Clinical Trial · NCT06359717

Prospective Validation of PSMA-RADS

Overview

This is a prospective, multicenter study aimed at evaluating the diagnostic accuracy and reliability of the Prostate-Specific Membrane Antigen Reporting and Data System (PSMA-RADS) version 1.0 in detecting prostate cancer using 68Ga-PSMA-11 PET/CT imaging. The study also compared the performance of PSMA-RADS v1.0 with the updated version 2.0. Key points: * 477 patients with newly diagnosed, recurrent or follow up prostate cancer underwent 68Ga-PSMA-11 PET/CT imaging. * Three radiologists independently evaluated the scans and assigned PSMA-RADS scores using v1.0, then retrospectively using v2.0. * Diagnostic accuracy was assessed against histopathology and follow-up imaging as reference standards. * Inter-rater agreement was evaluated using Fleiss\' kappa statistic. * The study aimed to validate the diagnostic utility of PSMA-RADS v1.0 and compare it to the updated v2.0.

Sponsor

Sohag University

Contacts

Mohammad A. Basha, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT06359717

Eligibility

Inclusion

Patients with biochemical recurrence of prostate cancer
Adequate hepatic and renal function to receive the radiotracer
Patients with newly diagnosed prostate cancer
Ability to undergo 68Ga-PSMA-11 PET/CT imaging (e.g., no contraindications such as weight limitations, claustrophobia, inability to lie still)
No allergy to contrast media used for the diagnostic CT component

Exclusion

Hepatic impairment (n=5)
Claustrophobia or inability to lie still throughout the scanning duration (n=3)
Inability to undergo PET/CT scan due to weight (e.g., \>180 kg) (n=5)
Allergy to contrast media (n=2)
Renal failure (n=2)
Patients lost during follow-up (n=7)