18F-PSMA PET/MRI for the Diagnosis of Clinically Significant Prostate Cancer

Study Overview
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Brief Summary
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This project aims to evaluate the role of fully hybrid PET/MRI with 18F-PSMA and multiparametric MR imaging (mpMRI) as one-stop approach for the diagnosis of clinically significant prostate cancer (csPCa). This prospective PET/MRI clinical evaluation will ideally 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. The demonstration that, compared to mpMRI alone, the use of PET/MRI with 18F-PSMA has a superior diagnostic accuracy in detecting men with csPCa will strongly support the inclusion of 18F-PSMA as pre-biopsy triage test, in addition to mpMRI in daily clinical practice.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: 18F-PSMA-1007


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Prior diagnosis of prostate cancer Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated GFR lower or equal to 50mls/min) Contraindication to prostate biopsy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-PSMA-1007<br>All patients undergo the same experimental procedure | Drug: 18F-PSMA-1007<br>* (3S, 10S, 14S)-1-[4-[[(2S)-4-carboxy-3-[(2S)-4-carboxy-2-(6-[18F]fluoropyridin-3- amido)butanamido]butanamido]methyl]phenyl]-3- [(naphtalen-2-yl)methyl]-1,4,12-trioxo-2,5,11,13-tetraazahexadecane- 10,14,16-tricarboxilyc acid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the accuracy and the predictive value of fully hybrid 18F-PSMA PET/MRI for the diagnosis of csPCa | Diagnostic accuracy measured with sensitivity, specificity, positive and negative predicted value | Biopsy at day 90 (+/-90) | 
| To compare the proportion of csPCa missed by 18F-PSMA PET scan or mpMRI alone | The number of csPCa missed by PET and MR imaging when read independently | Biopsy at day 90 (+/-90) | 
| To report the change in the detection of clinically insignificant PCa when combining mpMRI and 18F-PSMA PET, and consequently the proportion of unnecessary biopsies potentially spared. | Only in patients with positive mpMRI and negative 18F-PSMA PET: The proportion of clinically insignificant PCa | Biopsy at day 90 (+/-90) |