Actively Recruiting

Phase 2
Age: 18Years +
MALE
NCT06305390

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

Led by IRCCS San Raffaele · Updated on 2026-04-01

167

Participants Needed

1

Research Sites

173 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Milan, Milano, Italy, 20132

Actively Recruiting

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Research Team

M

Maria Picchio, MD

CONTACT

R

Rachele Di Donato, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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