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

NCT06305390 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2026-04-01

No results posted yet for this 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.

Conditions

  • Clinical Suspicion of Prostate Cancer

Interventions

DIAGNOSTIC_TEST

PET/MRI

18F-PSMA PET/MRI

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • Arturo Chiti, MD · IRCCS Ospedale San Raffaele

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-04
Primary Completion
2026-03-24
Completion
2027-04-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06305390 on ClinicalTrials.gov