This project aims to evaluate the role of fully hybrid PET/MRI with 18F-PSMA and multiparametric MR imaging (mpMRI) as one-stop approach for the diagnosis of clinically significant prostate cancer (csPCa). This prospective PET/MRI clinical evaluation will ideally 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. The demonstration that, compared to mpMRI alone, the use of PET/MRI with 18F-PSMA has a superior diagnostic accuracy in detecting men with csPCa will strongly support the inclusion of 18F-PSMA as pre-biopsy triage test, in addition to mpMRI in daily clinical practice.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
(3S, 10S, 14S)-1-\[4-\[\[(2S)-4-carboxy-3-\[(2S)-4-carboxy-2-(6-\[18F\]fluoropyridin-3- amido)butanamido\]butanamido\]methyl\]phenyl\]-3- \[(naphtalen-2-yl)methyl\]-1,4,12-trioxo-2,5,11,13-tetraazahexadecane- 10,14,16-tricarboxilyc acid
To assess the accuracy and the predictive value of fully hybrid 18F-PSMA PET/MRI for the diagnosis of csPCa
Diagnostic accuracy measured with sensitivity, specificity, positive and negative predicted value
Time frame: Biopsy at day 90 (+/-90)
To compare the proportion of csPCa missed by 18F-PSMA PET scan or mpMRI alone
The number of csPCa missed by PET and MR imaging when read independently
Time frame: Biopsy at day 90 (+/-90)
To report the change in the detection of clinically insignificant PCa when combining mpMRI and 18F-PSMA PET, and consequently the proportion of unnecessary biopsies potentially spared.
Only in patients with positive mpMRI and negative 18F-PSMA PET: The proportion of clinically insignificant PCa
Time frame: Biopsy at day 90 (+/-90)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.