National Evidence-based Healthcare Collaborating Agency, Seoul, Korea.
Department of Urology, Yonsei University Wonju College of Medicine, Wonju, Korea.
Investig Clin Urol. 2022 May;63(3):251-261. doi: 10.4111/icu.20210429.
A prostate-specific antigen (PSA) cutoff of 4 ng/mL has been widely used for prostate cancer screening in population-based 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.
We systematically reviewed the literature by searching major databases until March 2020, and a meta-analysis and quality assessment were performed.
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.
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.
在基于人群的前列腺癌筛查中，前列腺特异性抗原（PSA）的截断值为 4ng/ml 已被广泛应用。然而，在医院环境中，PSA 截断值在 4ng/ml 以下诊断前列腺癌的准确性尚不确定。我们系统地回顾了 PSA 截断值在 4ng/ml 以下的医院环境中的准确性。
我们系统地检索了主要数据库的文献，直到 2020 年 3 月，并进行了荟萃分析和质量评估。
在完成筛选过程后，共有 11 项研究纳入。荟萃分析显示，PSA 截断值在 4ng/ml 以下的敏感性为 0.92，特异性为 0.16。分层综合接收者操作特征曲线下的面积为 0.87，阳性似然比为 1.23，阴性似然比为 0.46，诊断比值比为 2.64。根据截断范围，PSA 的敏感性和特异性不同：2 至 2.99ng/ml 时为 0.94 和 0.17，3 至 3.99ng/ml 时为 0.92 和 0.16。在 2 至 2.99ng/ml 和 3 至 3.99ng/ml 范围内，PSA 截断值的敏感性和特异性无显著差异。
尽管 PSA 截断值<3ng/ml 比 PSA≥3ng/ml 更敏感和特异，但在前列腺癌的诊断中，敏感性和特异性无显著差异。因此，临床医生应根据临床情况和患者特征选择合适的 PSA 截断值。
