A Phase III of Cabazitaxel and Pelvic Radiotherapy in Localized Prostate Cancer and High-risk Features of Relapse
NCT01952223 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 761
Last updated 2025-07-30
Summary
The objective of this study is to assess the effect of neoadjuvant cabazitaxel and pelvic radiotherapy in combination with androgen deprivation therapy (ADT)-radiotherapy on clinical progression-free survival in patients with high-risk localized prostate cancer (with a stringent selection of patients with at least 2 high-risk features), in a 2 by 2 factorial trial.
Conditions
- Adenocarcinoma of Prostate
- Progression of Prostate Cancer
Interventions
- DRUG
-
Cabazitaxel
Cabazitaxel administered at 25 mg/m² as a 1 hour intravenous infusion every 3 weeks (1 cycle = 21 days) for 4 cycles
- RADIATION
-
Pelvic radiotherapy
Prostate+pelvic RT (2 Gy fractions, 5 times per week): * Phase 1: pelvic radiotherapy (prostate, seminal vesicles, ilio-obturator, presacral lymph nodes) (46 or 50 Gy according to the center) * Phase 2: prostate-only boost (EBRT) up to 74-78 Gy
- RADIATION
-
prostate radiotherapy
Prostate-only RT (2 Gy fractions, 5 times per week): * Phase 1: prostate + seminal vesicle radiotherapy (46 or 50 Gy according to the center) * Phase 2: prostate-only boost (EBRT) up to 74-78 Gy
Sponsors & Collaborators
- collaborator INDUSTRY
-
UNICANCER
lead OTHER
Principal Investigators
-
Emmanuelle BOMPAS, Doctor · ICO-René Gauducheau - St Herblain
-
Jean-Christophe EYMARD, Doctor · Institut Jean Godinot - Reims
-
Guilhem ROUBAUD, Doctor · Institut Bergonié Bordeaux
-
Philippe BEUZEBOC, Doctor · Institut Curie Paris
-
Aline GUILLOT, Doctor · Institut de Cancérologie Lucien Neuwirth -ST Priest en Jarez
-
Claude EL KOURI, Doctor · Centre Catherine de Sienne - Nantes
-
Frank PRIOU, Doctor · CHD VENDEE - La Roche sur Yon
-
Aude FLECHON, Doctor · CENTRE LEON BERARD - lyon
-
Igor LATORZEFF, Doctor · Clinique Pasteur Toulouse
-
Karim FIZAZI, Professor · Gustave Roussy, Cancer Campus Grand Paris-Paris
-
Jean BERDAH, Doctor · Clinique Ste Marguerite - Hyères
-
Stéphane CULINE, Professor · Hôpital St Louis - Paris
-
Sophie ABADIE-LACOURTOISIE, Doctor · ICO - Paul Papin - Angers
-
Philippe FOURNERET, Doctor · Centre hospitalier de Chambéry - Chambéry
-
Alain GRANDGIRARD, Doctor · Centre hospitalier de Mulhouse - mulhouse
-
Dominique BESSON, Doctor · Clinique Armoricaine de Radiologie - St Brieuc
-
Loïc MOUREY, Doctor · Institut Claudius REGAUD - Toulouse
-
Alain RUFFION, Professor · Centre hospitalier Lyon Sud - Pierre Bénite
-
Tristan MAURINA, Doctor · CHRU Jean Minoz - Besançon
-
Pierre CLAVERE, Professor · CHU Limoges - Limoges
-
Véronique BECKENDORF, Doctor · Institut de Cancérologie de Lorraine
-
Joan Carles, Doctor · Hospital Vall d'Hebron - Barcelone
-
Riccardo Valdagni, Professor · Fondazione IRCCS Istituto Nazionale dei tumori - Milan
-
Philippe RONCHIN, Docteur · Centre Azuréen de Cancérologie - Mougins
-
Eric LECHEVALLIER, Professor · Hôpital de la conception - Marseille
-
Gwenaëlle GRAVIS, Doctor · Institut Paoli Calmettes, Marseille
-
Elise CHAMPEAUX-ORANGE, Doctor · CHR Orléans La Source - Orléans
-
Xavier ARTIGNAN, Doctor · Saint-Gregoire Private Hospital Center
-
Anne DONEUX, Doctor · Clinique Générale d'Annecy
-
Thibaud HAASER, Doctor · Hôpital Haut L'Evèque - Pessac
-
Youssef TAZI, Doctor · STRASBOURG ONCOLOGIE LIBERALE - CLINIQUE SAINTE ANNE - Strasbourg
-
Stéphane OUDARD, Professor · HOPITAL EUROPEEN GEORGES POMPIDOU - Paris
-
Brigitte LAGUERRE, Doctor · CENTRE EUGENE MARQUIS - Rennes
-
Hakim MAHAMMEDI, Doctor · CENTRE JEAN PERRIN - Clermont Ferrand
-
Nadine HOUEDE, Doctor · CHRU de Nîmes Caremeau - Nîmes
-
Gaël DEPLANQUE, Doctor · CH Paris Saint Joseph - Paris
-
Marjorie BACIUCHKA-PALMARO, Doctor · Hôpital Nord Marseille
-
yazid BELKACEMI, Doctor · Hôpital Henri Mondor - Créteil
-
Mostefa BENNAMOUN, Doctor · L'Institut Mutualiste Montsouris-Paris
-
ali HASBINI, Doctor · Clinique Pasteur - Brest
-
Emmanuel GROSS, Doctor · Hôpital privé Clairval - Marseille
-
Bérengère NARCISO RAHARIMANANA, Doctor · CHU de TOURS Hôpital Bretonneau
-
Carole HELISSEY, Doctor · Hôpital d'instruction des armées Bégin - St mandé
-
Marta GUIX, Doctor · Hospital del Mar
-
Begoña PEREZ-VALDERRAMA, Doctor · Hospital Universitario Virgen del Rocio -Sevilla
-
Enrique GALLARDO, Doctor · Parc Tauli Sabadell Hospital Universitari - Sabadell
-
Maria SAEZ, Doctor · H. Virgen de la Victoria - Malaga
-
Montserrat DOMENECH, Doctor · Althaia, Xarxa Universitaria i assistencial de Manresa
-
Sergio VAZQUEZ ESTEVEZ, Doctor · H. Lucus Augusti - Lugo
-
Luis Miguel Anton APARICIO, Doctor · H. Teresa Herrera - Coruna
-
Maria José MENDEZ VIDAL, Doctor · H. Reina Sofia
-
Pilar LOPEZ CRIADO, Doctor · M.D. Anderson Cancer Center
-
Begoña MELLADO GONZALEZ, Doctor · Hospital Clinic of Barcelona
-
Francisco GOMEZ VEIGA, Doctor · University of Salamanca
-
Salvador VILLA i FREIXA, Doctor · ICO Badalona - H.U. Germans Trias
-
Daniel CASTELLANO, Doctor · Hospital Universitario 12 de Octubre
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-12-31
- Primary Completion
- 2025-12-31
- Completion
- 2041-07-31
Countries
- France
Study Locations
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