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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06305390

Acronym

RF2021-1237227

Enrollment

167

Registered

2024-03-12

Start date

2023-12-04

Completion date

2027-04-01

Last updated

2026-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical Suspicion of Prostate Cancer

Brief 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.

Interventions

DIAGNOSTIC_TESTPET/MRI

18F-PSMA PET/MRI

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
To assess the accuracy and the predictive value of fully hybrid 18F-PSMA PET/MRI for the diagnosis of clinically significant prostate cancer (csPCa)	PET/MRI: day 0 prostate biopsy: day 0-90 days	Diagnostic accuracies of 18F-PSMA PET and mpMRI will be calculated by means of sensitivity: true positive/(true positive + false negative) and specificity: true negative/(false positive + true negative) using the prostate biopsy result as reference standard.

Secondary

Measure	Time frame	Description
To compare the proportion of csPCa missed by 18F-PSMA PET scan or mpMRI alone To report the reduction in the detection of clinically insignificant PCa when combining mpMRI and 18F-PSMA PET	PET/MRI: day 0 prostate biopsy: day 0-90 days	The proportion of csPCa (defined by analysis of prostate biopsy cores, ISUP grade equal or higher than 2) missed by PSMA PET scan or mpMRI alone will be calculated.

Countries

Italy

Contacts

CONTACTMaria Picchio, MD

Picchio.maria@hsr.it02-26436117

CONTACTRachele Di Donato, PhD

didonato.rachele@hsr.it02-26433639

STUDY_DIRECTORArturo Chiti, MD

IRCCS Ospedale San Raffaele

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026