Overview

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

Status:
Completed
Trial end date:
2015-02-01
Target enrollment:
0
Participant gender:
Male
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Institut Cancerologie de l'Ouest
Collaborators:
Cyclopharma
IASON Gmbh, Feldkirchner strasse 4, 8054 Graz-Seiesberg AUSTRIA
Poitiers University Hospital
Treatments:
Misonidazole
Criteria
Inclusion Criteria:

- histologically proven prostate adenocarcinoma

- Absence of metastases (lymph node or bone)

- One or more tumor nodules seen on MRI and PET Choline.

- Intermediate Risk : Gleason 7 and PSA (prostate specific antigen)<20 ng / ml, T or Gleason 6 and PSA 10-20 ng / ml, T
- No concomitant hormonal treatment. (NB: the introduction of hormone therapy during
radiotherapy before the second 18F-MISO is a criterion to study exit)

- Indication of radiotherapy up to a total dose> 70 Gy and 2 Gy/day fractions

- Signed Informed consent

- Social Insurance

Exclusion Criteria:

- Age < 18 years old

- Patient protected by law