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NCT06359717

Prospective Validation of PSMA-RADS

Sponsor: Zagazig University

View on ClinicalTrials.gov

Summary

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.

Official title: Prostatic Specific Membrane Antigen Reporting and Data System (PSMA-RADS) Version 1.0: Prospective Validation and Comparison to Updated Version (v2.0)

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

477

Start Date

2023-01-01

Completion Date

2025-08-20

Last Updated

2025-08-14

Healthy Volunteers

No

Conditions

Locations (1)

Mohammad Abd Alkhalik Basha

Zagazig, Select, Egypt