RecruitingPhase 2NCT06305390

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

Sponsor

IRCCS San Raffaele

Enrollment

167 participants

Start Date

Dec 4, 2023

Study Type

INTERVENTIONAL

Conditions

Clinical Suspicion of Prostate Cancer

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a combined PET/MRI scan using a special prostate-targeting tracer (18F-PSMA) can detect clinically significant prostate cancer better or more conveniently than separate imaging tests and biopsies done over multiple visits. **You may be eligible if...** - You are a man aged 18 or older - Your doctor suspects you may have prostate cancer and has recommended a biopsy - You are physically able to undergo all the procedures in the study - You can provide written informed consent **You may NOT be eligible if...** - You have already been diagnosed with prostate cancer - You cannot have an MRI scan (for example due to claustrophobia, a pacemaker, or reduced kidney function) - You have a contraindication to prostate biopsy Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Print for Your Doctor Check Your Eligibility

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTPET/MRI

18F-PSMA PET/MRI

Locations(1)

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

Milan, Milano, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06305390