This project aims to evaluate the role of fully hybrid PET/MRI with 18FPSMA and multiparametric MR imaging (mpMRI) as one-stop approach for the diagnosis of clinically significant prostate cancer (csPCa). Our main hypothesis is that adding 18F-PSMA PET to mpMRI prior to biopsy, will reduce the number of false negative findings, while at the same time, allowing also to reduce the number of unnecessary prostate biopsies in patients with low-risk, clinically indolent PCa.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
167
18F-PSMA PET/MRI
U.O. of Nuclear Medicine, ,Ospedale San Raffaele
Milan, Milano, Italy
RECRUITINGTo assess the accuracy and the predictive value of fully hybrid 18F-PSMA PET/MRI for the diagnosis of clinically significant prostate cancer (csPCa)
Diagnostic accuracies of 18F-PSMA PET and mpMRI will be calculated by means of sensitivity: true positive/(true positive + false negative) and specificity: true negative/(false positive + true negative) using the prostate biopsy result as reference standard.
Time frame: PET/MRI: day 0 prostate biopsy: day 0-90 days
To compare the proportion of csPCa missed by 18F-PSMA PET scan or mpMRI alone To report the reduction in the detection of clinically insignificant PCa when combining mpMRI and 18F-PSMA PET
The proportion of csPCa (defined by analysis of prostate biopsy cores, ISUP grade equal or higher than 2) missed by PSMA PET scan or mpMRI alone will be calculated.
Time frame: PET/MRI: day 0 prostate biopsy: day 0-90 days
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