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

RecruitingPhase 2Ages 18 Years - anyMaleIRCCS San Raffaele
NCT06305390 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • PET/MRI
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Where

1 site
U.O. of Nuclear Medicine, ,Ospedale San Raffaele
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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