Evaluation of Hypoxia by PET With F-Miso in Radiation Therapy of Prostate Cancer
NCT ID: NCT01898065
Last Updated: 2015-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2012-06-30
2015-02-28
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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PET imaging, 18 F-miso
Single Arm study
18-F-MISO
PET scan with the 18 Fluoro Misonidazole
Interventions
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18-F-MISO
PET scan with the 18 Fluoro Misonidazole
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Patient protected by law
18 Years
MALE
No
Sponsors
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Poitiers University Hospital
OTHER
IASON Gmbh, Feldkirchner strasse 4, 8054 Graz-Seiesberg AUSTRIA
UNKNOWN
Cyclopharma
INDUSTRY
Institut Cancerologie de l'Ouest
OTHER
Responsible Party
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Principal Investigators
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SUPIOT Stéphane, MD
Role: PRINCIPAL_INVESTIGATOR
ICO René Gauducheau
Locations
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CHU Poitiers
Poitiers, , France
ICO Rene Gauducheau
Saint-Herblain, , France
Countries
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References
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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.
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.
Related Links
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Sponsor web site
Other Identifiers
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2011-004582-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RC11-080
Identifier Type: -
Identifier Source: org_study_id
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