Etude : GETUG AFU 23 / PEACE 2

ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.

Acronyme / Nom
Situation thérapeutique
Cadre réglementaire
Présentation de l'étude
Acronyme / Nom : GETUG AFU 23 / PEACE 2

Situation thérapeutique : Néoadjuvant / Adjuvant

Traitement : Chimiothérapie / Thérapie ciblée / Radiothérapie

Cadre réglementaire : RIPH2

Dernière MÀJ : 30/06/2021
CIM10 - Localisation(s)
Informations principales
Titre : Etude de phase III, randomisée, d’évaluation du cabazitaxel et d’une radiothérapie pelvienne chez des patients présentant un cancer de prostate localisé à haut risque de rechute, selon un plan factoriel

Spécialité : Organes génitaux masculins
Localisation : C61 - Tumeur maligne de la prostate
Informations complémentaires
Schéma : Évaluation, selon un plan factoriel 2 x 2, des effets d’un traitement néoadjuvant par cabazitaxel et d’une radiothérapie pelvienne associée à la déprivation androgénique combinée à une radiothérapie prostatique, sur la survie sans progression clinique chez les patients avec un cancer de la prostate localisé, à haut risque de rechute (stricte sélection de patients qui présentent au moins 2 facteurs de haut risque).

Les 4 bras de randomisation sont :
- Bras A : ADT + RT prostatique seule
- Bras B : ADT + RT pelvienne
- Bras C : ADT + CT+ RT prostatique seule
- Bras D : ADT + CT + RT pelvienne

Phase : III

Stade : Localisé à Localement avancé

Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - 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:
1) Gleason score ≥ 8
2) T3 or T4 disease (T3 defined by MRI is acceptable)
3) 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).
- 18 years ≤ Age≤ 75 years
- 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 ULN; AST and ALT ≤ 2.5 x ULN
- Renal function (creatinine clearance using the CKD-EPI formula (Chronic Kidney Disease Epidemiology group) ≥ 60 mL/min).
- 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.
- Patients must be affiliated to a Social Security System or should fulfill the country legislation for clinical trials.
- Patients who have received the information sheet and signed the informed consent form.
- Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures

Critères de non-inclusion : - Patients with other known concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, such as:
1) infection,
2) cardiac disease such as uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within one year, 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 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
- Patients already included in another therapeutic trial involving an experimental drug
- Individual deprived of liberty or placed under the authority of a tutor
- 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
Informations relatives au promoteur
Promoteur :
Unicancer (IGR)
Type de sponsor : Institutionnel

Coordonnateur :
Centre investigateur
Informations relatives aux investigateurs
Centre investigateur :
Centre François BACLESSE - 3 avenue du Général Harris - 14000 CAEN
Apicrypt :

Investigateur :
Pierre-Emmanuel BRACHET


Statut de l'essai : CLOS

MAJ : 30/06/2021