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. 2026 Feb 1;16(2):172.
doi: 10.21037/qims-2025-1928. Epub 2026 Jan 23.

PSMA-RADS 2.0: clinical validation and technical considerations for prostate-specific membrane antigen positron emission tomography/computed tomography image interpretation

Luyi Cheng #  1 , Chaobo Jin #  1 , Huai Zhang #  1 , Zhuxu Sun  1 , Junfu Fan  1 , Tianshuo Yang  1 , Fei Mao  2 , Guangbo Fu  2 , Qiuhu Wang  1 , Xiaobing Niu  2 , Weijing Tao  1
Affiliations

PSMA-RADS 2.0: clinical validation and technical considerations for prostate-specific membrane antigen positron emission tomography/computed tomography image interpretation

Luyi Cheng et al. Quant Imaging Med Surg. .

Abstract

Background: The updated diagnostic framework prostate-specific membrane antigen Reporting and Data System 2.0 (PSMA-RADS 2.0) has been introduced as a standardized scoring system for PSMA positron emission tomography/computed tomography (PET/CT) structured reporting to enhance the accuracy and clinical utility of prostate cancer (PCa) lesion interpretation. This study aims to evaluate the reliability and identify potential limitations of PSMA-RADS 2.0 in clinical applications.

Methods: We conducted a comparative analysis between PSMA-RADS versions 1.0 and 2.0, followed by prospective evaluation of 109 lesions using PSMA-RADS 2.0 criteria. Inter- and intra-reader consistencies were analyzed statistically to evaluate the reliability and practicality of the scoring system. In the context of two independent readings, the inter-reader consistency between experienced readers (ERs) and inexperienced readers (IRs) was evaluated using the intra-class correlation coefficient (ICC).

Results: Compared to version 1.0, PSMA-RADS 2.0 simplified primary PSMA-RADS-1 classification for Category I lesions and introduced PSMA-RADS-5T for post-treatment assessment. Inter-reader correlation coefficients values demonstrated excellent consistency (ERs: 0.964-0.969; IRs: 0.929-0.932). Intra-reader correlation coefficients ranged from 0.920 to 0.985 across all readers. However, challenges persisted in lymph node interpretation (ICC: 0.797-0.823) and post-treatment classification.

Conclusions: PSMA-RADS 2.0 provides a reliable framework for PSMA PET/CT interpretation, even for IRs. Further refinement is needed for post-treatment categorization and lymph node differentiation. The proposed PSMA-RADS-5T sub-classification complete remission/partial remission/stability disease/progression disease (CR/PR/SD/PD) may enhance clinical utility for treatment monitoring.

Keywords: Prostate cancer (PCa); prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT); standardized reporting; treatment response assessment.

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Conflict of interest statement

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://qims.amegroups.com/article/view/10.21037/qims-2025-1928/coif). The authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1
Flowchart of patient screening and selection process. PCa, prostate cancer; PSMA PET/CT, prostate-specific membrane antigen positron emission tomography/computed tomography.
Figure 2
Figure 2
Inter-reader agreement analysis using confusion matrices for PSMA-RADS classification consistency between ERs and IRs. (A) Agreement between ER1 and ER2 in the first reading session (ICC =0.964). (B) Agreement between IR1 and IR2 in the first reading session (ICC =0.929). (C) Agreement between ER1 and ER2 in the second reading session (ICC =0.969). (D) Agreement between IR1 and IR2 in the second reading session (ICC =0.932). ER, experienced reader; ICC, intraclass correlation coefficient; IR, inexperienced reader; PSMA, prostate-specific membrane antigen; RADS, Reporting and Data System; TL, target lesion.
Figure 3
Figure 3
Intra-reader reliability assessment through confusion matrices showing PSMA-RADS scoring consistency across repeated evaluations by ERs and IRs. (A) Intrareader agreement for ER1 (ICC =0.985). (B) Intrareader agreement for ER2 (ICC =0.954). (C) Intrareader agreement for IR1 (ICC =0.920). (D) Intrareader agreement for IR2 (ICC =0.956). ER, experienced reader; ICC, intraclass correlation coefficient; IR, inexperienced reader; PSMA, prostate-specific membrane antigen; RADS, Reporting and Data System.
Figure 4
Figure 4
68Ga-PSMA-11 PET/CT scan in a 69-year-old prostate cancer patient demonstrating physiological uptake in sympathetic ganglia (red arrows) despite stable PSA levels. MIP, maximum intensity projection; PET/CT, positron emission tomography/computed tomography; PSA, prostate-specific antigen; PSMA, prostate-specific membrane antigen.
Figure 5
Figure 5
68Ga-PSMA-11 PET/CT scan of a 53-year-old post-prostatectomy patient with undetectable PSA (<0.006 ng/mL), showing local recurrence (red arrows) with PSMA-negative characteristics. MIP, maximum intensity projection; PET/CT, positron emission tomography/computed tomography; PSA, prostate-specific antigen; PSMA, prostate-specific membrane antigen.
See this image and copyright information in PMC

References

    1. Davis MI, Bennett MJ, Thomas LM, Bjorkman PJ. Crystal structure of prostate-specific membrane antigen, a tumor marker and peptidase. Proc Natl Acad Sci U S A 2005;102:5981-6. 10.1073/pnas.0502101102 - DOI - PMC - PubMed
    1. Wang F, Li Z, Feng X, Yang D, Lin M. Advances in PSMA-targeted therapy for prostate cancer. Prostate Cancer Prostatic Dis 2022;25:11-26. 10.1038/s41391-021-00394-5 - DOI - PubMed
    1. Karimzadeh A, Heck M, Tauber R, Solaris E, Nekolla S, Knorr K, Haller B, D’Alessandria C, Weber WA, Eiber M, Rauscher I. The Impact of PSMA PET-Based Eligibility Criteria Used in the Prospective Phase II TheraP Trial in Metastatic Castration-Resistant Prostate Cancer Patients Undergoing Prostate-Specific Membrane Antigen-Targeted Radioligand Therapy. J Nucl Med 2023;64:1252-8. 10.2967/jnumed.122.265346 - DOI - PubMed
    1. Hartrampf PE, Serfling SE, Michalski K, Buck AK, Werner RA. PSMA PET/CT for Response Assessment of (177)Lu-PSMA Therapy. Semin Nucl Med 2024;54:69-76. 10.1053/j.semnuclmed.2023.06.003 - DOI - PubMed
    1. Esfahani SA, Morris MJ, Sartor O, Frydenberg M, Fanti S, Calais J, Vapiwala N. Standardized template for clinical reporting of PSMA PET/CT scans. Eur J Nucl Med Mol Imaging 2024;52:335-41. 10.1007/s00259-024-06857-w - DOI - PMC - PubMed