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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05815316
• Other study ID #: RF-2021-12372278
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 30, 2023
• Est. completion date: April 29, 2026

Study information

• Verified date: April 2023
• Source: IRCCS San Raffaele
• Contact: Maria Picchio, MD
• Phone: +390226436117
• Email: picchio.maria[@]hsr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 167
• Est. completion date: April 29, 2026
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)