Spots Global Cancer Trial Database for Comparison of HT Concomitant With RT vs RT Alone in Patients With a Detectable PSA After Prostatectomy
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Trial Identification
Brief Title: Comparison of HT Concomitant With RT vs RT Alone in Patients With a Detectable PSA After Prostatectomy
Official Title: A Multicenter Randomised Phase II Study Comparing the Efficiency of a HT Concomitant With RT vs RT Alone in the Salvage of Patients With a Detectable PSA After Prostatectomy
Study ID: NCT01994239
Conditions
Study Description
Brief Summary: The purpose of this study is to select the best therapeutic strategy in studying the effectiveness of the association of a short duration hormonal therapy and radiotherapy compared with radiotherapy alone, in patients with a detectable PSA after radical prostatectomy.
Detailed Description: Study the effectiveness of the association of a short duration hormonal therapy by degarelix (Firmagon ®) and radiotherapy, with radiotherapy alone on survival without events in the treatment of detectable PSA after radical prostatectomy. 122 patients should be included over a period of 2 years. Patients will be treated according to the following scheme: * Arm A (61 patients) : Pelvic Radiotherapy: 46 Gy and prostate only boost up to 66 Gy * Arm B (61 patients) : Arm A + hormonal therapy by degarelix during 6 months
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Institut de Cancérologie de l'Ouest -Site Paul Papin, Angers, , France
Institut Sainte Catherine, Avignon, , France
Chu Jean Minjoz, Besançon, , France
Institut Bergonié, Bordeaux, , France
Centre d'oncologie - Clinique Pasteur, Brest, , France
Centre François Baclesse, Caen, , France
Centre hospitalier de Chambéry, Chambéry, , France
Hôpital Henri Mondor, Créteil, , France
Centre d'oncologie et de radiothérapie du Parc, Dijon, , France
Centre Georges François Leclerc, Dijon, , France
Clinique Sainte-Marguerite, Hyeres, , France
Chd Vendee, La Roche-sur-Yon, , France
Centre Leon Berard, Lyon, , France
Clinique Clairval, Marseille, , France
CHU La Timone - Hôpital Nord, Marseille, , France
Groupe Oncorad Garonne Clinique Du Pont de Chaume, Montauban, , France
Ghi Le Raincy / Montfermeil, Montfermeil, , France
Centre Azureen de Cancerologie, Mougins, , France
Centre Hospitalier Emile Muller, Mulhouse, , France
Institut de Cancerologie de Lorraine, Nancy, , France
Centre Antoine Lacassagne, Nice, , France
Chu Caremeau, Nîmes, , France
CHR Orléans La Source, Orléans, , France
Hôpital d'Instruction des Armées du Val de Grâce, Paris, , France
Hôpital Saint Louis, Paris, , France
Centre Hospitalier Lyon Sud, Pierre-Bénite, , France
CHU de POITIERS, Poitiers, , France
Institut Jean Godinot, Reims, , France
Centre Henri Becquerel, Rouen, , France
CHP Saint Grégoire, Saint Gregoire, , France
Clinique Cote Emeraude, Saint Malo, , France
Clinique Armoricaine de Radiologie, Saint-Brieuc, , France
Institut de Cancérologie de l'Ouest René Gauducheau, Saint-Herblain, , France
Clinique Mutualiste de l'Estuaire, Saint-Nazaire, , France
Institut de Cancérologie LUCIEN NEUWIRTH, Saint-Priest-en-Jarez, , France
Hôpitaux du Léman, Thonon-les-Bains, , France
Groupe Oncorad Garonne, Toulouse, , France
Centre Marie Curie, Valence, , France
GUSTAVE ROUSSY, Cancer Campus, Grand Paris, Villejuif, , France
Contact Details
Name: Igor LATORZEFF
Affiliation: Clinique Pasteur
Role: PRINCIPAL_INVESTIGATOR
Name: Laurent SALOMON
Affiliation: CHU Henri Mondor
Role: PRINCIPAL_INVESTIGATOR
Name: Paul SARGOS
Affiliation: Institut Bergonié
Role: PRINCIPAL_INVESTIGATOR
Name: Emmanuel MEYER
Affiliation: Centre François Baclesse
Role: PRINCIPAL_INVESTIGATOR
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