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

NCT05815316 | Withdrawn Phase 2 DMC

• 1 other identifier: RF-2021-12372278
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (1)

18F-PSMA-1007

EXPERIMENTAL

All patients undergo the same experimental procedure

Drug: 18F-PSMA-1007

Interventions

18F-PSMA-1007 DRUG

(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

18F-PSMA-1007

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior diagnosis of prostate cancer
• Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated GFR lower or equal to 50mls/min)
• Contraindication to prostate biopsy

Sponsors & Collaborators

• IRCCS San Raffaele: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 18, 2023
• Study Start: April 30, 2023
• Primary Completion: July 31, 2025
• Study Completion: April 29, 2026
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share