Sheba Medical Center
WITHDRAWN
Tel Litwinsky
Italy
Centro di Riferimento Oncologico di Aviano - Oncologia Radioterapica
RECRUITING
Aviano
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
WITHDRAWN
Bari
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Oncologia
RECRUITING
Bergamo
Cliniche Gavazzeni S.p.A - Dipartimento Area Chirurgia Unità Operativa di Urologia
RECRUITING
Bergamo
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - Urologia
RECRUITING
Bologna
Azienda Unita Sanitaria Locale Di Bologna_Ospedale Bellaria - Oncologia Medica
RECRUITING
Bologna
Istituto Oncologico Veneto_Castelfranco Veneto - UOC Urologia Oncologica
RECRUITING
Castelfranco Veneto
Azienda Ospedaliera Santa Croce e Carle - Oncologia
RECRUITING
Cuneo
Azienda Ospedaliero Universitaria Ospedali Riuniti_Foggia - Oncologia Medica e Terapia Biomolecolare Universitaria
RECRUITING
Foggia
IRCCS Ospedale Policlinico San Martino - Oncologia Medica 1
RECRUITING
Genoa
Fondazione IRCCS Istituto Nazionale dei Tumori
WITHDRAWN
Milan
Ospedale San Raffaele s.r.l - Urologia
ACTIVE_NOT_RECRUITING
Milan
Azienda Ospedaliero Universitaria di Modena_Policlinico - Oncologia
RECRUITING
Modena
IRCCS Istituto Nazionale Tumori Fondazione Pascale - S. C. Oncologia Clinica Sperimentale Uro-Ginecologica
RECRUITING
Napoli
A.O. di Perugia_Hospital Santa Maria della Misericordia - S.C. Radioterapia Oncologica
RECRUITING
Perugia
Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia Provinciale
RECRUITING
Reggio Emilia
Azienda Ospedaliera Policlinico Universitario Tor Vergata - UOC Radioterapia
RECRUITING
Roma
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Degenza di Radioterapia Oncologica
RECRUITING
Rome
I.F.O. Istituti Fisioterapici Ospitalieri_Ospedale Regina Elena - Urologia
RECRUITING
Rome
Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia
RECRUITING
Rozzano
Azienda Provinciale Per I Servizi Sanitari_Ospedale Santa Chiara - UO Oncologia Medica
RECRUITING
Trento
A.O.U. Città della Salute e della Scienza di Torino_Molinette - Urologia U
RECRUITING
Turin
A.O.U.I. Verona
WITHDRAWN
Verona
IRCCS Ospedale Sacro Cuore Don Calabria
WITHDRAWN
Verona
Japan
Institute of Science Tokyo Hospital
RECRUITING
Bunkyo-ku
Kagoshima University Hospital
WITHDRAWN
Kagoshima
Kanazawa University Hospital
RECRUITING
Kanazawa
Kyoto University Hospital
RECRUITING
Kyoto
Hokkaido University Hospital
RECRUITING
Sapporo
The University of Osaka Hospital
RECRUITING
Suita
Yokohama City University Hospital
RECRUITING
Yokohama
Netherlands
Albert Schweitzer Hospital | Internal Medicine - Oncology Department
ACTIVE_NOT_RECRUITING
Dordrecht
Catharina Ziekenhuis
WITHDRAWN
Eindhoven
University Medical Center Groningen | Urology Department
ACTIVE_NOT_RECRUITING
Groningen
Tergooi MC | Hilversum - Wetenschapsbureau
RECRUITING
Hilversum
St. Antonius Ziekenhuis | Utrecht - R&D Interne Geneeskunde
ACTIVE_NOT_RECRUITING
Nieuwegein
St. Franciscus Gasthuis
RECRUITING
Rotterdam
HagaZiekenhuis van Den Haag
ACTIVE_NOT_RECRUITING
The Hague
New Zealand
Auckland City Hosptial
RECRUITING
Auckland
Canterbury Urology Research Trust
RECRUITING
Christchurch
Tauranga Urology Research Limited
RECRUITING
Tauranga
MidCentral District Health Board (MDHB) - Palmerston North Hospital (PNH)
RECRUITING
Tbc
Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka
ACTIVE_NOT_RECRUITING
Bydgoszcz
Swietokrzyskie Centrum Onkologii
ACTIVE_NOT_RECRUITING
Kielce
Centrum Medyczne iMed24
RECRUITING
Krakow
Medrise Sp. z o.o. Centrum Badan Klinicznych
RECRUITING
Lublin
Szpital Grochowski im. dr.med. Rafala Masztaka
RECRUITING
Warsaw
EMC Instytut Medyczny SA
RECRUITING
Wroclaw
Portugal
Centro Clinico Academico Braga | Braga, Portugal
WITHDRAWN
Braga
Unidade Local Saúde Coimbra, E.P.E
ACTIVE_NOT_RECRUITING
Coimbra
Companhia Uniao Fabril | Hospital CUF Tejo - Academic Center - Research Center
RECRUITING
Lisbon
Fundacao Champalimaud | Centro Clinico Champalimaud - Unidade Investigacao Clinica
WITHDRAWN
Lisbon
Hospital Santa Maria | Centro de Investigacao Clinica
ACTIVE_NOT_RECRUITING
Lisbon
Instituto Portugues de Oncologia de Lisboa | Unidade de Investigacao Clinica - Departamento de Urologia
ACTIVE_NOT_RECRUITING
Lisbon
Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica
ACTIVE_NOT_RECRUITING
Lisbon
Centro Hospitalar Universitario do Porto
WITHDRAWN
Porto
Spain
Ciutat Sanitaria i Universitaria de la Vall d'Hebron
RECRUITING
Barcelona
Fundacio Puigvert - Urologia
RECRUITING
Barcelona
Hospital Clínic i Provincial de Barcelona
RECRUITING
Barcelona
Hospital del Mar
RECRUITING
Barcelona
Hospital Universitario Puerta del Mar - Urologia
RECRUITING
Cadiz
Hospital Universitario Ramon Y Cajal - Oncologia Radioterapica
RECRUITING
Madrid
MD Anderson International Espanya, S.A. - Oncologia Radioterapica
RECRUITING
Madrid
The START Center for Cancer Care - Madrid - CIOCC - Hospital Universitario Madrid Sanchinarro - Oncologia
RECRUITING
Madrid
Hospital Universitario Virgen De La Victoria - Urologia
RECRUITING
Málaga
Hospital General Universitario Morales Meseguer - Urologia
ACTIVE_NOT_RECRUITING
Murcia
Hospital Universitario Marques De Valdecilla - Urologia
NOT_YET_RECRUITING
Santander
Hospital Clínico Universitario de Santiago de Compostela
RECRUITING
Santiago De Compostela
Hospital Universitario Virgen Del Rocio S.L. - Urologia
RECRUITING
Seville
Hospital Universitario Y Politecnico La Fe - Oncologia Radioterapica
ACTIVE_NOT_RECRUITING
Valencia
Instituto Valenciano de Oncología
ACTIVE_NOT_RECRUITING
Valencia
Sweden
Goteborgs Universitet
ACTIVE_NOT_RECRUITING
Gothenburg
Skane University Hospital - Department of Urology
ACTIVE_NOT_RECRUITING
Malmo
Uppsala University Hospital, Urology Department
WITHDRAWN
Uppsala
Taiwan
Tungs' Taichung MetroHarbor Hospital
RECRUITING
Taichung
Koo Foundation Sun Yet-Sen Cancer Centre
RECRUITING
Taipei
National Taiwan University Hospital
RECRUITING
Taipei
Chang Gung Memorial Hospital at Linkou
RECRUITING
Taoyuan District
United Kingdom
Bedford Hospital - Bedfordshire Hospitals NHS Foundation Tru
WITHDRAWN
Bedford
Royal Surrey NHS Foundation Trust | Royal Surrey County Hospital - Cancer Centre
RECRUITING
Guildford
Imperial College Healthcare NHS Trust | Charing Cross Hospital - Cancer Services
ACTIVE_NOT_RECRUITING
London
The Royal Marsden NHS Foundation Trust | The Royal Marsden Hospital - The Royal Marsden Clinical Trials Unit (CTU)
RECRUITING
London
University College London Hospitals NHS Foundation Trust | University College Hospital (UCLH) - Cancer Clinical Trials Unit
RECRUITING
London
East and North Hertfordshire NHS Trust - Mount Vernon Hospital - Mount Vernon Cancer Centre (MVCC)
RECRUITING
Northwood
Contact Information
Primary
Bayer Clinical Trials Contact
clinical-trials-contact@bayer.com
(+)1-888-84 22937
Time Frame
Start Date: 2023-04-03
Estimated Completion Date: 2030-03-29
Participants
Target number of participants: 970
Treatments
Experimental: Darolutamide+ADT
Participants will receive darolutamide plus ADT twice daily with food for a pre-specified duration of 24 months.
Placebo_comparator: Placebo+ADT
Participants will receive Placebo plus ADT twice daily with food for a pre-specified duration of 24 months.
Related Therapeutic Areas
Sponsors
Leads: Bayer

This content was sourced from clinicaltrials.gov

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