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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01898065

Acronym

HYPOXProstat

Enrollment

Registered

2013-07-12

Start date

2012-06-30

Completion date

2015-02-28

Last updated

2015-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Adenocarcinoma

Keywords

Hypoxia, radiotherapy, PET with 18-F-MISO, MRI

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.

Interventions

DRUG18-F-MISO

PET scan with the 18 Fluoro Misonidazole

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026