Prostate cancer MedDRA version: 20.0 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: [18F]Fluoromisonidazole-3-fluoro-1-(2'-nitro-1'-imidazolyl)-2-propanol
Product Code: 18F-FMISO
Pharmaceutical Form: Solution for injection
Sponsors
CHU de Bordeaux
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patient above 18 yrs old. • Prostate tumor with histological confirmed diagnosis and highly radiological suspected target on MRI • High risk patient : >T2c grade, Glasgow score > 7 and PSA > 20ng/ml • Surgical treatment chosen during multidisciplinary meeting • ECOG =2 • Patient must have undergone MRI with BOLD sequence less than 6 month prior surgery • Informed signed consent. • Member or beneficiary of a social security system. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: • Patient included in another clinical study • Geographical, social or psychological reasons preventing patient from submitting to the study’s medical monitoring • Patient deprive of liberty, adult subjects to legal protection or unable to give consent • Contraindication to MRI • Contraindication to gadolinium injection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the ability of two imaging modalities (MRI BOLD and PET withFMISO) to demonstrate the hypoxic character of high-risk metastatic prostate tumors by comparing their results after prostatic segmentation with those from histological analysis of surgical specimens. ;Secondary Objective: • Compare the inter-individual variability of hypoxia measurements according to two different modalities, • Provide imaging information for planning volumes in prostate tumor radiotherapy;Primary end point(s): The main endpoint is the hypoxic character of the different prostate segments measured by imaging (MRI BOLD and PET at FMISO) and compare it to the results of the histological analysis of surgical specimens using histologic markers (HIF and CAIX);Timepoint(s) of evaluation of this end point: 2 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Compare the inter-individual variability of the hypoxia measurements according to the different modalities: an inter-individual analysis of the quantitative values will be carried out. • Compare the performance of multiparametric prostatic MRI with the BOLD sequence relative to the histological examination of the surgical specimens: an analysis of MRI performance will be performed by comparing ROC curves;Timepoint(s) of evaluation of this end point: 2 months | — |
Countries
France
Contacts
Public ContactSophie Regueme
CHU de Bordeaux
Outcome results
None listed