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

Phase 2

Withdrawn

• Conditions: Prostate Cancer
• Interventions: Drug: 18F-PSMA-1007

• Registration Number: NCT05815316
• Lead Sponsor: IRCCS San Raffaele

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-21
• Study First Submitted QC: 2023-04-03
• Study First Posted: 2023-04-18
• Study Start: 2023-04-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-13
• Primary Completion: 2025-07-31
• Study Completion: 2026-04-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: 167

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-PSMA-1007	18F-PSMA-1007	All patients undergo the same experimental procedure

Primary Outcome Measures

Name	Time	Method
To compare the proportion of csPCa missed by 18F-PSMA PET scan or mpMRI alone	Biopsy at day 90 (+/-90)	The number of csPCa missed by PET and MR imaging when read independently
To assess the accuracy and the predictive value of fully hybrid 18F-PSMA PET/MRI for the diagnosis of csPCa	Biopsy at day 90 (+/-90)	Diagnostic accuracy measured with sensitivity, specificity, positive and negative predicted value
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.	Biopsy at day 90 (+/-90)	Only in patients with positive mpMRI and negative 18F-PSMA PET: The proportion of clinically insignificant PCa