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A phase 2 Randomized Open-Label Study of Oral darolutamide (ODM-201) vs. androgen deprivation therapy (ADT) with LHRH agonists or antagonist in Men with Hormone Naive Prostate Cancer

Study documentation

Trial Status Recruiting
Dates Date of activation: 01-Dec-2017
Data management at EORTC Yes
Design Phase 2
Randomized open label
Targeted Sample size EORTC Groups: 250 - All Groups: 250
Treatment Drug
ODM-201, Leuprorelin acetate, Goserelin acetate, Triptorelin acetate, Triptorelin pamoate, Degarelix acetate
Study Staff Bertrand Tombal (Study Coordinator) , Cliniques Universitaires Saint-Luc, Brussels
Hazal Erkol (Data Manager) , EORTC Headquarters, Brussels
Catherine Fortpied (Statistician) , EORTC Headquarters, Brussels
Beatrice Fournier (Clinical Scientist) , EORTC Headquarters, Brussels
Claire Gandilhon (Clinical Operations Assistant) , EORTC Headquarters, Brussels
Joanna Krzystyniak (Clinical Operations Manager) , EORTC Headquarters, Brussels
Belma Malanda (Project Manager) , EORTC Headquarters, Brussels
Miguel Remis (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels
Jelle Stans (Regulatory Affairs Manager) , EORTC Headquarters, Brussels
Laurens Vinckier (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Christine de Balincourt (Lead CRA) , EORTC Headquarters, Brussels
Gaetan de Schaetzen (Senior Clinical Operations Manager) , EORTC Headquarters, Brussels
Type of cancer Prostate
Participating groups EORTC Genito-Urinary Cancers Group
Recruiting centers Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale Molinette (Torino, Italy)
CHU Mont Godinne - UCL Namur (Yvoir, Belgium)
CHU de Limoges - Hopital Dupuytren (LIMOGES CEDEX 1, France)
Centre Georges-Francois-Leclerc (DIJON CEDEX, France)
Cliniques Universitaires Saint-Luc (Brussels, Belgium)
Fundacion Instituto Valenciano De Oncologia (Valencia, Spain)
Gustave Roussy (VILLEJUIF CEDEX, France)
Hopital Universitaires Erasme (Brussels, Belgium)
Hospital Universitario Ramon y Cajal (Madrid, Spain)
Hospital Universitario Virgen De La Victoria (Malaga, Spain)
Hospital Universitario de Salamanca (Salamanca, Spain)
Hospital Universitario de Salamanca (Salamanca, Spain)
ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) (Badalona - (Barcelona), Spain)
Medical University of Graz (Graz, Austria)
National Cancer Institute - Cairo (Cairo, Egypt)
Universitair Ziekenhuis Gent (Gent, Belgium)
Centers to be activated AO Ospedale di Circolo di Busto Arsizio (Busto Arsizio, Italy)
ATURO Urologie praxis (Berlin, Germany)
Ain Shams University Hospital (Cairo, Egypt)
Helios Haus Koeln - Urologgia (Koeln, Germany)
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" (Meldola, Italy)
Medical University of Graz-Urology (Graz, Austria)
Ospedale B. Ramazzini (Carpi, Italy)
Ospedale San Carlo Borromeo (Milano, Italy)
San Camillo Forlanini Hospitals (Roma, Italy)
San Camillo Forlanini Hospitals (Roma, Italy)
Schlosscaree Braunschweig (Braunschweig, Germany)
UPK - Urologie Bayenthal (Koeln, Germany)
URO-logicum (Lutherstadt Eisleben, Germany)
Urologicum Duisburg (Duisburg, Germany)
Urologie Neandertal - Mettmann (Mettmann, Germany)
Urologie Pankow (Berlin, Germany)
Urologikum Hamburg MVZ (Hamburg, Germany)
Urologische Fachpraxis Johannsen-Laux (Berlin, Germany)
Urologische Gemeinschaftspraxis Buxtehude (Buxtehude, Germany)
Protocol summary
NCT number NCT02972060
EudraCT 2016-004334-17
Financial Support Educational Grant