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

Phase 2

Completed

• Conditions: Prostate Adenocarcinoma
• Interventions: Drug: 18-F-MISO

• Registration Number: NCT01898065
• Lead Sponsor: Institut Cancerologie de l'Ouest

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2013-07-03
• Study First Submitted QC: 2013-07-10
• Study First Posted: 2013-07-12
• Primary Completion: 2014-11
• Study Completion: 2015-02
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-06
• Last Update Posted: 2015-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET imaging, 18 F-miso	18-F-MISO	Single Arm study

Primary Outcome Measures

Name	Time	Method
To characterize changes in tumor hypoxia (PET with 18F-MISO) during radiation therapy of prostate cancer.	3 to 4 weeks after beginning of radiation therapy	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.

Secondary Outcome Measures

Name	Time	Method
To compare hypoxia imaging (PET with 18F-MISO) with anatomical imaging (PET with 18F-choline) to study the feasibility of a tailored treatment.	before and 3 to 4 weeks after the begining of radiation therapy	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.

Trial Locations

Locations (2)

CHU Poitiers; 🇫🇷 Poitiers, France

ICO Rene Gauducheau; 🇫🇷 St Herblain, France