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

I

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)

20 participants in 1 patient group

PET imaging, 18 F-miso
Experimental group
Description:
Single Arm study
Treatment:
Drug: 18-F-MISO

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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