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

November 6, 2015 updated by: Institut Cancerologie de l'Ouest

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Poitiers, France, 86000
        • CHU Poitiers
      • St Herblain, France, 44805
        • Ico Rene Gauducheau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PET imaging, 18 F-miso
Single Arm study
Drug: 18-F-MISO
PET scan with the 18 Fluoro Misonidazole
Other Names:
  • 18 Fluoro Misonidazole

What is the study measuring?

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.
Time Frame: 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.
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.
Time Frame: 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.
before and 3 to 4 weeks after the begining of radiation therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Cancerologie de l'Ouest

Collaborators

Poitiers University Hospital
IASON Gmbh, Feldkirchner strasse 4, 8054 Graz-Seiesberg AUSTRIA
Cyclopharma

Investigators

  • Principal Investigator: SUPIOT Stéphane, MD, Ico Rene Gauducheau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

July 3, 2013

First Submitted That Met QC Criteria

July 10, 2013

First Posted (Estimate)

July 12, 2013

Study Record Updates

Last Update Posted (Estimate)

November 9, 2015

Last Update Submitted That Met QC Criteria

November 6, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC11-080
  • 2011-004582-32 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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