A Phase III of Cabazitaxel and Pelvic Radiotherapy in Localized Prostate Cancer and High-risk Features of Relapse

NCT01952223 | Active Not Recruiting Phase 3 DMC

• 2 other identifiers: GETUG-AFU 23 - UC-0160/12022012-000566-38
• Study Type: interventional
• Target: 761
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

adenocarcinoma; prostate; relapse; Radiotherapy; Androgen Deprivation Therapy; Cabazitaxel

Outcome Measures

Primary Outcomes (1)

• progression free survival

  10 years

Secondary Outcomes (11)

• prostate-specific antigen response at 3 months

  10 years

• biochemical progression-free survival

  10 years

• metastases-free survival

  10 years

• local relapse-free survival

  10 years

• overall survival

  10 years

Study Arms (4)

ADT + pelvic RT

EXPERIMENTAL

ADT for a total duration of 3 years i.e. luteinizing hormone-releasing hormone (LHRH) agonist or LHRH antagonist +/-Peripheral anti-androgen Pelvic RT (by IMRT or IGRT protocol): * 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: Pelvic radiotherapy

ADT + Cabazitaxel + prostate RT

EXPERIMENTAL

ADT Cabazitaxel: 4 CT cycles Prostate-only RT (IMRT or IGRT): * 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

Drug: Cabazitaxel; Radiation: prostate radiotherapy

ADT + cabazitaxel + pelvic RT

EXPERIMENTAL

ADT Cabazitaxel: 4 CT cycles Pelvic RT (IMRT or IGRT): * 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

Drug: Cabazitaxel; Radiation: Pelvic radiotherapy

ADT + prostate radiotherapy

ACTIVE COMPARATOR

ADT for a total duration of 3 years: LHRH agonist or LHRH antagonist +/- anti-androgen Prostate-only RT (IMRt or IGRT): * 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

Radiation: prostate radiotherapy

Interventions

Cabazitaxel DRUG

Cabazitaxel administered at 25 mg/m² as a 1 hour intravenous infusion every 3 weeks (1 cycle = 21 days) for 4 cycles

Also known as: jevtana

ADT + Cabazitaxel + prostate RT; ADT + cabazitaxel + pelvic RT

Pelvic radiotherapy RADIATION

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

ADT + cabazitaxel + pelvic RT; ADT + pelvic RT

prostate radiotherapy RADIATION

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

ADT + Cabazitaxel + prostate RT; ADT + prostate radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any T histologically confirmed adenocarcinoma of the prostate
• No clinically or radiologically suspected metastases, including no enlarged pelvic lymph nodes (\> 1 cm in small diameter)
• Gleason score ≥ 6
• Meets at least 2 of the following criteria for high-risk:
• Gleason score ≥ 8
• T3 or T4 disease (T3 defined by MRI is acceptable)
• Prostate-specific antigen equal or greater than 20 ng/mL
• No prior treatment for prostate cancer except lymph node dissection (patients with pN- and pN+ disease can be accrued) or ADT (started up to 6 weeks before randomization).
• years ≤ Age ≤ 75 years
• Eastern Cooperative Oncology Group (ECOG) 0-1 performance status
• Expected life expectancy of more than 10 years
• Absolute neutrophil count ≥ 1.5 x 10⁹/L
• Platelets ≥ 100 x 10⁹/L
• Hb ≥ 9.0 g/dL
• Hepatic function: serum bilirubin ≤ 1 upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN

You may not qualify if:

• Patients with other known concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, such as:
• infection,
• cardiac disease such as uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within one year, left ventricular ejection fraction (LVEF) \> grade 2,
• uncontrolled diabetes mellitus,
• current active hepatic or biliary disease (with exception of subjects with Gilbert's syndrome, asymptomatic gallstones, stable chronic liver disease per investigator assessment),
• renal disease,
• active GI tract ulceration, malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with active, uncontrolled ulcerative colitis are also excluded,
• known severely impaired lung function (spirometry and diffusing capacity of the lungs for carbon monoxide (DLCO) 70% or less of normal and O2 saturation of 88% or less at rest on room air).
• Other prior malignancy within the last 5 years, except basal cell skin cancer
• Physical or psychological condition that would preclude study compliance
• Hypersensitivity to cabazitaxel (hypersensitivity reaction ≥grade 3), to other taxanes, or to any excipients of the formulation including polysorbate 80
• Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
• Patients who received any other investigational drugs within the 30 days prior to the start of cabazitaxel.
• Previous pelvic irradiation that make prostatic irradiation impossible
• Severe GI disorders precluding pelvic irradiation

Sponsors & Collaborators

• UNICANCER: lead
• Sanofi: collaborator

Study Sites (1)

Institut Gustave Roussy

Villejuif, F-94805, France

Location

MeSH Terms

Conditions

Adenocarcinoma; Recurrence

Interventions

cabazitaxel

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emmanuelle BOMPAS, Doctor

  ICO-René Gauducheau - St Herblain

  PRINCIPAL INVESTIGATOR

• Jean-Christophe EYMARD, Doctor

  Institut Jean Godinot - Reims

  PRINCIPAL INVESTIGATOR

• Guilhem ROUBAUD, Doctor

  Institut Bergonié Bordeaux

  PRINCIPAL INVESTIGATOR

• Philippe BEUZEBOC, Doctor

  Institut Curie Paris

  PRINCIPAL INVESTIGATOR

• Aline GUILLOT, Doctor

  Institut de Cancérologie Lucien Neuwirth -ST Priest en Jarez

  PRINCIPAL INVESTIGATOR

• Claude EL KOURI, Doctor

  Centre Catherine de Sienne - Nantes

  PRINCIPAL INVESTIGATOR

• Frank PRIOU, Doctor

  CHD VENDEE - La Roche sur Yon

  PRINCIPAL INVESTIGATOR

• Aude FLECHON, Doctor

  CENTRE LEON BERARD - lyon

  PRINCIPAL INVESTIGATOR

• Igor LATORZEFF, Doctor

  Clinique Pasteur Toulouse

  PRINCIPAL INVESTIGATOR

• Karim FIZAZI, Professor

  Gustave Roussy, Cancer Campus Grand Paris-Paris

  PRINCIPAL INVESTIGATOR

• Jean BERDAH, Doctor

  Clinique Ste Marguerite - Hyères

  PRINCIPAL INVESTIGATOR

• Stéphane CULINE, Professor

  Hôpital St Louis - Paris

  PRINCIPAL INVESTIGATOR

• Sophie ABADIE-LACOURTOISIE, Doctor

  ICO - Paul Papin - Angers

  PRINCIPAL INVESTIGATOR

• Philippe FOURNERET, Doctor

  Centre hospitalier de Chambéry - Chambéry

  PRINCIPAL INVESTIGATOR

• Alain GRANDGIRARD, Doctor

  Centre hospitalier de Mulhouse - mulhouse

  PRINCIPAL INVESTIGATOR

• Dominique BESSON, Doctor

  Clinique Armoricaine de Radiologie - St Brieuc

  PRINCIPAL INVESTIGATOR

• Loïc MOUREY, Doctor

  Institut Claudius REGAUD - Toulouse

  PRINCIPAL INVESTIGATOR

• Alain RUFFION, Professor

  Centre hospitalier Lyon Sud - Pierre Bénite

  PRINCIPAL INVESTIGATOR

• Tristan MAURINA, Doctor

  CHRU Jean Minoz - Besançon

  PRINCIPAL INVESTIGATOR

• Pierre CLAVERE, Professor

  CHU Limoges - Limoges

  PRINCIPAL INVESTIGATOR

• Véronique BECKENDORF, Doctor

  Institut de Cancérologie de Lorraine

  PRINCIPAL INVESTIGATOR

• Joan Carles, Doctor

  Hospital Vall d'Hebron - Barcelone

  PRINCIPAL INVESTIGATOR

• Riccardo Valdagni, Professor

  Fondazione IRCCS Istituto Nazionale dei tumori - Milan

  PRINCIPAL INVESTIGATOR

• Philippe RONCHIN, Docteur

  Centre Azuréen de Cancérologie - Mougins

  PRINCIPAL INVESTIGATOR

• Eric LECHEVALLIER, Professor

  Hôpital de la conception - Marseille

  PRINCIPAL INVESTIGATOR

• Gwenaëlle GRAVIS, Doctor

  Institut Paoli Calmettes, Marseille

  PRINCIPAL INVESTIGATOR

• Elise CHAMPEAUX-ORANGE, Doctor

  CHR Orléans La Source - Orléans

  PRINCIPAL INVESTIGATOR

• Xavier ARTIGNAN, Doctor

  Saint-Gregoire Private Hospital Center

  PRINCIPAL INVESTIGATOR

• Anne DONEUX, Doctor

  Clinique Générale d'Annecy

  PRINCIPAL INVESTIGATOR

• Thibaud HAASER, Doctor

  Hôpital Haut L'Evèque - Pessac

  PRINCIPAL INVESTIGATOR

• Youssef TAZI, Doctor

  STRASBOURG ONCOLOGIE LIBERALE - CLINIQUE SAINTE ANNE - Strasbourg

  PRINCIPAL INVESTIGATOR

• Stéphane OUDARD, Professor

  HOPITAL EUROPEEN GEORGES POMPIDOU - Paris

  PRINCIPAL INVESTIGATOR

• Brigitte LAGUERRE, Doctor

  CENTRE EUGENE MARQUIS - Rennes

  PRINCIPAL INVESTIGATOR

• Hakim MAHAMMEDI, Doctor

  CENTRE JEAN PERRIN - Clermont Ferrand

  PRINCIPAL INVESTIGATOR

• Nadine HOUEDE, Doctor

  CHRU de Nîmes Caremeau - Nîmes

  PRINCIPAL INVESTIGATOR

• Gaël DEPLANQUE, Doctor

  CH Paris Saint Joseph - Paris

  PRINCIPAL INVESTIGATOR

• Marjorie BACIUCHKA-PALMARO, Doctor

  Hôpital Nord Marseille

  PRINCIPAL INVESTIGATOR

• yazid BELKACEMI, Doctor

  Hôpital Henri Mondor - Créteil

  PRINCIPAL INVESTIGATOR

• Mostefa BENNAMOUN, Doctor

  L'Institut Mutualiste Montsouris-Paris

  PRINCIPAL INVESTIGATOR

• ali HASBINI, Doctor

  Clinique Pasteur - Brest

  PRINCIPAL INVESTIGATOR

• Emmanuel GROSS, Doctor

  Hôpital privé Clairval - Marseille

  PRINCIPAL INVESTIGATOR

• Bérengère NARCISO RAHARIMANANA, Doctor

  CHU de TOURS Hôpital Bretonneau

  PRINCIPAL INVESTIGATOR

• Carole HELISSEY, Doctor

  Hôpital d'instruction des armées Bégin - St mandé

  PRINCIPAL INVESTIGATOR

• Marta GUIX, Doctor

  Hospital del Mar

  PRINCIPAL INVESTIGATOR

• Begoña PEREZ-VALDERRAMA, Doctor

  Hospital Universitario Virgen del Rocio -Sevilla

  PRINCIPAL INVESTIGATOR

• Enrique GALLARDO, Doctor

  Parc Tauli Sabadell Hospital Universitari - Sabadell

  PRINCIPAL INVESTIGATOR

• Maria SAEZ, Doctor

  H. Virgen de la Victoria - Malaga

  PRINCIPAL INVESTIGATOR

• Montserrat DOMENECH, Doctor

  Althaia, Xarxa Universitaria i assistencial de Manresa

  PRINCIPAL INVESTIGATOR

• Sergio VAZQUEZ ESTEVEZ, Doctor

  H. Lucus Augusti - Lugo

  PRINCIPAL INVESTIGATOR

• Luis Miguel Anton APARICIO, Doctor

  H. Teresa Herrera - Coruna

  PRINCIPAL INVESTIGATOR

• Maria José MENDEZ VIDAL, Doctor

  H. Reina Sofia

  PRINCIPAL INVESTIGATOR

• Pilar LOPEZ CRIADO, Doctor

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

• Begoña MELLADO GONZALEZ, Doctor

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

• Francisco GOMEZ VEIGA, Doctor

  University of Salamanca

  PRINCIPAL INVESTIGATOR

• Salvador VILLA i FREIXA, Doctor

  ICO Badalona - H.U. Germans Trias

  PRINCIPAL INVESTIGATOR

• Daniel CASTELLANO, Doctor

  Hospital Universitario 12 de Octubre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: September 27, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2041
• Last Updated: July 30, 2025

Record last verified: 2025-06

Locations

FR (1)