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NCT Number: NCT01898065

Evaluation of Hypoxia by PET With F-Miso in 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.

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Key information

Conditions

Prostate Adenocarcinoma Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

CHU Poitiers, Poitiers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

18-F-MISO

Drug

PET scan with the 18 Fluoro Misonidazole

Other names: 18 Fluoro Misonidazole

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Collaborators

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

Registry information

Official study title

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

Acronym: HYPOXProstat

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jul 12, 2013
Registry last updated
Nov 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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