Clinical Trial Details
EORTC-1532-GUCG
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A phase 2 Randomized Open-Label Study of Oral ODM-201 vs. androgen deprivation therapy (ADT) with LHRH agonists or antagonist in Men with Hormone Naive Prostate Cancer
| 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 Cherelle Clarke (Regulatory Affairs Administrator) cherelle.clarke (at) eortc.org, EORTC Headquarters, Brussels Beatrice Fournier (Clinical Scientist) beatrice.fournier (at) eortc.org, EORTC Headquarters, Brussels Claire Gandilhon (Clinical Operations Assistant) claire.gandilhon (at) eortc.org, EORTC Headquarters, Brussels Joanna Krzystyniak (Clinical Operations Manager) joanna.krzystyniak (at) eortc.org, EORTC Headquarters, Brussels Anouk Neven (Statistician) anouk.neven (at) eortc.org, EORTC Headquarters, Brussels Miguel Remis (Clinical Research Associate/Monitor) miguel.remis (at) eortc.org, EORTC Headquarters, Brussels Nabila Sebti (Data Manager) nabila.sebti (at) eortc.org, EORTC Headquarters, Brussels Jelle Stans (Regulatory Affairs Manager) jelle.stans (at) eortc.org, EORTC Headquarters, Brussels Laurens Vinckier (Pharmacovigilance Manager) laurens.vinckier (at) eortc.org, EORTC Headquarters, Brussels Christine de Balincourt (Lead CRA) christine.debalincourt (at) eortc.org, EORTC Headquarters, Brussels Gaetan de Schaetzen (Senior Clinical Operations Manager) gaetan.deschaetzen (at) eortc.org, EORTC Headquarters, Brussels |
| Type of cancer | Prostate |
| Participating groups |
EORTC Genito-Urinary Cancers Group DEUTSCHE URO-ONKOLOGEN E.V. |
| 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, France) Centre Georges-Francois-Leclerc (Dijon, France) Cliniques Universitaires Saint-Luc (Brussels, Belgium) Fundacion Instituto Valenciano De Oncologia (Valencia, Spain) Gustave Roussy (Villejuif, 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) ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) (Badalona - (Barcelona), Spain) Medical University of Graz (Graz, Austria) National Cancer Institute (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) 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 | http://clinicaltrials.gov/ct/show/NCT02972060 |
| NCT number | NCT02972060 |
| EudraCT | 2016-004334-17 |