Clinical Research Directory
Browse clinical research sites, groups, and studies.
Prospective Validation of PSMA-RADS
Sponsor: Zagazig University
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