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Clinical Trials in Italy / NCT06305390
Recruiting Phase 2

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

NCT06305390 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS San Raffaele
Phase
Phase 2
Started
2023-12-04
Last updated
2026-04-01

Condition(s) studied

Clinical Suspicion of Prostate Cancer

Investigational drug(s) / intervention(s)

PET/MRI

PET/MRI: 18F-PSMA PET/MRI

Study 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
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
U.O. of Nuclear Medicine, ,Ospedale San Raffaele Milan Milano Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06305390 on ClinicalTrials.gov ↗ ← All trials in Italy