Clinical Trial Details

EORTC-1414-ROG-GUCG

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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 Recruiting
Dates Date of activation: 25-Sep-2017
Data management at EORTC Yes
Design Phase 3
Randomized open label
Targeted Sample size All Groups: 885
Treatment Radiotherapy, Drug
Degarelix, Leuprorelin acetate, Goserelin acetate, Triptorelin acetate, Triptorelin pamoate
Study Staff Dirk Boehmer (Study Coordinator) , Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin, Berlin
Pedro Lara (Study Coordinator) , San Roque University Hospital, Las Palmas de Gran Canaria
Bertrand Tombal (Study Coordinator) , Cliniques Universitaires Saint-Luc, Brussels
Kimberley Ceulemans (Lead CRA) kimberley.ceulemans (at) eortc.org, EORTC Headquarters, Brussels
Laurence Collette (Statistician) laurence.collette (at) eortc.org, EORTC Headquarters, Brussels
Coreen Corning (QART Manager) coreen.corning (at) eortc.org, EORTC Headquarters, Brussels
Beatrice Fournier (Clinical Scientist) beatrice.fournier (at) eortc.org, EORTC Headquarters, Brussels
Julie Hermans (Regulatory Affairs Manager) julie.hermans (at) eortc.org, EORTC Headquarters, Brussels
Fiona Namanya (Clinical Trial Assistant) fiona.namanya (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
Ionela Stanciu (Junior Clinical Operations Manager) ionela.stanciu (at) eortc.org, EORTC Headquarters, Brussels
Eliza Starczewska (Regulatory Affairs Administrator) eliza.starczewska (at) eortc.org, EORTC Headquarters, Brussels
Christophe Verstegen (Clinical Operations Manager) christophe.verstegen (at) eortc.org, EORTC Headquarters, Brussels
Laurens Vinckier (Pharmacovigilance Manager) laurens.vinckier (at) eortc.org, EORTC Headquarters, Brussels
Type of cancer Prostate
Participating groups EORTC Genito-Urinary Cancers Group
EORTC Radiation Oncology Group
Recruiting centers AZ Groeninge Kortrijk - Campus Kennedylaan (Kortrijk, Belgium)
Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere (Paris, France)
Azienda Ospedaliero-Universitaria Careggi (Firenze, Italy)
CHU Site Sainte-Elisabeth-UCL Namur (Namur, Belgium)
CHU de Grenoble - La Tronche - Hôpital A. Michallon (Grenoble, France)
Centre Hospitalier Privé Saint-Grégoire (Saint-Gregoire, France)
Centre Leon Berard (Lyon, France)
Centre de Radiotherapie Pierre Curie (Beuvry, France)
Centre de radiotherapie Marie Curie (Arras, France)
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin (Berlin, Germany)
Clinica IMQ Zorrotzaurre (Bilbao, Spain)
Clinique Pasteur-Toulouse-Atrium (Toulouse, France)
Clinique de l'Europe (Amiens, France)
Cliniques Universitaires Saint-Luc (Brussels, Belgium)
Complejo Hospitalario A (Pamplona, Spain)
Corporacio Sanitaria Parc Tauli (Sabadell, Spain)
Fundacion Hospital Alcorcon (Alcorcon - Madrid, Spain)
GasthuisZusters Antwerpen - Sint-Augustinus (Wilrijk, Belgium)
Hopital De Jolimont (Haine St Paul, Belgium)
Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme (Brussels, Belgium)
Hospital Alvaro Cunqueiro (Vigo, Spain)
Hospital Universitario Reina Sofia (Cordoba, Spain)
Hospital Universitario de Gran Canaria Doctor Negrin (Las Palmas de Gran Canaria, Spain)
Hospital Universitario de Salamanca (Salamanca, Spain)
Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie (Geneve, Switzerland)
ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) (Badalona - (Barcelona), Spain)
Inselspital (Bern, Switzerland)
Institut Jules Bordet-Hopital Universitaire ULB (Brussels, Belgium)
Institut de Cancerologie de l’Ouest (ICO) - Centre Rene Gauducheau (Nantes - St. Herblain, France)
Krankenhaus Barmherzige Schwestern (Linz, Austria)
Oncology Institute of Southern Switzerland - Ospedale Regionale Bellinzona e Valli (Bellinzona, Switzerland)
Oncology Institute of Southern Switzerland - Ospedale Regionale Bellinzona e Valli (Bellinzona, Switzerland)
Otto-Von-Guericke-Universitaet Magdeburg - Universitaetsklinik (Magdeburg, Germany)
Rigshospitalet (Copenhagen, Denmark)
Universitaetsklinikum Freiburg (Freiburg, Germany)
Universitair Ziekenhuis Brussel (Brussels, Belgium)
Centers to be activated Assistance Publique - Hopitaux de Paris - CHU Henri Mondor (Creteil, France)
Centre D'Onco. & Radioth. De Haute Energie Du Pays Basque (Bayonne, France)
Centre Georges-Francois-Leclerc (Dijon, France)
Centre Georges-Francois-Leclerc (Dijon, France)
Centre Hospitalier Departemental Vendée (La Roche Sur Yon, France)
Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (Berlin, Germany)
Guy s and St Thomas' NHS - Guy's Hospital (London, United Kingdom)
Hirslanden Klinik Zurich (Zurich, Switzerland)
Hospital Consorci Sanitari De Terrassa (Terrassa, Spain)
Hospital Escolar Sao Joao (Porto, Portugal)
Hospital General Universitario Santa Lucia (Cartagena, Spain)
Hospital Universitario Virgen De La Victoria (Malaga, Spain)
Institut de Cancerologie de l’Ouest (ICO) - Centre Paul Papin (Angers, France)
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (Meldola, Italy)
Northern Lincolnshire and Goole Hospitals NHS Foundation Trust - Scunthorpe General Hospital (Scunthorpe, United Kingdom)
Nottingham University Hospitals NHS Trust - City Hospital (Nottingham, United Kingdom)
Ospedale Niguarda Ca Granda (Milano, Italy)
Universitaetsklinikum - Essen (Essen, Germany)
Protocol summary http://clinicaltrials.gov/ct/show/NCT02799706
NCT number NCT02799706
EudraCT 2015-005098-19