Prospective Validation of PSMA-RADS

Cancer Prostate Clinical Trial

— PSMA-RADS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06359717
• Other study ID #: ZU-10490
• Status: Active, not recruiting
• Start date: January 1, 2023
• Est. completion date: April 20, 2024

Study information

• Verified date: April 2024
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 208
• Est. completion date: April 20, 2024
• Est. primary completion date: April 10, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with newly diagnosed prostate cancer

2. Patients with biochemical recurrence of prostate cancer

3. Ability to undergo 68Ga-PSMA-11 PET/CT imaging (e.g., no contraindications such as weight limitations, claustrophobia, inability to lie still)

4. No allergy to contrast media used for the diagnostic CT component

5. Adequate hepatic and renal function to receive the radiotracer

6. Willingness to provide informed consent for participation in the study

Exclusion Criteria:

1. Inability to undergo PET/CT scan due to weight (e.g., >180 kg) (n=5)

2. Claustrophobia or inability to lie still throughout the scanning duration (n=3)

3. Allergy to contrast media (n=2)

4. Hepatic impairment (n=5)

5. Renal failure (n=2)

6. Patients lost during follow-up (n=7)

Related Conditions & MeSH terms

• Cancer Prostate

Locations

Country	Name	City	State
Egypt	Mohammad Abd Alkhalik Basha	Zagazig	Select

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Accuracy of PSMA-RADS v1.0 and v2.0	The diagnostic accuracy of PSMA-RADS version 1.0 and version 2.0 for detecting prostate cancer lesions using 68Ga-PSMA-11 PET/CT. Diagnostic accuracy will be evaluated using sensitivity, specificity, positive predictive value, and negative predictive value, calculated on a per-patient basis. Histopathological results from biopsy and/or clinical/imaging follow-up will serve as the reference standard	One year
Secondary	Inter-rater Agreement of PSMA-RADS v1.0 and v2.0	The degree of agreement among the three nuclear medicine radiologists in assigning PSMA-RADS categories using version 1.0 and version 2.0 criteria. Inter-rater agreement will be evaluated using Fleiss' kappa statistics	One year