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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05815316
Study type Interventional
Source IRCCS San Raffaele
Contact Maria Picchio, MD
Phone +390226436117
Email picchio.maria@hsr.it
Status Not yet recruiting
Phase Phase 2
Start date April 30, 2023
Completion date April 29, 2026

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