18F-PSMA PET/MRI for the Diagnosis of Clinically Significant Prostate Cancer

• Status: Not yet recruiting
• Trial end date: 2026-04-29
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS San Raffaele

Criteria

Inclusion Criteria:

1. Men at least 18 years of age referred with clinical suspicion of prostate cancer candidate for prostate biopsy

2. Feasibility to undergo all procedures listed in protocol

3. Ability to provide written informed consent

Exclusion Criteria:

1. Prior diagnosis of prostate cancer

2. Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated GFR lower or equal to 50mls/min)

3. Contraindication to prostate biopsy