Clinical trial NCT01898065: Evaluation of Hypoxia by PET With F-Miso in Radiation Therapy of Prostate Cancer
Official title: Evaluation of Hypoxia by PET With 18-FluoroMisonidazole During Radiation Therapy of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Adenocarcinoma
Keywords: Hypoxia
radiotherapy
PET with 18-F-MISO
MRI
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
Collaborators: name: Poitiers University Hospital
name: IASON Gmbh, Feldkirchner strasse 4, 8054 Graz-Seiesberg AUSTRIA
name: Cyclopharma
First posted: 2013-07-12
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: To characterize changes in tumor hypoxia (PET with 18F-MISO) during radiation therapy of prostate cancer.
timeFrame: 3 to 4 weeks after beginning of radiation therapy
Secondary outcomes:
measure: To compare hypoxia imaging (PET with 18F-MISO) with anatomical imaging (PET with 18F-choline) to study the feasibility of a tailored treatment.
timeFrame: before and 3 to 4 weeks after the begining of radiation therapy
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU Poitiers
city: St Herblain
country: France
facility: ICO Rene Gauducheau
Study officials:
affiliation: ICO René Gauducheau
name: SUPIOT Stéphane, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rasey JS, Koh WJ, Evans ML, Peterson LM, Lewellen TK, Graham MM, Krohn KA. Quantifying regional hypoxia in human tumors with positron emission tomography of [18F]fluoromisonidazole: a pretherapy study of 37 patients. Int J Radiat Oncol Biol Phys. 1996 Sep 1;36(2):417-28. doi: 10.1016/s0360-3016(96)00325-2.
citation: Bentzen SM. Theragnostic imaging for radiation oncology: dose-painting by numbers. Lancet Oncol. 2005 Feb;6(2):112-7. doi: 10.1016/S1470-2045(05)01737-7.