Trial | NCT01898065  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    20
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 Started
Jun 30
2012
Primary Completion
Nov 30
2014
Study Completion
Feb 28
2015
Last Update
Nov 09
2015
Estimate

Drug 18-F-MISO

PET scan with the 18 Fluoro Misonidazole

  • Other names: 18 Fluoro Misonidazole

PET imaging, 18 F-miso Experimental

Single Arm study

Criteria 

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
No Results Posted