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

NCT06305390 | Recruiting Phase 2

• 1 other identifier: 2022-003905-31
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

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.

Conditions

Clinical Suspicion of Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• To assess the accuracy and the predictive value of fully hybrid 18F-PSMA PET/MRI for the diagnosis of clinically significant prostate cancer (csPCa)

  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.

  PET/MRI: day 0 prostate biopsy: day 0-90 days

Secondary Outcomes (1)

• 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

Study Arms (1)

single arm

EXPERIMENTAL

Diagnostic Test: PET/MRI

Interventions

PET/MRI DIAGNOSTIC_TEST

18F-PSMA PET/MRI

single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men at least 18 years of age referred with clinical suspicion of prostate cancer candidate for prostate biopsy
• Feasibility to undergo all procedures listed in protocol
• Ability to provide written informed consent

You may not qualify if:

• Prior diagnosis of prostate cancer
• Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated GFR lower or equal to 50mls/min)
• Contraindication to prostate biopsy

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

U.O. of Nuclear Medicine, ,Ospedale San Raffaele

Milan, Milano, 20132, Italy

RECRUITING

Study Officials

• Arturo Chiti, MD

  IRCCS Ospedale San Raffaele

  STUDY DIRECTOR

Central Study Contacts

Maria Picchio, MD

CONTACT

02-26436117; Picchio.maria@hsr.it

Rachele Di Donato, PhD

CONTACT

02-26433639; didonato.rachele@hsr.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: December 4, 2023
• Primary Completion: March 24, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

IT (1)