Diagnostic accuracy of prostate-specific antigen and prostate-specific antigen density in patients suspected of having prostate cancer in South Korea - A large, multi-institutional registry

Sep 23, 2026

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Lowering the prostate-specific antigen (PSA) cutoff for biopsy in prostate cancer screening has raised concerns about overdiagnosis and overtreatment. This retrospective cohort study evaluated the diagnostic accuracy of a lower PSA cutoff in Korean men and assessed whether combined criteria could improve clinical utility. Data from 17,539 men undergoing first biopsy for lower urinary tract symptoms across six tertiary hospitals (2011–2019) compared PSA and PSA density (PSAD) thresholds across age groups. Results showed no major impact from lowering PSA alone; combining PSA, PSAD, and age improved screening accuracy while reducing unnecessary biopsies.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages11

Reading Time28 min

AccessFree to download

Introduction

Materials and Methods

Results

Conclusions

Keywords

Original Article-Urological Oncology Investig Clin Urol 2026;67:32-42. [https://doi.org/10.4111/icu.20250299](https://doi.org/10.4111/icu.20250299)[ ](https://doi.org/10.4111/icu.20250299)[pISSN 2466-0493](pISSN 2466-0493) • eISSN 2466-054X Diagnostic accuracy of prostate-specific antigen and prostate-specific antigen density in patients suspected of having prostate cancer in South Korea: A large, multi-institutional registry Ji Eun Yun1,*, Kwang Suk Lee2,*, Hakmin Lee3, Sang Hyub Lee4, Jae Hung Jung5, Eu Chang Hwang6, Na Rae Lee1, Woong Kyu Han7, Su-Yeon Yu8 1Division of Healthcare Research, National Evidence-based Healthcare Collaborating Agency, Seoul, 2Department of Urology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, 3Department of Urology, Seoul National University Bundang Hospital, Seongnam, 4Department of Urology, Kyung Hee University Medical Center, Seoul, 5Department of Urology, Yonsei University Wonju College of Medicine, Wonju, 6Department of Urology, Chonnam National University Medical School, Gwangju, 7Department of Urology, Yonsei University College of Medicine, Seoul, 8Department of Pharmacy, College of Pharmacy, Kangwon National University, Seoul, Korea Purpose: Owing to concerns about overdiagnosis and overtreatment associated with prostate-specific antigen (PSA) screening for early prostate cancer detection, recent guidelines have lowered the PSA cutoff value for recommending biopsy. This study aimed to evaluate the diagnostic accuracy of a lower PSA cutoff value in Korean men and to explore whether additional clinically useful criteria can be proposed. Materials and Methods: A retrospective cohort study of 17,539 Korean men who underwent their first prostate biopsy due to lower urinary tract symptoms was conducted at six tertiary hospitals between 2011 and 2019. The diagnostic performance of various PSA and PSA density (PSAD) cutoff values across age groups was evaluated by analyzing the data on demographics, PSA levels, PSAD, and biopsy results. Results: Among the participants, 44.1% were diagnosed with prostate cancer, of whom 73.7% had clinically significant cancer (Gleason score ≥7) . No significant differences in cancer detection rates were found between PSA levels of 3–4 ng/mL and 4–5 ng/ mL across age groups. PSAD further increased the area under the receiver operating characteristic curve by 5.5%–11.4% . Conclusions: These findings suggest that diagnostic yield may not be impacted by merely lowering the PSA cutoff. Rather, combining PSA, PSAD, and patient age enhances screening accuracy while minimizing unnecessary biopsies and overdiagnosis. Our results highlight the need for more data to refine national screening guidelines and promote a more tailored approach to prostate cancer screening in Korea. Keywords: Diagnostic test; Prostate cancer; Prostate-specific antigen; Retrospective studies This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ([http://creativecommons.org/licenses/by-nc/4.0](http://creativecommons.org/licenses/by-nc/4.0)) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. Received: June 28, 2025 • Revised: September 11, 2025 • Accepted: October 16, 2025 • Published online: December 17, 2025 Corresponding Author: Su-Yeon Yu [https://orcid.org/0000-0001-5488-5068](https://orcid.org/0000-0001-5488-5068) Department of Pharmacy, College of Pharmacy, Kangwon National University, 1 Gangwondaehak-gil, Chuncheon 24341, Korea TEL: +82-33-250-6905, E-mail: [suyeon.yu@kangwon.ac.kr](suyeon.yu@kangwon.ac.kr) *These authors contributed equally to this study and should be considered co-first authors. ⓒThe Korean Urological Association [www.icurology.org](www.icurology.org) PSA and PSAD accuracy in Korean men INTRODUCTION The global incidence and mortality of prostate cancer approxima

FAQs

What was the purpose of this study?

To evaluate whether a lower PSA cutoff improves diagnostic accuracy in Korean men and to explore additional clinically useful criteria.

How was the study conducted?

A retrospective cohort of 17,539 Korean men who underwent their first prostate biopsy due to lower urinary tract symptoms was analyzed across six tertiary hospitals from 2011 to 2019.

What were the main findings regarding PSA cutoff lowering?

Lowering the PSA cutoff did not significantly change diagnostic yield; combining PSA, PSAD, and patient age improved screening accuracy while minimizing unnecessary biopsies and overdiagnosis.

Sep 23, 2026

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