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Brief Title: Phase III Radium 223 mCRPC-PEACE III
Official Title: 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 ID: NCT02194842
Brief Summary: The primary objective of the trial is to assess if upfront combination of enzalutamide and Ra223 improves radiological progression-free survival (rPFS1) compared to enzalutamide single agent in CRPC patients metastatic to bone
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Hopital Universitaire Brugmann, Brussels, , Belgium
Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme, Brussels, , Belgium
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
Universitair Ziekenhuis Antwerpen, Edegem, , Belgium
AZ Groeninge Kortrijk, Kortrijk, , Belgium
U.Z. Leuven - Campus Gasthuisberg, Leuven, , Belgium
AZ Turnhout, Turnhout, , Belgium
CHU Dinant Godinne - UCL Namur, Yvoir, , Belgium
Hospital de Amor, Barretos, , Brazil
Hospital Erasto Gaertner, Curitiba, , Brazil
Centro Pesquisas Oncologicas, Florianópolis, , Brazil
Oncocentro, Fortaleza, , Brazil
Hospital Moinhos de Vento, Porto Alegre, , Brazil
Centro de Pesquisas Clinicas em Oncologia - Hospital Sao Lucas, Porto Alegre, , Brazil
Instituto de Medicina Integral Professor Fernando Figueira - IMIP, Recife, , Brazil
Centro de Tratamentos de Tumores Botafogo, Rio De Janeiro, , Brazil
Clínica Oncológica - CLION, Salvador, , Brazil
Centro de Estudos e Pesquisa Hematologia e Oncologia, Santo André, , Brazil
Hospital Beneficencia Portuguesa, São Paulo, , Brazil
Hospital Paulistano, São Paulo, , Brazil
Sao Camilo Oncologia - Instituto Brasileiro de Controle do Cancer, São Paulo, , Brazil
Saint John Regional Hospital, Saint John, New Brunswick, Canada
Hamilton And District Urology Association, Hamilton, Ontario, Canada
London Regional Cancer Center, London, Ontario, Canada
Odette Cancer Centre - Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
University Health Network - Oci Princess Margaret Hospital, Toronto, Ontario, Canada
Centre de sante et de services sociaux de Chicoutimi, Chicoutimi, Quebec, Canada
CHUM - Centre Hospitalier de l'Université de Montreal - Pavillon Saint-Luc, Montréal, Quebec, Canada
Chuq-Pavillon Hotel-Dieu De Quebec, Québec, Quebec, Canada
Rigshospitalet, Copenhagen, , Denmark
Institut de Cancerologie de l'Ouest (ICO) - Centre Paul Papin, Angers, , France
Centre Francois Baclesse, Caen, , France
Assistance Publique - Hopitaux de Paris - CHU Henri Mondor, Créteil, , France
Centre Leon Berard, Lyon, , France
Institut régional du Cancer Montpellier, Montpellier, , France
Institut de Cancerologie de l'Ouest (ICO) - Centre Rene Gauducheau, Saint-Herblain, , France
Hopitaux Universitaires de Strasbourg - Hôpitaux Universitaires de Strasbourg - Hôpital civil, Strasbourg, , France
Gustave Roussy, Villejuif, , France
Cork University Hospital, Cork, , Ireland
St. Vincent's University Hospital, Dublin, , Ireland
Tallaght University Hospital, Dublin, , Ireland
Ospedale B.Ramazzini, Carpi, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, , Italy
Istituto Europeo di Oncologia, Milano, , Italy
Soerlandet Sykehus-Kristiansand, Kristiansand, , Norway
University Hospital of North Norway, Tromsø, , Norway
Maria Sklodowska-Curie Memorial Cancer Centre, Warsaw, , Poland
Hospital Del Mar, Barcelona, , Spain
Vall d'Hebron Institut d'Oncologia, Barcelona, , Spain
Hospital Clinic Universitari de Barcelona, Barcelona, , Spain
Hospital De La Santa Creu I Sant Pau, Barcelona, , Spain
Hospital Universitario de La Princesa, Madrid, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Universitario QuironSalud, Madrid, , Spain
Complejo Hospitalario de Navarra, Pamplona, , Spain
Corporacio Sanitaria Parc Tauli, Sabadell, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Oncology Institute of Southern Switzerland - Ospedale San Giovanni, Bellinzona, , Switzerland
Kantonsspital St Gallen, St Gallen, , Switzerland
UniversitaetsSpital Zurich, Zurich, , Switzerland
United Lincolnshire Hospitals NHS Trust - Lincoln County Hospital, Lincoln, , United Kingdom
Royal Marsden Hospital - Chelsea, London, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Nottingham University Hospitals NHS Trust - City Hospital, Nottingham, , United Kingdom
Name: Bertrand Tombal, Prof
Affiliation: Cliniques Universitaires de Saint Luc
Role: STUDY_CHAIR
Name: Silke Gillessen, Prof
Affiliation: Oncology Institute of Southern Switzerland - Ospedale San Giovanni
Role: STUDY_CHAIR