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

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Hypoxia by PET With 18-FluoroMisonidazole During Radiation Therapy of Prostate Cancer

Conditions
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Prostate Adenocarcinoma

Intervention / Treatment
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* Drug: 18-F-MISO


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PET imaging, 18 F-miso<br>Single Arm study | Drug: 18-F-MISO<br>* PET scan with the 18 Fluoro Misonidazole<br>* Other names: 18 Fluoro Misonidazole;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize changes in tumor hypoxia (PET with 18F-MISO) during radiation therapy of prostate cancer. | First PET-scan with 18-F-Miso done before radiation Second PET-scan with 18-F-Miso done 3 to 4 weeks after the beginning of radiation therapy. | 3 to 4 weeks after beginning of radiation therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare hypoxia imaging (PET with 18F-MISO) with anatomical imaging (PET with 18F-choline) to study the feasibility of a tailored treatment. | Images obtained with PET Choline and MRI (anatomical location) will be merge with images obtained by 18F-MISO PET to search hypoxia on these anatomical areas. | before and 3 to 4 weeks after the begining of radiation therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypoxia, radiotherapy, PET with 18-F-MISO, MRI