- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01898065
Evaluation of Hypoxia by PET With F-Miso in Radiation Therapy of Prostate Cancer (HYPOXProstat)
Evaluation of Hypoxia by PET With 18-FluoroMisonidazole During Radiation Therapy of Prostate Cancer
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 Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Poitiers, France, 86000
- CHU Poitiers
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St Herblain, France, 44805
- ICO René Gauducheau
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PET imaging, 18 F-miso
Single Arm study
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PET scan with the 18 Fluoro Misonidazole
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To characterize changes in tumor hypoxia (PET with 18F-MISO) during radiation therapy of prostate cancer.
Time Frame: 3 to 4 weeks after beginning of radiation therapy
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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.
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3 to 4 weeks after beginning of radiation therapy
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To compare hypoxia imaging (PET with 18F-MISO) with anatomical imaging (PET with 18F-choline) to study the feasibility of a tailored treatment.
Time Frame: before and 3 to 4 weeks after the begining of radiation therapy
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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.
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before and 3 to 4 weeks after the begining of radiation therapy
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: SUPIOT Stéphane, MD, ICO René Gauducheau
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC11-080
- 2011-004582-32 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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