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A Randomized multicenter phase III trial comparing enzalutamide vs. a combination of Ra223 and enzalutamide in asymptomatic or mildly symptomatic castration resistant prostate cancer patients metastatic to bone.

Study documentation

Trial Status Recruiting
Dates Date of activation: 20-Oct-2015
Data management at EORTC Yes
Design Phase 3
Randomized open label
Targeted Sample size EORTC Groups: 464 - All Groups: 560
Treatment Drug
Enzalutamide, Radium Ra223 dichloride
Study Staff Laurence Collette (Statistician) laurence.collette (at), EORTC Headquarters, Brussels
Beatrice Fournier (Clinical Scientist) beatrice.fournier (at), EORTC Headquarters, Brussels
Claire Gandilhon (Clinical Operations Assistant) claire.gandilhon (at), EORTC Headquarters, Brussels
Pieter Jespers (Imaging Officer) pieter.jespers (at), EORTC Headquarters, Brussels
Joanna Krzystyniak (Junior Clinical Operations Manager) joanna.krzystyniak (at), EORTC Headquarters, Brussels
Livia Meirsman (Project Manager) livia.meirsman (at), EORTC Headquarters, Brussels
Sara Meloen (Pharmacovigilance Manager) sara.meloen (at), EORTC Headquarters, Brussels
Joana Mendes (Regulatory Affairs Administrator) joana.mendes (at), EORTC Headquarters, Brussels
Anouk Neven (Statistician) anouk.neven (at), EORTC Headquarters, Brussels
Bassem Osmani (Data Manager) bassem.osmani (at), EORTC Headquarters, Brussels
Gilles Sarlet (Regulatory Affairs Manager) gilles.sarlet (at), EORTC Headquarters, Brussels
Laurens Vinckier (Pharmacovigilance Manager) laurens.vinckier (at), EORTC Headquarters, Brussels
Christine de Balincourt (Lead CRA) christine.debalincourt (at), EORTC Headquarters, Brussels
Gaetan de Schaetzen (Senior Clinical Operations Manager) gaetan.deschaetzen (at), EORTC Headquarters, Brussels
Type of cancer Prostate
Participating groups EORTC Genito-Urinary Cancers Group
Groupe d'Etude des Tumeurs Uro-Genitales
Cancer Trials Ireland
Canadian Urologic Oncology Group
Academic and Community Cancer Research United
Recruiting centers AZ Groeninge Kortrijk - Campus Kennedylaan (Kortrijk, Belgium)
AZ Turnhout - Campus Sint Elisabeth (Turnhout, Belgium)
Akershus University Hospital (lorenskog, Norway)
Assistance Publique - Hopitaux de Paris - CHU Henri Mondor (Creteil, France)
CHU Mont Godinne - UCL Namur (Yvoir, Belgium)
CHU Site Sainte-Elisabeth-UCL Namur (Namur, Belgium)
CHU de Nimes - Hopital Caremeau (Nimes, France)
Centre Hospitalier de l'Université de Montreal - Pavillon Saint-Luc (Montreal, Quebec, Canada)
Chuq-Pavillon Hotel-Dieu De Quebec (Quebec, Canada)
Cliniques Universitaires Saint-Luc (Brussels, Belgium)
Complejo Hospitalario de Navarra (Pamplona, Spain)
Cork University Hospital (Cork, Ireland)
Corporacio Sanitaria Parc Tauli (Sabadell Barcelona, Spain)
Gustave Roussy (Villejuif, France)
Hopital Universitaire Brugmann (Brussels, Belgium)
Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme (Brussels, Belgium)
Hospital Clinic Universitari de Barcelona (Barcelona, Spain)
Hospital De La Santa Creu I Sant Pau (Barcelona, Spain)
Hospital Del Mar (Barcelona, Spain)
Hospital Universitario QuironSalud (Madrid, Spain)
Hospital Universitario QuironSalud (Madrid, Spain)
Hospital Universitario Ramon y Cajal (Madrid, Spain)
Hospital Universitario de Gran Canaria Doctor Negrin (Las Palmas de Gran Canaria, Spain)
Hospital Universitario de La Princesa (Madrid, Spain)
Hospital Universitario de Salamanca (Salamanca, Spain)
Hôpitaux Universitaires de Strasbourg - Hôpital civil (Strasbourg, France)
Inselspital (Bern, Switzerland)
Institut de Cancerologie de l’Ouest (ICO) - Centre Paul Papin (Angers, France)
Institut de Cancerologie de l’Ouest (ICO) - Centre Rene Gauducheau (Nantes - St. Herblain, France)
Institut du Cancer de Montpellier (Montpellier, France)
Istituto Europeo di Oncologia (Milano, Italy)
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (Meldola, Italy)
Kantonsspital St Gallen (St Gallen, Switzerland)
Maria Sklodowska-Curie Memorial Cancer Centre (Warsaw, Poland)
Maria Sklodowska-Curie Memorial Cancer Centre (Warsaw, Poland)
Nottingham University Hospitals NHS Trust - City Hospital (Nottingham, United Kingdom)
Ospedale B. Ramazzini (Carpi, Italy)
Rigshospitalet (Copenhagen, Denmark)
Soerlandet Sykehus-Kristiansand (Kristiansand, Norway)
St. Vincent'S University Hospital (Dublin, Ireland)
Stavanger University Hospital (Stavanger, Norway)
Tallaght University Hospital (Dublin , Ireland)
The Christie NHS Foundation Trust (Manchester, United Kingdom)
The Christie NHS Foundation Trust (Manchester, United Kingdom)
UniversitaetsSpital Zurich (Zurich, Switzerland)
Universitair Ziekenhuis Antwerpen (Edegem, Belgium)
University Hospital of North Norway (Tromsoe, Norway)
Vall d'Hebron Institut d’Oncologia (Barcelona, Spain)
Centers to be activated CHRU de Besancon - Hopital Jean Minjoz (Besancon, France)
CHU de Lyon - Hopital Lyon Sud (Pierre-Benite (Lyon), France)
Cancercare Manitoba (Winnipeg, Canada)
Centre Francois Baclesse (CLCC) (Caen, France)
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont (Sherbrooke, Canada)
Centre Leon Berard (Lyon, France)
Hamilton And District Urology Association (Hamilton, Ontario, Canada)
Hospital Universitario Virgen De La Victoria (Malaga, Spain)
Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital (Cottingham, United Kingdom)
Institut Curie- Hopital de Paris (Paris, France)
London Regional Cancer Center (London, Canada)
San Camillo Forlanini Hospitals (Roma, Italy)
St. Olavs Hospital, Trondheim University Hospital (Trondheim, Norway)
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
University Health Network - Oci / Princess Margaret Hospital (Toronto, Canada)
Protocol summary
NCT number NCT02194842
EudraCT 2014-001787-36