A Phase III of Cabazitaxel and Pelvic Radiotherapy in Localized Prostate Cancer and High-risk Features of Relapse
NCT ID: NCT01952223
Last Updated: 2025-07-30
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
761 participants
INTERVENTIONAL
2013-12-31
2041-07-31
Brief Summary
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Detailed Description
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Randomization will be performed according a 1:1:1:1 ratio. The randomization will be stratified (by minimization) according to the number of risk factors (2 vs.3), disease extent (pN- vs. pN+ vs. pNx) and the site.
The minimization will be defined with a similar weight for all 3 stratification factors and a probability of assigning the treatment that minimize the imbalance equal to 80%.
The main analysis of progression-free survival (PFS) will be event driven (\> 247 events). It will likely be performed when the median follow-up is approximately 6 years, i.e. 4 years after the inclusion of the last patient (assuming an accrual of 4 years).
A long-term analysis (allowing for robust PFS and overall survival (OS) data) will also be performed when the follow-up is approximately 10 years. Its exact timing will be discussed with the steering committee and the IDMC.
An interim analysis of the primary endpoint is planned. This interim analysis will be performed at a 0.001 level (Peto) after 50% of the events i.e. 125 have occurred.
For each comparison (CT comparison and pelvic RT comparison) the two PFS curves will be compared using the adjusted logrank test (bilateral test): adjusted logrank on pelvic RT for the CT comparison and on CT for the pelvic RT comparison. A multivariate analysis using the Cox model will also be used.
An Independent Data Monitoring Committee (IDMC) composed of international experts (at least 2 physicians and 1 statistician) will be selected.
For safety purpose, the IDMC will meet after the inclusion of 20 patients (and then again after accrual of 50 patients) in the cabazitaxel and pelvic radiotherapy arm, to assess tolerance, (i.e. after the inclusion of approximately 80 and then 200 patients in the trial). Depending on the results of this feasibility phase and of any new relevant clinical results in such a population, the remaining patients (n=848) will be enrolled.
During this second phase, the IDMC will then meet every two years approximately during accrual to carefully assess accrual rate and toxicity and examine the efficacy interim analysis results in the light of the results of similar trials.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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ADT + pelvic RT
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
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
ADT + Cabazitaxel + prostate RT
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
Cabazitaxel
Cabazitaxel administered at 25 mg/m² as a 1 hour intravenous infusion every 3 weeks (1 cycle = 21 days) for 4 cycles
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
ADT + cabazitaxel + pelvic RT
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
Cabazitaxel
Cabazitaxel administered at 25 mg/m² as a 1 hour intravenous infusion every 3 weeks (1 cycle = 21 days) for 4 cycles
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
ADT + prostate radiotherapy
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
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
Interventions
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Cabazitaxel
Cabazitaxel administered at 25 mg/m² as a 1 hour intravenous infusion every 3 weeks (1 cycle = 21 days) for 4 cycles
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. No clinically or radiologically suspected metastases, including no enlarged pelvic lymph nodes (\> 1 cm in small diameter)
3. Gleason score ≥ 6
4. 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
5. 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).
6. 18 years ≤ Age ≤ 75 years
7. Eastern Cooperative Oncology Group (ECOG) 0-1 performance status
8. Expected life expectancy of more than 10 years
9. Absolute neutrophil count ≥ 1.5 x 10⁹/L
10. Platelets ≥ 100 x 10⁹/L
11. Hb ≥ 9.0 g/dL
12. Hepatic function: serum bilirubin ≤ 1 upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
13. Renal function (creatinine clearance using the Chronic Kidney Disease Epidemiology group (CKD-EPI) formula ≥ 60 mL/min).
14. Potentially reproductive patients must agree to use an effective contraceptive method while on treatment and for 6 months after the final dose of investigational product.
15. Patients must be affiliated to a Social Security System or should fulfill the country legislation for clinical trials.
16. Patients who have received the information sheet and signed the informed consent form.
17. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
Exclusion Criteria
1. infection,
2. 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,
3. uncontrolled diabetes mellitus,
4. current active hepatic or biliary disease (with exception of subjects with Gilbert's syndrome, asymptomatic gallstones, stable chronic liver disease per investigator assessment),
5. renal disease,
6. 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,
7. 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).
2. Other prior malignancy within the last 5 years, except basal cell skin cancer
3. Physical or psychological condition that would preclude study compliance
4. Hypersensitivity to cabazitaxel (hypersensitivity reaction ≥grade 3), to other taxanes, or to any excipients of the formulation including polysorbate 80
5. 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.
6. Patients who received any other investigational drugs within the 30 days prior to the start of cabazitaxel.
7. Previous pelvic irradiation that make prostatic irradiation impossible
8. Severe GI disorders precluding pelvic irradiation
9. Patients already included in another therapeutic trial involving an experimental drug
10. Individual deprived of liberty or placed under the authority of a tutor.
11. Concomitant prohibited treatment. Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (see Appendix 6). A one week wash-out period is necessary for patients who are already on these treatments
18 Years
75 Years
MALE
No
Sponsors
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Sanofi
INDUSTRY
UNICANCER
OTHER
Responsible Party
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Principal Investigators
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Emmanuelle BOMPAS, Doctor
Role: PRINCIPAL_INVESTIGATOR
ICO-René Gauducheau - St Herblain
Jean-Christophe EYMARD, Doctor
Role: PRINCIPAL_INVESTIGATOR
Institut Jean Godinot - Reims
Guilhem ROUBAUD, Doctor
Role: PRINCIPAL_INVESTIGATOR
Institut Bergonié Bordeaux
Philippe BEUZEBOC, Doctor
Role: PRINCIPAL_INVESTIGATOR
Institut Curie Paris
Aline GUILLOT, Doctor
Role: PRINCIPAL_INVESTIGATOR
Institut de Cancérologie Lucien Neuwirth -ST Priest en Jarez
Claude EL KOURI, Doctor
Role: PRINCIPAL_INVESTIGATOR
Centre Catherine de Sienne - Nantes
Frank PRIOU, Doctor
Role: PRINCIPAL_INVESTIGATOR
CHD VENDEE - La Roche sur Yon
Aude FLECHON, Doctor
Role: PRINCIPAL_INVESTIGATOR
CENTRE LEON BERARD - lyon
Igor LATORZEFF, Doctor
Role: PRINCIPAL_INVESTIGATOR
Clinique Pasteur Toulouse
Karim FIZAZI, Professor
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy, Cancer Campus Grand Paris-Paris
Jean BERDAH, Doctor
Role: PRINCIPAL_INVESTIGATOR
Clinique Ste Marguerite - Hyères
Stéphane CULINE, Professor
Role: PRINCIPAL_INVESTIGATOR
Hôpital St Louis - Paris
Sophie ABADIE-LACOURTOISIE, Doctor
Role: PRINCIPAL_INVESTIGATOR
ICO - Paul Papin - Angers
Philippe FOURNERET, Doctor
Role: PRINCIPAL_INVESTIGATOR
Centre hospitalier de Chambéry - Chambéry
Alain GRANDGIRARD, Doctor
Role: PRINCIPAL_INVESTIGATOR
Centre hospitalier de Mulhouse - mulhouse
Dominique BESSON, Doctor
Role: PRINCIPAL_INVESTIGATOR
Clinique Armoricaine de Radiologie - St Brieuc
Loïc MOUREY, Doctor
Role: PRINCIPAL_INVESTIGATOR
Institut Claudius REGAUD - Toulouse
Alain RUFFION, Professor
Role: PRINCIPAL_INVESTIGATOR
Centre hospitalier Lyon Sud - Pierre Bénite
Tristan MAURINA, Doctor
Role: PRINCIPAL_INVESTIGATOR
CHRU Jean Minoz - Besançon
Pierre CLAVERE, Professor
Role: PRINCIPAL_INVESTIGATOR
CHU Limoges - Limoges
Véronique BECKENDORF, Doctor
Role: PRINCIPAL_INVESTIGATOR
Institut de Cancérologie de Lorraine
Joan Carles, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hospital Vall d'Hebron - Barcelone
Riccardo Valdagni, Professor
Role: PRINCIPAL_INVESTIGATOR
Fondazione IRCCS Istituto Nazionale dei tumori - Milan
Philippe RONCHIN, Docteur
Role: PRINCIPAL_INVESTIGATOR
Centre Azuréen de Cancérologie - Mougins
Eric LECHEVALLIER, Professor
Role: PRINCIPAL_INVESTIGATOR
Hôpital de la conception - Marseille
Gwenaëlle GRAVIS, Doctor
Role: PRINCIPAL_INVESTIGATOR
Institut Paoli Calmettes, Marseille
Elise CHAMPEAUX-ORANGE, Doctor
Role: PRINCIPAL_INVESTIGATOR
CHR Orléans La Source - Orléans
Xavier ARTIGNAN, Doctor
Role: PRINCIPAL_INVESTIGATOR
Saint-Gregoire Private Hospital Center
Anne DONEUX, Doctor
Role: PRINCIPAL_INVESTIGATOR
Clinique Générale d'Annecy
Thibaud HAASER, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hôpital Haut L'Evèque - Pessac
Youssef TAZI, Doctor
Role: PRINCIPAL_INVESTIGATOR
STRASBOURG ONCOLOGIE LIBERALE - CLINIQUE SAINTE ANNE - Strasbourg
Stéphane OUDARD, Professor
Role: PRINCIPAL_INVESTIGATOR
HOPITAL EUROPEEN GEORGES POMPIDOU - Paris
Brigitte LAGUERRE, Doctor
Role: PRINCIPAL_INVESTIGATOR
CENTRE EUGENE MARQUIS - Rennes
Hakim MAHAMMEDI, Doctor
Role: PRINCIPAL_INVESTIGATOR
CENTRE JEAN PERRIN - Clermont Ferrand
Nadine HOUEDE, Doctor
Role: PRINCIPAL_INVESTIGATOR
CHRU de Nîmes Caremeau - Nîmes
Gaël DEPLANQUE, Doctor
Role: PRINCIPAL_INVESTIGATOR
CH Paris Saint Joseph - Paris
Marjorie BACIUCHKA-PALMARO, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hôpital Nord Marseille
yazid BELKACEMI, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hôpital Henri Mondor - Créteil
Mostefa BENNAMOUN, Doctor
Role: PRINCIPAL_INVESTIGATOR
L'Institut Mutualiste Montsouris-Paris
ali HASBINI, Doctor
Role: PRINCIPAL_INVESTIGATOR
Clinique Pasteur - Brest
Emmanuel GROSS, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hôpital privé Clairval - Marseille
Bérengère NARCISO RAHARIMANANA, Doctor
Role: PRINCIPAL_INVESTIGATOR
CHU de TOURS Hôpital Bretonneau
Carole HELISSEY, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hôpital d'instruction des armées Bégin - St mandé
Marta GUIX, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hospital del Mar
Begoña PEREZ-VALDERRAMA, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Virgen del Rocio -Sevilla
Enrique GALLARDO, Doctor
Role: PRINCIPAL_INVESTIGATOR
Parc Tauli Sabadell Hospital Universitari - Sabadell
Maria SAEZ, Doctor
Role: PRINCIPAL_INVESTIGATOR
H. Virgen de la Victoria - Malaga
Montserrat DOMENECH, Doctor
Role: PRINCIPAL_INVESTIGATOR
Althaia, Xarxa Universitaria i assistencial de Manresa
Sergio VAZQUEZ ESTEVEZ, Doctor
Role: PRINCIPAL_INVESTIGATOR
H. Lucus Augusti - Lugo
Luis Miguel Anton APARICIO, Doctor
Role: PRINCIPAL_INVESTIGATOR
H. Teresa Herrera - Coruna
Maria José MENDEZ VIDAL, Doctor
Role: PRINCIPAL_INVESTIGATOR
H. Reina Sofia
Pilar LOPEZ CRIADO, Doctor
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Begoña MELLADO GONZALEZ, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic of Barcelona
Francisco GOMEZ VEIGA, Doctor
Role: PRINCIPAL_INVESTIGATOR
University of Salamanca
Salvador VILLA i FREIXA, Doctor
Role: PRINCIPAL_INVESTIGATOR
ICO Badalona - H.U. Germans Trias
Daniel CASTELLANO, Doctor
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario 12 de Octubre
Locations
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Institut Gustave Roussy
Villejuif, , France
Countries
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Other Identifiers
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2012-000566-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GETUG-AFU 23 - UC-0160/1202
Identifier Type: -
Identifier Source: org_study_id
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