Role of the PET/resonance imaging method (which allows the acquisition of a PET and an MRI exam simultaneously) using the 18F-PSMA radiotracer (which binds to tumor cell proteins allowing their visualization) in the diagnosis of prostate cancer clinically significant

Phase 1

• Conditions: Patients with clinical suspicion of clinically relevant prostate cancer; MedDRA version: 21.1Level: LLTClassification code 10026389Term: Malignant neoplasm of prostateSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2022-003905-31-IT
• Lead Sponsor: OSPEDALE SAN RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-08
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 167

Inclusion Criteria

1) Patients 18 years of age or older, identified as suspects for clinically significant prostate cancer
2) Ability to undergo all protocol scrutiny
3) Ability to provide informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 83
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 84

Exclusion Criteria

1) Previous diagnosis of prostate cancer
2) Contraindications to perform the MRI examination (e.g. claustrophobia, pacemaker, estimated GFR less than or equal to 50mls/min)
3) Contraindications to perform the prostate biopsy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the diagnostic accuracy of 18F-PSMA PET/MRI for the diagnosis of clinically relevant prostate cancer;Secondary Objective: 1) Compare the proportion of patients with clinically relevant prostate cancer not identified by PET and MRI when examined separately<br>2) To report the reduction of clinically irrelevant tumors by combining MRI and PET imaging and therefore the number of biopsies that could have been avoided.;Primary end point(s): Diagnostic accuracy measured by sensitivity, specificity, and positive and negative predictive values;Timepoint(s) of evaluation of this end point: At the end of enrollment, approximately 30 months.

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: At the end of enrollment, approximately 30 months.