Chang Edward K, Gadzinski Adam J, Nyame Yaw A
Department of Urology, University of Washington Medical Center, Seattle, WA, USA.
Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Asian J Urol. 2021 Oct;8(4):343-353. doi: 10.1016/j.ajur.2021.06.003. Epub 2021 Jun 23.
There is no consensus on the role of biomarkers in determining the utility of prostate biopsy in men with elevated prostate-specific antigen (PSA). There are numerous biomarkers such as prostate health index, 4Kscore, prostate cancer antigen 3, ExoDX, SelectMDx, and Mi-Prostate Score that may be useful in this decision-making process. However, it is unclear whether any of these tests are accurate and cost-effective enough to warrant being a widespread reflex test following an elevated PSA. Our goal was to report on the clinical utility of these blood and urine biomarkers in prostate cancer screening.
We performed a systematic review of studies published between January 2000 and October 2020 to report the available parameters and cost-effectiveness of the aforementioned diagnostic tests. We focus on the negative predictive value, the area under the curve, and the decision curve analysis in comparing reflexive tests due to their relevance in evaluating diagnostic screening tests.
Overall, the biomarkers are roughly equivalent in predictive accuracy. Each test has additional clinical utility to the current diagnostic standard of care, but the added benefit is not substantial to justify using the test reflexively after an elevated PSA.
Our findings suggest these biomarkers should not be used in binary fashion and should be understood in the context of pre-existing risk predictors, patient's ethnicity, cost of the test, patient life-expectancy, and patient goals. There are more recent diagnostic tools such as multi-parametric magnetic resonance imaging, polygenic single-nucleotide panels, IsoPSA, and miR Sentinel tests that are promising in the realm of prostate cancer screening and need to be investigated further to be considered a consensus reflexive test in the setting of prostate cancer screening.
对于生物标志物在确定前列腺特异性抗原（PSA）升高男性的前列腺活检效用方面的作用，目前尚无共识。有多种生物标志物，如前列腺健康指数、4K评分、前列腺癌抗原3、ExoDX、SelectMDx和Mi-前列腺评分，可能在这一决策过程中有用。然而，尚不清楚这些检测中是否有任何一种足够准确且具有成本效益，足以成为PSA升高后的广泛应用的反射性检测。我们的目标是报告这些血液和尿液生物标志物在前列腺癌筛查中的临床效用。
我们对2000年1月至2020年10月期间发表的研究进行了系统综述，以报告上述诊断检测的可用参数和成本效益。由于其在评估诊断性筛查检测中的相关性，我们在比较反射性检测时重点关注阴性预测值、曲线下面积和决策曲线分析。
总体而言，这些生物标志物在预测准确性方面大致相当。每种检测对当前的诊断标准治疗均具有额外的临床效用，但这种额外益处并不足以证明在PSA升高后反射性地使用该检测是合理的。
我们的研究结果表明，这些生物标志物不应以二元方式使用，而应结合现有的风险预测指标、患者种族、检测成本、患者预期寿命和患者目标来理解。有一些更新的诊断工具，如多参数磁共振成像、多基因单核苷酸检测板、IsoPSA和miR Sentinel检测，在前列腺癌筛查领域很有前景，需要进一步研究，以便在前列腺癌筛查中被视为一种共识性的反射性检测。
