Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Prostate | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- 164 new diagnoses, 108 BCR, and 171 follow-up
- description
- 1\. 164 new diagnoses. 2.108 BCR. 3. 171 follow-up
Primary outcomes (1)
- measure
- Diagnostic Accuracy of PSMA-RADS v1.0 and v2.0
- timeFrame
- One year
- description
- 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
Secondary outcomes (1)
- measure
- Inter-rater Agreement of PSMA-RADS v1.0 and v2.0
- timeFrame
- One year
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDAlmalki YE, Basha MAA, Ali SA, Donkol RH, Hamed MAG, Metwally MI, Hassan RMA, Frere RAF, Abdul Rahman AAE, Libda YI, Mahmoud NEM, Radwan MHSS, Eladl IM, Elsheikh AM, Zaitoun MMA, Mohamed Mohamed AS, AbdelHamid GA, Tantawy HF, Badr SE, Mosallam W, Al-Shatouri M, S Abo Shanab W, Dawoud TM, Khater HM, Abouelkheir RT, Abdelhamed H, Obaya AA, Elshafaay BS, Basha AMA, Mohammad RMA, Ebaid NY. Comparison of Prostate-specific Membrane Antigen Reporting and Data System Version 1.0 versus 2.0 for Prostate Cancer Assessment. Radiol Imaging Cancer. 2025 May;7(3):e240390. doi: 10.1148/rycan.240390. PMID 40377421