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

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

Recruiting
18 years and older
Male
Phase N/A

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Overview

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

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

Study details
    Clinical Suspicion of Prostate Cancer

NCT06305390

IRCCS San Raffaele

21 March 2024

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