Clinical Trial · NCT01898065

Evaluation of Hypoxia by PET With F-Miso in Radiation Therapy of Prostate Cancer

Overview

With functional imaging development, it becomes possible to increase radiation dose to radioresistant areas (located inside tumor volume) using radiotherapy dose-painting. This strategy is particularly suitable for prostate cancer where tumor hypoxia plays a major role in the resistance of these tumors to radiation. In order to develop intratumoral hypoxia targeting by radiotherapy dose-painting areas, we should characterize changes in hypoxia before treatment and during radiotherapy. * If hypoxia does not change during radiotherapy, radiotherapy dose-painting strategy by an "integrated" boost is performed. * If hypoxia varied (increasing or incomplete regression), a "final" boost strategy of radiotherapy dose-painting(IMRT, stereotactic brachytherapy or high dose rate) after a first fractionated IMRT could be considered. This study should show that PET imaging with fluoromisonidazole (18F-MISO) is an available tool to physicians in assessing tumor hypoxia.

Sponsor

Institut Cancerologie de l'Ouest

Phase

Phase 2

Contacts

SUPIOT Stéphane, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01898065

Drug / Compound

fluoromisonidazole

Isotope(s):

Target(s):

Hypoxia

Ligand Class: Small Molecules

Eligibility

Inclusion

Intermediate Risk : Gleason 7 and PSA (prostate specific antigen)\<20 ng / ml, T \<T2c or Gleason 6 and PSA 10-20 ng / ml, T \<T2c
No concomitant hormonal treatment. (NB: the introduction of hormone therapy during radiotherapy before the second 18F-MISO is a criterion to study exit)
Social Insurance
Absence of metastases (lymph node or bone)
Indication of radiotherapy up to a total dose\> 70 Gy and 2 Gy/day fractions
histologically proven prostate adenocarcinoma
One or more tumor nodules seen on MRI and PET Choline.

Exclusion

Patient protected by law