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

Institut Cancerologie de l'Ouest

Status and phase: Completed; Phase 2

Conditions: Prostate Adenocarcinoma

Treatments: Drug: 18-F-MISO

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01898065

2011-004582-32 (EudraCT Number)

RC11-080

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 <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)
• 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

PET imaging, 18 F-miso

Experimental group

Description:

Single Arm study

Treatment:

Drug: 18-F-MISO