Etude : GETUG AFU 21 / PEACE 1



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : GETUG AFU 21

Nom : PEACE 1

Traitement : Métastasique ou localement avancé

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 25/09/2017
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Etude prospective de phase III, randomisée, d’évaluation de l’association d’un traitement par déprivation androgénique (+/- docetaxel) avec ou sans radiothérapie avec ou sans abiraterone et prednisone chez les patients présentant un cancer de prostate métastatique hormono-naïf

Spécialité : Organes génitaux masculins
Localisation : C61 - Tumeur maligne de la prostate
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy (+/- docetaxel) with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer

Eligible patients can be randomize in the trial after his consent form has been signed, and after all inclusion and non-inclusion criteria have been checked.

The randomisation will result in the allocation of arm A (ADT), arm B (ADT + Abiraterone), arm C(ADT + radiotherapy) or arm D (ADT + Abiraterone + radiotherapy) in a 1:1:1:1 ratio.

The randomization will be stratified (by minimization) according to:

enrolment center,
performance status (0 vs. 1-2)
disease extent: lymph nodes only vs. bone (with or without lymph nodes) vs. presence of visceral metastases.
CRPC is defined by cancer progression (either a confirmed PSA rise or a radiological progression) with serum testosterone being at castrated levels (<0.50 ng/mL).

When the CRPC stage is reached, castration (either LHRH agonist or LHRH antagonist) will be maintained in all patients. Patients from arm B and D will then stop abiraterone (in selected cases e.g. slow/asymptomatic progressions, the investigator may consider continuing ADT + abirateroneprednisone at CRPC, rather than switching directly to another therapy, for patients included in the abiraterone arms, the use of prednisone at this stage is left to the investigator decision).

Investigators will be free to manage patients reaching CRPC at their discretion (using for example docetaxel, zoledronic acid, denosumab, sipuleucel-T, radium-223, cabazitaxel, etc) according to local uses and guidelines. Abiraterone may be used in arm A and C if abiraterone has become the standard treatment for CRPC when this stage is reached.

Phase : III

Stade : IV

1
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Histologically or cytologically confirmed adenocarcinoma of the prostate,
- Metastatic disease documented by positive bone scan or CTscan or MRI. For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes can be included if they have either:
1) At least one extra-pelvic lymph node ≥ 2 cm or
2) extra-pelvic lymph node (s) ≥ 1 cm if the patients also have at least one pelvic lymph node ≥ 2 cm
- Patients with ECOG ≤ 1 (PS 2 due to bone pain accepted),
- Life expectancy ≥ 6 months,
- Male aged ≥ 18 years old,
- Hemoglobin ≥ 10.0 g/dL,
- Platelet count ≥ 100,000/μL,
- Serum creatinine < 1.5 x ULN or calculated creatinine clearance ≥ 60 mL/min,
- Serum potassium ≥ 4.0 mmol/L,
- Serum bilirubin ≤ 1.5 x ULN (except documented Gilbert's disease); AST and ALT ≤ 2.5 x ULN (≤ 5 ULN in case of liver metastases),
- Patients might have received a maximum of 3 months of ADT before randomization,
- Patients might have received previous radiation therapy directed to bone lesions
- Patients able to take oral medication,
- Patients who have received the information sheet and signed the informed consent form,
- Male patients who are receiving the study treatment and have partners of childbearing potential are advised to use a method of birth control with adequate barrier protection (condoms) as determined to be acceptable by the study doctor during the treatment period and for 4 weeks after the last dose of the study treatment.
- Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,
- Patients with a public or a private health insurance coverage,

Additional criteria for patients receiving docetaxel:
- Patients willing to receive docetaxel
- Neutrophil ≥ 1500 cells/mm3
- Liver function: AST and ALT ≤ 1.5 x ULN; ALP ≤ 2.5 x ULN; Serum bilirubin ≤ 1.5 x ULN.
- Male patients who will receive docetaxel and have partners of childbearing potential and/or pregnant partners are advised to use a method of birth control in addition to an adequate barrier protection (condoms) as determined to be acceptable by the study doctor during the treatment period and for 6 months after the last dose of docetaxel.

Critères de non-inclusion : - Patients with previous local treatment directed to the prostate primary cancer. A previous TURP is allowed,
- Prior cytotoxic chemotherapy or biological therapy for the treatment of prostate cancer,
- Any chronic medical condition requiring a higher dose of corticosteroid than 5mg prednisone/prednisolone twice daily,
- Active infection or other medical condition for which corticosteroid use would be contraindicated,
- Previously treated with ketoconazole for prostate cancer for more than 7 days,
- Prior systemic treatment with an azole drug within 4 weeks of randomization,
- Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg),
- Patients with a history of hypertension except if blood pressure is controlled by anti-hypertensive treatment,
- Active or symptomatic viral hepatitis or chronic liver disease (except Gilbert's disease),
- History of pituitary or adrenal dysfunction,
- Small cell carcinoma of the prostate,
- Clinically known significant heart disease (myocardial infarction, arterial thrombotic events in the past 6 months, severe or unstable angina,NYHA Class II-IV heart disease or cardiac EF < 50% at baseline,
- Atrial Fibrillation, or other cardiac arrhythmia requiring therapy,
- Other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence within 24 months,
- Known allergies, hypersensitivity or intolerance to the study drugs or excipients,
- Administration of an investigational therapeutic within 30 days of D1,
- Patients already included in another therapeutic trial involving an experimental drug,
- Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering participation,
- Individual deprived of liberty or placed under the authority of a tutor.

Additional criteria for patients receiving docetaxel:
- Patients with impaired vision should undergo a prompt and complete ophthalmologic examination. In case of Cystoid Macular Oeadema, the patient should not receive docetaxel.
- Concomitant use of strong CYP3A4 inhibitors ( clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin) 23. Allergy to taxane
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
Promoteur :
Unicancer (IGR)
Type de sponsor : Institutionnel
94800 VILLEJUIF

Coordonnateur :
Alberto BOSSI
alberto.bossi@gustaveroussy.fr
0142114211
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre François BACLESSE - 3 avenue du Général Harris - 14000 CAEN

Investigateur :
Florence JOLY

TEC / ARC / IDE :
Jérémy BOUTROIS
j.boutrois@
baclesse.unicancer.fr

Ouverture de l'essai : CLOS

MAJ : 14/01/2019

Centre investigateur :
Centre de Radiothérapie de la Baie - 1 Avenue du Quesnoy - 50300 ST MARTIN DES CHAMPS

Investigateur :
Nathalie DADOUN

TEC / ARC / IDE :
Sabine MADELAINE
s.madelaine@
centredelabaie.fr

Ouverture de l'essai : CLOS

MAJ : 14/01/2019