Prospective Validation of PSMA-RADS

NCT06359717 | Active Not Recruiting DMC

• 1 other identifier: ZU-10490
• Study Type: observational
• Target: 477
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

gallium 68 PSMA-11; Prostatic Neoplasms; Positron Emission Tomography; Computed Tomography; Prospective Studies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Inter-rater Agreement of PSMA-RADS v1.0 and v2.0

  One year

Study Arms (1)

164 new diagnoses, 108 BCR, and 171 follow-up

1\. 164 new diagnoses. 2.108 BCR. 3. 171 follow-up

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* A total of 477 consecutive patients were initially recruited from three institutions between January 2023 and August 2024. * After applying the exclusion criteria, the final study cohort comprised 443 patients. * The cohort included three groups of patients: 164 new diagnoses, 108 BCR, and 171 follow-up

You may qualify if:

• Patients with newly diagnosed prostate cancer
• Patients with biochemical recurrence of prostate cancer
• Ability to undergo 68Ga-PSMA-11 PET/CT imaging (e.g., no contraindications such as weight limitations, claustrophobia, inability to lie still)
• No allergy to contrast media used for the diagnostic CT component
• Adequate hepatic and renal function to receive the radiotracer
• Willingness to provide informed consent for participation in the study

You may not qualify if:

• Inability to undergo PET/CT scan due to weight (e.g., \>180 kg) (n=5)
• Claustrophobia or inability to lie still throughout the scanning duration (n=3)
• Allergy to contrast media (n=2)
• Hepatic impairment (n=5)
• Renal failure (n=2)
• Patients lost during follow-up (n=7)

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Mohammad Abd Alkhalik Basha

Zagazig, Select, 44631, Egypt

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Mohammad A. Basha, MD

  Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 11, 2024
• Study Start: January 1, 2023
• Primary Completion: August 10, 2025
• Study Completion: August 20, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)