Etude : GETUG AFU 26 / PRESTO



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
Traitement
Cadre réglementaire
MÀJ
Présentation de l'étude
Acronyme / Nom : GETUG AFU 26 / PRESTO

Situation thérapeutique : Métastatique ou localement avancé

Traitement : Radiothérapie

Cadre réglementaire : RIPH1

Dernière MÀJ : 29/11/2021
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Etude randomisée contrôlée de phase III évaluant l'efficacité de la radiothérapie stéréotaxique ablative tumorale chez les patients atteints de cancer de prostate oligométastatique hormonosensible

Spécialité : Organes génitaux masculins
Localisation : C61 - Tumeur maligne de la prostate
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : INDICATION: Oligometastatic hormone-sensitive prostate cancer patients.
METHODOLOGY: Open label, double arm, randomized 1:1, multicenter phase III study.

PRIMARY OBJECTIVE: To assess the efficacy of ablative radiotherapy (SBRT applied to all oligometastases) administered to all gross tumor sites (metastases and prostate if applicable), in oligometastatic hormone-sensitive prostate cancer patients.

STUDY ARMS:
- Experimental: Arm A - Standard of care + Stereotactic Body Radiotherapy to oligometastases*

- Active Comparator: Arm B - Standard of care

Definition of standard of care (prior to randomization): Radiotherapy to the prostate in de novo metastatic patients Long-term Androgen Deprivation Therapy (ADT) with or without intermittent treatment. Additional therapy with abiraterone acetate or docetaxel following tumor board meeting.

SBRT is delivered using the following regimen: 30 Grays (10 Gy x 3 fractions) for axial and appendicular bones and lymph node metastases if present. In case the dose cannot be safely delivered while maintaining a safe dose to the organs at risk, an alternate regimen (35 Gy in 5 fractions of 7 Gy) can be used.

In de novo metastatic patients: Prostate and seminal vesicle external beam radiotherapy using either 74-80 Gy with conventional fractionation (in fractions of 2 Gy) or using a hypofractionated regimen delivering 60 Gy (20 fractions of 3 Gy).

Phase : III

Stade : Métastatique

1
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 : - Histologically proven adenocarcinoma of the prostate (any T stage, Gleason score or prostate-specific antigen (PSA) level)
- Defined as M1 based on the presence of at least one bone metastasis
- Diagnostic workup including functional imaging (F- or C-Choline-PET/CT, Prostate Specific Membrane Antigen (PSMA) PET/CT or whole body MRI) and Computed Tomography of Thorax, Abdomen and Pelvis (CT-TAP) done before the start of hormonal therapy
- With up to 5 asymptomatic or paucisymptomatic metastatic sites including at least one bone lesion with or without nodal metastases. Are counted as a separate metastasis each bone lesion and each node located outside the true pelvis with a small diameter of 1 cm or greater or with univocal abnormal function imaging (PET-Scan hyperfixation or hypersignal in whole body MRI)
- Patients with a previous prostatectomy or radiotherapy to the prostate and/or pelvic lymph nodes are eligible provided they have no active disease within the irradiated areas, based on functional imaging findings
- Age ≥18 years
- Eastern Cooperative Oncology Group (ECOG) ≤2
- Suitable for long term anti androgen therapy
- Patient not suitable for docetaxel or abiraterone can be included
- Patient that have started long term hormonal therapy are eligible if hormonal therapy has been initiated less than 2 months before randomization
- Patients must agree to use adequate contraception methods for the duration of study treatment and for 6 months after completing treatment
- Patient must have received the information sheet and signed the consent form
- Patients must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures
- Patient must be affiliated to the social security system.

Critères de non-inclusion : - Patient with more than 5 metastatic sites
- Patient with metastatic sites other than bone or lymph nodes (lung, brain, or liver metastases)
- Metastases not amenable to stereotactic body radiotherapy by multidisciplinary meeting (e.g. gross epidural involvement, involvement of three contiguous vertebral bodies, major soft tissue involvement, and previous radiation treatment)
- Metastases requiring immediate treatment due to significant pain (use of opioid medication), or at risk of fracture or neurological deficit
- Castrate testosterone level <50 ng/dL or ≤0.50 ng/mL or 1.73 nmol/L prior use of ADT
- Prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for ≥5 years
- Contra-indication to MRI (needed for spinal SBRT)
- Persons deprived of their liberty or under protective custody or guardianship;
- Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons
- Participation in another therapeutic trial within 30 days prior to randomization.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT04115007
Promoteur :
Unicancer
Type de sponsor : Institutionnel
3, avenue du Général Harris
14000 CAEN

Coordonnateur :
Professeur Pierre BLANCHARD
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Oscar Lambret - 3 Rue Frédéric Combemale - 59000 LILLE

Investigateur :
Docteur David PASQUIER

TEC / ARC / IDE :
Unité Intégrée de Recherche Clinique
investigation@
o-lambret.fr
03.20.29.59.35

Statut de l'essai : OUVERT

MAJ : 28/09/2021