This mini review summarizes the currently available clinical biofluid assays for PCa. The second most prevalent cancer worldwide is PCa. PCa is a heterogeneous disease, with a large percentage of prostate tumors being indolent, and with a relatively slow metastatic potential. However, due to the high case numbers, the absolute number of PCa-related deaths is still high. In fact, it causes the second highest number of cancer deaths in American men. As a first step for the diagnosis of PCa, the PSA test has been widely used. However, it has low specificity, which results in a high number of false positives leading to overdiagnosis and overtreatment. Newer derivatives of the original PSA test, including the Food and Drug Administration (FDA)-approved 4K (four kallikreins) and the PHI (Prostate Health Index) blood tests, have higher specificities. Tissue-based PCa tests are problematic as biopsies are invasive and have limited accuracy due to prostate tumor heterogeneity. Liquid biopsies offer a minimally or non-invasive choice for the patients, while providing a more representative reflection of the spatial heterogeneity in the prostate. In addition to the abovementioned blood-based tests, urine is a promising source of PCa biomarkers, offering a supplementary avenue for early detection and improved tumor classification. Four urine-based PCa tests are either FDA- or CLIA-approved: PCA3 (PROGENSA), ExoDX Prostate Intelliscore, MiPS, and SelectMDx. We will discuss these urine-based, as well as the blood-based, clinical PCa tests in more detail. We also briefly discuss a few promising biofluid marker candidates (DNA methylation, micro-RNAs) which are not in clinical application. As no single assay is perfect, we envision that a combination of biomarkers, together with imaging, will become the preferred practice.
本微型综述总结了当前可用于前列腺癌（PCa）的临床生物流体检测方法。前列腺癌是全球第二大常见癌症，作为一种异质性疾病，大部分前列腺肿瘤呈惰性生长，转移潜能相对较低。然而，由于病例基数庞大，前列腺癌相关死亡绝对数量仍然居高不下，事实上它已成为美国男性癌症死亡的第二大原因。 前列腺特异性抗原（PSA）检测作为前列腺癌诊断的初步筛查手段已被广泛应用，但其特异性较低，导致大量假阳性结果，进而引发过度诊断和治疗。基于PSA改良的新一代检测方法——包括美国食品药品监督管理局（FDA）批准的4K（四种激肽释放酶）检测和前列腺健康指数（PHI）血液检测——具有更高的特异性。组织活检虽能提供病理信息，但因具有侵入性且受肿瘤异质性影响准确性有限，而液体活检技术为患者提供了微创或无创的选择，并能更全面地反映前列腺的空间异质性。 除上述血液检测外，尿液作为前列腺癌生物标志物的重要来源，为早期检测和肿瘤分级提供了补充途径。目前已有四种尿液检测方法获得FDA或临床实验室改进修正案（CLIA）认证：PCA3（PROGENSA检测）、ExoDX前列腺智能评分、MiPS检测以及SelectMDx检测。本文将对这些尿液检测及血液检测方法进行详细探讨，同时简要介绍尚未进入临床应用但具有潜力的生物标志物（如DNA甲基化、微小RNA等）。鉴于单一检测方法均存在局限性，我们预见未来通过多生物标志物联合检测并结合影像学技术，将成为临床实践的首选方案。
肿瘤(癌症)患者之家