Clinical Trial Details

EORTC-1414-GUCG-ROG

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Phase IIIb randomized trial comparing irradiation plus long term adjuvant androgen deprivation with GnRH antagonist versus GnRH agonist plus flare protection in patients with very high risk localized or locally advanced prostate cancer. A joint study of the EORTC ROG and GUCG

Study documentation

Trial Status Closed to Patient Entry
Dates Date of activation: 25-Sep-2017
Date Step1 close: 06-Feb-2023
Data management at EORTC Yes
Design Phase 3
Randomized open label
Targeted Sample size EORTC Groups: 885 - All Groups: 885
Treatment Radiotherapy, Drug
Goserelin, Triptorelin, Leuprorelin, Degarelix
Study Staff Pedro Lara (Study Coordinator) , San Roque University Hospital, Las Palmas de Gran Canaria
Dirk Boehmer (Study Co-Coordinator) , Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin, Berlin
Ilse Coppens (Clinical Operations Assistant) , EORTC Headquarters, Brussels
Coreen Corning (QART Manager) , EORTC Headquarters, Brussels
David D'Haese (Statistician) , EORTC Headquarters, Brussels
Jozefien Debruyne (Junior PVM) , EORTC Headquarters, Brussels
Laura Decubber (Data Manager) , EORTC Headquarters, Brussels
Catherine Fortpied (Statistician) , EORTC Headquarters, Brussels
Beatrice Fournier (Clinical Scientist) , EORTC Headquarters, Brussels
Amaya Gonzalez (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels
Lore Hermans (Regulatory Affairs Manager) , EORTC Headquarters, Brussels
Belma Malanda (Project Manager) , EORTC Headquarters, Brussels
Zara Nasir (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
David Ndah Aki (Clinical Operations Manager) , EORTC Headquarters, Brussels
Daniel Portik (Medical Fellow) , EORTC Headquarters, Brussels
Miguel Remis (Lead CRA) , EORTC Headquarters, Brussels
Martin Spahn (Study Co-Coordinator) , Hirslanden Klinik Zurich, Zurich
Eliza Starczewska (Junior RAM) , EORTC Headquarters, Brussels
Bertrand Tombal (Study Co-Coordinator) , Cliniques Universitaires Saint-Luc, Brussels
Laurens Vinckier (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Gaetan de Schaetzen (Senior Clinical Operations Manager) , EORTC Headquarters, Brussels
Type of cancer Prostate
Participating groups EORTC Genito-Urinary Cancers Group
EORTC Radiation Oncology Group
Recruiting centers APHP - Hop. Univ. Henri Mondor (Creteil, France)
APHP Sorbonne Univ - Hopital la Pitie-Salpetriere (PARIS, France)
AZ Groeninge Kortrijk - Campus Kennedylaan (Kortrijk, Belgium)
CHU Helora Pole Hospitalier Jolimont - Hopital Jolimont (Haine-Saint-Paul, Belgium)
CHU Helora Pole Hospitalier Jolimont - Hopital Jolimont (Haine-Saint-Paul, Belgium)
CHU Site Sainte-Elisabeth-UCL Namur (Namur, Belgium)
CHU de Grenoble - La Tronche - Hopital A. Michallon (GRENOBLE CEDEX 9, France)
Centre D'Onco. & Radioth. De Haute Energie Du Pays Basque (Bayonne, France)
Centre Georges-Francois-Leclerc (DIJON CEDEX, France)
Centre Leon Berard (Lyon, France)
Centre de Radiotherapie Pierre Curie (Beuvry, France)
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin (Berlin, Germany)
Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (Berlin, Germany)
Clinica IMQ Zorrotzaurre (Bilbao, Spain)
Clinique Pasteur-Toulouse-Atrium (Toulouse Cedex 3, France)
Clinique Victor Pauchet (Amiens, France)
Clinique Victor Pauchet (Amiens, France)
Cliniques Universitaires Saint-Luc (Brussels, Belgium)
Complejo Hospitalario de Navarra (Pamplona, Spain)
GasthuisZusters Antwerpen - Sint-Augustinus (Wilrijk, Belgium)
Hopital Universitaires Erasme (Brussels, Belgium)
Hopitaux universitaires de Geneve - HUG - site de Cluse-Roseraie (Geneve, Switzerland)
Hopitaux universitaires de Geneve - HUG - site de Cluse-Roseraie (Geneve, Switzerland)
Hospital Alvaro Cunqueiro (Vigo, Spain)
Hospital Consorci Sanitari De Terrassa (Terrassa, Spain)
Hospital General Universitario Santa Lucia (Cartagena, Spain)
Hospital Universitario Fundacion Alcorcon (Alcorcon - Madrid, Spain)
Hospital Universitario Reina Sofia (Cordoba, Spain)
Hospital Universitario Virgen De La Victoria (Malaga, Spain)
Hospital Universitario de Gran Canaria Doctor Negrin (Las Palmas de Gran Canaria, Spain)
Hospital Universitario de Salamanca - Hosp Virgen De la Vega (Salamanca, Spain)
ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) (Badalona - (Barcelona), Spain)
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" (Meldola, Italy)
Inselspital (Bern, Switzerland)
Institut Jules Bordet (Anderlecht, Belgium)
Institut de Cancerologie de l’Ouest (ICO) - Angers (ANGERS CEDEX 02, France)
Institut de Cancerologie de l’Ouest (ICO) - Angers (ANGERS CEDEX 02, France)
Institut de Cancerologie de l’Ouest (ICO) - Saint Herblain (Saint Herblain CEDEX, France)
Northern Lincolnshire and Goole Hospitals NHS Foundation Trust - Diana, Princess of Wales Hospital (Grimsby, United Kingdom)
Northern Lincolnshire and Goole Hospitals NHS Foundation Trust - Scunthorpe General Hospital (Scunthorpe, United Kingdom)
Nottingham University Hospitals NHS Trust - City Hospital (Nottingham, United Kingdom)
Oncology Institute of Southern Switzerland - Ospedale San Giovanni (Bellinzona, Switzerland)
Otto-Von-Guericke-Universitaet Magdeburg - Universitaetsklinik (Magdeburg, Germany)
Parc Tauli Hospital Universitari (Sabadell Barcelona, Spain)
Rigshospitalet (Copenhagen, Denmark)
Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi (Firenze, Italy)
Universitaetsklinikum Freiburg (Freiburg, Germany)
Universitair Ziekenhuis Brussel (Brussels, Belgium)
Protocol summary http://clinicaltrials.gov/study/NCT02799706
NCT number NCT02799706
EudraCT 2015-005098-19
Financial Support Educational Grant