An interventional study of F-MISO PET imaging in Prostate Cancer, sponsored by University Hospital, Bordeaux. Withdrawn at 1 site in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-27.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Diagnostic
This feasibility exploratory study objective is to assess the ability of combined MRI BOLD and 18F-MISO PET imaging to visualize tumor hypoxia compare to histological results obtained after radical prostatectomy in order to, in time, be able to identify patient with bad prognostic and to offer them the best therapeutic strategy.
Prostate cancer is the fisrt one in male with 80.000 new cases each year in France. Forty thousand curative treatments are performed each year, but 25 to 30% of these patients will present a cancer reccurence after radical surgery or conformationnal radiotherapy, Tissu hypoxia seems to be mainly responsible of the local reccurence and conduct to molecular damages that creates carcinogenesis and tumor agressitivity. This hypoxia inhibits the DNA healing and the apoptosis but increases the angiogenesis, that leads to treatment resistance. L. Marignol \&al clearly showed that hypoxia may have a main role in hormonal resistance. Furthermore, M. Milosevic \& al showed that hypoxia is an independent factor of local reccurence after radiotherapy. Nowadays, new technics of IMRT in radiotherapy planning could be able to target an hypoxic prostate region to prevent reccurence. Patients who are eligible to radical prostatectomy will benefit of a prostate MRI with BOLD sequences and a 18F-misonidazole PET before surgery. The results of these two technics will be compared to the histological results using CAIX and HIF immunohistochemistery markers
Exclusion Criteria:
F-MISO PET imaging will be added to the preoperative staging explorations of a patient with high risk prostate cancer candidate to radical prostatectomy. Patient will be selected during multidisciplinary meeting and urology consultation of Bordeaux and Toulouse university hospitals. Functional MRI imaging should be available before surgery. If patient consent to participate in the study, F-MISO PET imaging will be planed before prostatectomy. Results of this exam will not be considered for patient therapeutic management.
Device: F-MISO PET imaging
F-MISO PET imaging will be added to the preoperative staging explorations of a patient with high risk prostate cancer candidate to radical prostatectomy. Patient will be selected during multidisciplinary meeting and urology consultation of Bordeaux and Toulouse university hospitals. Functional MRI imaging should be available before surgery. If patient consent to participate in the study, F-MISO PET imaging will be planed before prostatectomy. Results of this exam will not be considered for patient therapeutic management.
comparison between histological results and oxygenation quantitative values from MRI and PET exams
Correlation study between anatomopatology data, product by prostatectomy anatomic piece, using HIF1-CAIX histological markers and: * on one hand PET FMISO uptake * on the other hand, MRI BOLD signal
Time frame: Inclusion, 1 month
quantitative analysis
a quantitative analysis of inter-individual variability will be done in order o compare inter-individual variability of hypoxia measures between the two imaging modalities
Time frame: Inclusion, 1 month
Plan to share: No
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University Hospital, Bordeaux