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Clinical trial

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

ID
Name
RF-2021-12372278
Description
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.
Trial arms
Trial start
2023-04-30
Estimated PCD
2025-07-31
Trial end
2026-04-29
Status
Not yet recruiting
Phase
Early phase I
Treatment
18F-PSMA-1007
(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
Arms:
18F-PSMA-1007
Size
167
Primary endpoint
To assess the accuracy and the predictive value of fully hybrid 18F-PSMA PET/MRI for the diagnosis of csPCa
Biopsy at day 90 (+/-90)
To compare the proportion of csPCa missed by 18F-PSMA PET scan or mpMRI alone
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.
Biopsy at day 90 (+/-90)
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 167, 'type': 'ESTIMATED'}}
Updated at
2023-04-18

1 organization

1 product

1 indication

Organization
IRCCS San Raffaele
Product
18F-PSMA-1007
Indication
Prostate Cancer