Comparison of Prostate-specific Membrane Antigen Reporting and Data System Version 1.0 versus 2.0 for Prostate Cancer Assessment

Yassir Edrees Almalki; Mohammad Abd Alkhalik Basha; Susan Adil Ali; Ragab Hani Donkol; Maged Abdel Galil Hamed; Maha Ibrahim Metwally; Rania Mostafa A Hassan; Reem Abdel Fattah Frere; Amro Ahmed Esmat Abdul Rahman; Yasmin Ibrahim Libda; Nader E M Mahmoud; Mohamed Hesham Saleh Saleh Radwan; Ibrahim M Eladl; Amgad M Elsheikh; Mohamed M A Zaitoun; Al-Shaimaa Mohamed Mohamed; Ghada Adel AbdelHamid; Heba Fathy Tantawy; Shimaa Elsayed Badr; Walid Mosallam; Mohammad Al-Shatouri; Waleed S Abo Shanab; Tamer Mahmoud Dawoud; Hamada M Khater; Rasha Taha Abouelkheir; Heba Abdelhamed; Ahmed Ali Obaya; Basant Sh Elshafaay; Ahmed M Abdelkhalik Basha; Reem M Abdelkhalik Mohammad; Noha Yahia Ebaid

doi:10.1148/rycan.240390

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.

Authors

Yassir Edrees Almalki^{1

2}, Mohammad Abd Alkhalik Basha³, Susan Adil Ali⁴, Ragab Hani Donkol⁵, Maged Abdel Galil Hamed³, Maha Ibrahim Metwally³, Rania Mostafa A Hassan³, Reem Abdel Fattah Frere³, Amro Ahmed Esmat Abdul Rahman³, Yasmin Ibrahim Libda³, Nader E M Mahmoud³, Mohamed Hesham Saleh Saleh Radwan³, Ibrahim M Eladl³, Amgad M Elsheikh³, Mohamed M A Zaitoun³, Al-Shaimaa Mohamed Mohamed³, Ghada Adel AbdelHamid³, Heba Fathy Tantawy³, Shimaa Elsayed Badr³, Walid Mosallam⁶, Mohammad Al-Shatouri⁶, Waleed S Abo Shanab⁷, Tamer Mahmoud Dawoud⁸, Hamada M Khater⁹, Rasha Taha Abouelkheir¹⁰, Heba Abdelhamed¹¹, Ahmed Ali Obaya¹¹, Basant Sh Elshafaay¹¹, Ahmed M Abdelkhalik Basha¹², Reem M Abdelkhalik Mohammad¹³, Noha Yahia Ebaid³

Affiliations

¹ Division of Radiology, Department of Medicine, Medical College, Najran University, Najran 66462, Kingdom of Saudi Arabia.
² Medical Imaging Department, McMaster University, Faculty of Health Sciences, Hamilton, Canada.
³ Department of Diagnostic Radiology, Faculty of Human Medicine, Zagazig University, Zagazig, Egypt.
⁴ Department of Diagnostic Radiology, Intervention and Molecular Imaging, Faculty of Human Medicine, Ain Shams University, Cairo, Egypt.
⁵ Department of Diagnostic Radiology, Faculty of Human Medicine, Cairo University, Cairo, Egypt.
⁶ Department of Diagnostic Radiology, Faculty of Human Medicine, Suez Canal University, Esmaelia, Egypt.
⁷ Department of Diagnostic Radiology, Faculty of Human Medicine, Port Said University, Port Said, Egypt.
⁸ Department of Diagnostic Radiology, Faculty of Human Medicine, Tanta University, Tanta, Egypt.
⁹ Department of Diagnostic Radiology, Faculty of Human Medicine, Benha University, Benha, Egypt.
¹⁰ Department of Diagnostic Radiology, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.
¹¹ Department of Clinical Oncology and Nuclear Medicine, Faculty of Human Medicine, Zagazig University, Zagazig, Egypt.
¹² Faculty of General Medicine, St. Petersburg State University, Egypt Branch, Cairo, Egypt.
¹³ College of Medicine, Arab Academy for Science, Technology & Maritime Transport, El Alamein, Egypt.

Abstract

Purpose To assess diagnostic performance and reliability of Prostate-specific Membrane Antigen Reporting and Data System (PSMA-RADS) version 1.0 in evaluating prostate cancer (PCa) and compare it with the updated version (version 2.0). Materials and Methods This prospective, multicenter study was conducted between June 2022 and August 2024. Participants with PCa underwent gallium 68 (⁶⁸Ga) PSMA-11 PET/CT imaging and were divided into three groups: new diagnoses, biochemical recurrence (BCR), and follow-up. Three nuclear medicine radiologists independently interpreted the images using PSMA-RADS version 1.0, followed by a retrospective assessment using PSMA-RADS version 2.0. Diagnostic performance was calculated using linear mixed-model analysis. Histopathology and follow-up data served as reference standards. Interrater agreement was evaluated using the intraclass correlation coefficient (ICC). Results The study included 443 male participants (mean age, 68.6 years ± 8.1 [SD]) divided into new diagnoses (n = 164), BCR (n = 108), and follow-up (n = 171) groups. Compared with PSMA-RADS version 1.0, version 2.0 improved diagnostic accuracy in new diagnoses (95.9% vs 97.4%, P = .02), BCR (92.6% vs 95.7%, P = .004), and follow-up (88.7% vs 94.7%, P < .001). Sensitivity substantially improved in follow-up cases (87.7% vs 95.7%, P < .001). Interrater agreement was comparable between two versions, with lowest reliability in soft tissue evaluation (ICC = 0.36-0.50). Introduction of the PSMA-RADS 5T category to version 2.0 enhanced the characterization of treated metastases, improving correlation with prostate-specific antigen dynamics (r_s = 0.74 vs 0.61, P < .001) and the discrimination of treatment response (88.7% vs 82.3%, P = .02). Conclusion Both PSMA-RADS versions 1.0 and 2.0 were highly accurate and reliable for PCa imaging, with version 2.0 offering significant improvements, particularly in challenging follow-up and BCR cases. Keywords: PET/CT, Urinary, Prostate, Neoplasms-Primary, Oncology, Comparative Studies, Prostate Cancer, PSMA-RADS, Diagnostic Performance, Reliability Clinical trial registration no.: NCT06359717 Supplemental material is available for this article. © RSNA, 2025.

Keywords: Comparative Studies; Diagnostic Performance; Neoplasms-Primary; Oncology; PET/CT; PSMA-RADS; Prostate; Prostate Cancer; Reliability; Urinary.

Publication types

Comparative Study
Multicenter Study

MeSH terms

Aged
Antigens, Surface
Gallium Isotopes
Gallium Radioisotopes
Glutamate Carboxypeptidase II*
Humans
Male
Middle Aged
Positron Emission Tomography Computed Tomography* / methods
Prospective Studies
Prostatic Neoplasms* / diagnostic imaging
Prostatic Neoplasms* / pathology
Reproducibility of Results
Retrospective Studies

Substances

Gallium Radioisotopes
Glutamate Carboxypeptidase II
gallium 68 PSMA-11
FOLH1 protein, human
Gallium Isotopes
Antigens, Surface

Associated data

ClinicalTrials.gov/NCT06359717