Etude : DEMETER /



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
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : DEMETER

Nom :

Traitement :

Type d'étude : Qualité de vie / Observationnelle

Dernière MÀJ : 24/01/2020
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Interest of Trimodality PET-CT Choline MRI Before Radiotherapy in High Risk Prostate Cancer

Spécialité : Organes génitaux masculins
Localisation : C61 - Tumeur maligne de la prostate
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : The initial staging of locally advanced prostate cancer is made with Computed Tomography scan (CT), Magnetic Resonance Imaging (MRI), and bone scan (BS).

For this type of cancer, reference treatment is radiotherapy combined with hormone therapy.

The added value of MRI in the delineation of volumes for radiotherapy is known, especially for the definition of extra-prostatic extensions and prostatic apex. However, its regular use is difficult. Indeed, acquisition of Magnetic Resonance Imaging parameters for diagnostic are not adapted to be fused with the planning Computed Tomography.

The literature shows that Positron Emission Tomography-Computed Tomography with Fluorocholine is better in terms of diagnostic performance compared to bone scan for bone metastases and to pelvic Magnetic Resonance Imaging for nodal extension.

It would therefore improve staging for these patients with a high risk of locoregional and metastatic invasion even if its use is currently not recommended in the initial staging.

Thanks to Magnetic Resonance Imaging acquisition parameters adapted to Radiotherapy and additional functional information, an acquisition in tri-modality Positron Emission Tomography/computed Tomography/ Magnetic Resonance Imaging could have an impact on the volumes definition for radiotherapy or even on the therapeutic strategy.

The aim of the study is to evaluate the volume modifications obtained on the trimodality evaluation, compared to the standard initial staging (geometric comparison).

In addition, it would be a preliminary study for a project using Prostate-specific membrane antigen (PSMA) in trimodality, and / or for a therapeutic interventional study.

Phase : NA

Stade : NA

NA
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 : More than 18 years
prostate cancer : High risk (according to D'Amico Classification)
and/or Node positive on MRI
T2c-T3 on MRI
with staging assessment
will receive radiotherapy

Critères de non-inclusion : second cancer
contraindication to MRI
participation in an another therapeutic trial
patients under guardianship or curatorship
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03734757
Promoteur :
Centre Henri Becquerel
Type de sponsor : Institutionnel
1, rue d'Amiens
76000 ROUEN

Coordonnateur :
Dr Anne-Charlotte BOUYEURE
anne-charlotte.bouyeure@chb.unicancer.fr
+33232083030
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Henri Becquerel - Rue d'Amiens CS 11516 - Cedex 1 - 76000 ROUEN

Investigateur :
Dr Anne-Charlotte BOUYEURE

TEC / ARC / IDE :
Olivier RASTELLI
olivier.rastelli@
chb.unicancer.fr
02.32.08.29.00

Statut de l'essai : OUVERT

MAJ : 24/01/2020