Clinical Trial

Fully Hybrid 18F-PSMA PET/MRI as One-stop Approach for the Diagnosis of Clinically Significant Prostate Cancer.

Study acronym: RF2021-1237227
Recruiting Phase 2
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Summary
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-03-05; most recent amendment 2026-03-26.
Trial Details
NCT Number NCT06305390
Lead Sponsor IRCCS San Raffaele
Conditions Clinical Suspicion of Prostate Cancer
Enrollment 167 participants
Start Date 2023-12-04
Primary Completion 2026-03-24 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2026-04-01