NCT06359717Active, not recruiting
Prospective Validation of PSMA-RADS
Prostatic Specific Membrane Antigen Reporting and Data System (PSMA-RADS) Version 1.0: Prospective Validation and Comparison to Updated Version (v2.0)
Source: ClinicalTrials.gov · Last updated 14 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 477 (estimated)
- First submitted
- 29 Mar 2024
- Start date
- 1 Jan 2023
- Primary completion date
- 10 Aug 2025
- Lead sponsor
- Zagazig University
- Diseases
- Prostate cancer
- NCT number
- NCT06359717
What you commit to
- Study type: Observational
- Planned participants: 477
- From 1 Jan 2023 to the primary completion date, 10 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Allergy to contrast media (n=2)
- Hepatic impairment (n=5)
- Renal failure (n=2)
Other
- 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)
- Patients lost during follow-up (n=7)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mohammad Abd Alkhalik Basha Coordinator of this site? Confirm its status | Zagazig | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.