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

April 9, 2025 updated by: Maria Picchio, IRCCS San Raffaele

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 18F-PSMA-1007
All patients undergo the same experimental procedure
Drug: 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

What is the study measuring?

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
Time Frame: Biopsy at day 90 (+/-90)
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
Time Frame: Biopsy at day 90 (+/-90)
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.
Time Frame: Biopsy at day 90 (+/-90)
Only in patients with positive mpMRI and negative 18F-PSMA PET: The proportion of clinically insignificant PCa
Biopsy at day 90 (+/-90)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 30, 2023

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

April 29, 2026

Study Registration Dates

First Submitted

March 21, 2023

First Submitted That Met QC Criteria

April 3, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 13, 2025

Last Update Submitted That Met QC Criteria

April 9, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RF-2021-12372278

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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