Prospective Validation of PSMA-RADS — PSMA-RADS  

Cancer Prostate Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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:

• 186 patients with newly diagnosed or recurrent 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.

Clinical Trial Description

Study Design and Patient Population:

• This was a prospective, multicenter study conducted across three institutions from January 2023 to March 2024.

• 208 consecutive patients were initially recruited, with 186 patients included in the final cohort after exclusions (52 newly diagnosed, 134 with biochemical recurrence).

• Key exclusion criteria were inability to undergo PET/CT, allergy to contrast, hepatic/renal impairment, and loss to follow-up.

Imaging Protocol:

• All patients underwent 68Ga-PSMA-11 PET/CT imaging on integrated PET/CT scanners.

• Detailed acquisition protocol is provided, including patient preparation, radiotracer dosing, low-dose CT, PET acquisition, and diagnostic contrast-enhanced CT.

Image Analysis:

• Three experienced nuclear medicine radiologists independently evaluated the anonymized PET/CT images in random order, blinded to clinical data.

• They underwent standardized training on PSMA-RADS criteria before the study.

• For each patient, the scan was divided into 4 regions: prostate/bed, lymph nodes, bones, soft tissues.

• Each region was assessed for uptake intensity, sites relevant for metastases, and CT lesion definition.

• Radiologists assigned PSMA-RADS categories (1-5) to each region and an overall patient score using v1.0 criteria.

• Retrospectively, they re-assigned scores using the updated PSMA-RADS v2.0 criteria after its publication in July 2023.

Reference Standard:

• For newly diagnosed patients, the reference was histopathology from biopsies within 2 weeks before imaging.

• For biochemical recurrence, the reference was histopathology from biopsies (n=151) or 1-year clinical/imaging follow-up (n=37).

Statistical Analysis:

• Diagnostic accuracy was evaluated using a 4-fold table against the reference standard.

• ROC analysis was performed to determine optimal cut-offs and AUCs.

• Inter-rater agreement was assessed using Fleiss' kappa statistic.

• Performance of PSMA-RADS v1.0 and v2.0 were compared.

In summary, this prospective study rigorously evaluated the diagnostic performance and reliability of PSMA-RADS v1.0 on a multi-center cohort using 68Ga-PSMA-11 PET/CT, and compared it head-to-head with the updated version 2.0, with thorough statistical analyses planned. ;

Related Conditions & MeSH terms

• Cancer Prostate

• NCT number: NCT06359717
• Study type: Observational [Patient Registry]
• Source: Zagazig University
• Status: Active, not recruiting
• Start date: January 1, 2023
• Completion date: April 20, 2024