Clincosm LogoSign in Get a demo

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

Sponsor
IRCCS San Raffaele (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05815316
Collaborator
(none)
167
Enrollment
1
Arm
36
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
167 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Fully Hybrid 18F-PSMA PET/MRI as One-stop Approach for the Diagnosis of Clinically Significant Prostate Cancer
Anticipated Study Start Date :
Apr 30, 2023
Anticipated Primary Completion Date :
Jul 31, 2025
Anticipated Study Completion Date :
Apr 29, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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)]

    Diagnostic accuracy measured with sensitivity, specificity, positive and negative predicted value

  2. To compare the proportion of csPCa missed by 18F-PSMA PET scan or mpMRI alone [Biopsy at day 90 (+/-90)]

    The number of csPCa missed by PET and MR imaging when read independently

  3. 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)]

    Only in patients with positive mpMRI and negative 18F-PSMA PET: The proportion of clinically insignificant PCa

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • IRCCS San Raffaele

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Maria Picchio, Associate Professor, IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT05815316
Other Study ID Numbers:
  • RF-2021-12372278
First Posted:
Apr 18, 2023
Last Update Posted:
Apr 18, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Apr 18, 2023