Investig Clin Urol.  2022 May;63(3):251-261. 10.4111/icu.20210429.

Diagnostic accuracy of prostate-specific antigen below 4 ng/mL as a cutoff for diagnosing prostate cancer in a hospital setting: A systematic review and meta-analysis

Affiliations
  • 1National Evidence-based Healthcare Collaborating Agency, Seoul, Korea
  • 2Department of Urology, Yonsei University Wonju College of Medicine, Wonju, Korea
  • 3Center of Evidence Based Medicine, Institute of Convergence Science, Yonsei University, Seoul, Korea
  • 4Department of Urology, Yonsei University College of Medicine, Seoul, Korea
  • 5Department of Urology, Chonnam National University Medical School, Gwangju, Korea
  • 6Department of Urology, Gangnam Sevrance Hospital, Yonsei University College of Medicine, Seoul, Korea
  • 7Department of Urology, Kyung Hee University Medical Center, Seoul, Korea
  • 8Department of Urology, Seoul National University Bundang Hospital, Seongnam, Korea

Abstract

Purpose
A prostate-specific antigen (PSA) cutoff of 4 ng/mL has been widely used for prostate cancer screening in populationbased settings. However, the accuracy of PSA below 4 ng/mL as a cutoff for diagnosing prostate cancer in a hospital setting is inconclusive. We systematically reviewed the accuracy of PSA below 4 ng/mL cutoff in a hospital setting.
Materials and Methods
We systematically reviewed the literature by searching major databases until March 2020, and a metaanalysis and quality assessment were performed.
Results
A total of 11 studies were included at the completion of the screening process. The meta-analysis showed a sensitivity of 0.92 and a specificity of 0.16 for a PSA cutoff below 4 ng/mL. The area under the hierarchical summary receiver operating characteristic curve was 0.87, the positive likelihood ratio was 1.23, the negative likelihood ratio was 0.46, and the diagnostic odds ratio was 2.64. PSA sensitivities and specificities varied according to the cutoff range: 0.94 and 0.17 for 2 to 2.99 ng/mL, and 0.92 and 0.16 for 3 to 3.99 ng/mL, respectively. No significant differences in the sensitivity and specificity of PSA cutoffs in the range of 2 to 2.99 ng/mL and 3 to 3.99 ng/mL were found.
Conclusions
Although a PSA cutoff <3 ng/mL is relatively more sensitive and specific than PSA ≥3 ng/mL, no significant differences in sensitivity and specificity were found in the diagnosis of prostate cancer. Therefore, clinicians should choose an appropriate PSA cutoff on the basis of clinical circumstances and patients’ characteristics.

Keyword

Diagnosis; Prostate-specific antigen; Prostatic neoplasms
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