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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 November 2015 |
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Main ID: |
NCT01898065 |
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Date of registration:
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03/07/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of Hypoxia by PET With F-Miso in Radiation Therapy of Prostate Cancer
HYPOXProstat |
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Scientific title:
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Evaluation of Hypoxia by PET With 18-FluoroMisonidazole During Radiation Therapy of Prostate Cancer |
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Date of first enrolment:
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June 2012 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01898065 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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SUPIOT Stéphane, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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ICO René Gauducheau |
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Key inclusion & exclusion criteria
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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 or Gleason 6 and PSA 10-20 ng / ml, T
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostate Adenocarcinoma
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Intervention(s)
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Drug: 18-F-MISO
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Primary Outcome(s)
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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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Secondary Outcome(s)
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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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Secondary ID(s)
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RC11-080
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2011-004582-32
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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