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Prospective Validation of PSMA-RADS

NCT06359717 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 477

Last updated 2025-08-14

No results posted yet for this study

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.

Conditions

  • Cancer Prostate

Sponsors & Collaborators

  • Zagazig University

    lead OTHER_GOV

Principal Investigators

  • Mohammad A. Basha, MD · Zagazig University

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2025-08-10
Completion
2025-08-20

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06359717 on ClinicalTrials.gov