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

Fully hybrid 18F-PSMA PET/MRI as one-stop approach for the diagnosis of clinically significant prostate cancer - PET/MRI with 18F-PSMA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-003905-31-IT

Enrollment

167

Registered

2023-02-08

Start date

2023-07-14

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with clinical suspicion of clinically relevant prostate cancer MedDRA version: 21.1 Level: LLT Classification code 10026389 Term: Malignant neoplasm of prostate System Organ Class: 100000004864

Interventions

Trade Name: Radelumin Product Name: [18F]PSMA-1007 Product Code: [18FPSMA-1007] Pharmaceutical Form: Solution for injection INN or Proposed INN: [18F]PSMA-1007 CAS Number: 2043321-19-6 Current Sponsor

Eligibility

Sex/Gender

Male

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 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.	—

Measure

Time frame

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 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.

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: At the end of enrollment, approximately 30 months.	—

Countries

Italy

Contacts

Public ContactClinical Trial Center

Ospedale San Raffaele

ctc.trialstartup@hsr.it0226436102

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026