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

Recruiting

• Conditions: Clinical Suspicion of Prostate Cancer
• Interventions: Diagnostic Test: PET/MRI

• Registration Number: NCT06305390
• Lead Sponsor: IRCCS San Raffaele

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-04
• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-03-05
• Study First Posted: 2024-03-12
• Status Verified: 2024-09
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-16
• Primary Completion: 2025-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• 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: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
single arm	PET/MRI	-

Primary Outcome Measures

Name	Time	Method
To assess the accuracy and the predictive value of fully hybrid 18F-PSMA PET/MRI for the diagnosis of clinically significant prostate cancer (csPCa)	PET/MRI: day 0 prostate biopsy: day 0-90 days	Diagnostic accuracies of 18F-PSMA PET and mpMRI will be calculated by means of sensitivity: true positive/(true positive + false negative) and specificity: true negative/(false positive + true negative) using the prostate biopsy result as reference standard.

Secondary Outcome Measures

Name	Time	Method
To compare the proportion of csPCa missed by 18F-PSMA PET scan or mpMRI alone To report the reduction in the detection of clinically insignificant PCa when combining mpMRI and 18F-PSMA PET	PET/MRI: day 0 prostate biopsy: day 0-90 days	The proportion of csPCa (defined by analysis of prostate biopsy cores, ISUP grade equal or higher than 2) missed by PSMA PET scan or mpMRI alone will be calculated.

Trial Locations

Locations (1)

U.O. of Nuclear Medicine, ,Ospedale San Raffaele; 🇮🇹 Milano, Italy