Plas Stefan, Melchior Felix, Aigner Gerhard P, Frantzi Maria, Pencik Jan, Kafka Mona, Heidegger Isabel
Medical University of Innsbruck, Department of Urology, Innsbruck, Austria.
Department of Biomarker Research, Mosaiques diagnostics GmbH, Hannover, Germany.
Crit Rev Oncol Hematol. 2025 Jun;210:104699. doi: 10.1016/j.critrevonc.2025.104699. Epub 2025 Mar 17.
Prostate cancer (PCa) screening primarily relies on Prostate-Specific Antigen (PSA), which has low specificity and therefore leads to unnecessary biopsies. Consequently, there is a growing need for, ideally, non-invasive biomarkers. Liquid biopsy, a diagnostic approach analyzing circulating tumor components in body fluids, has emerged as a promising diagnostic tool for various cancers, including PCa.
To evaluate recent evidence on urine-based biomarkers for the detection of PCa, we conducted a systematic review in accordance with the PRISMA guidelines. Our literature search identified a total of 286 studies, of which 66 met our inclusion criteria (men suspected of PCa with no prior history of PCa). After assessing the risk of bias using the QUADAS-2 tool, studies on five distinct urinary biomarker tests were included for further analysis.
Tests that do not rely on digital rectal examination (non-DRE), such as Exosome Dx Prostate IntelliScore (EPI) and Protexam Prostate Status Management (PSM)/Prostate Check-Up (PSU), demonstrated strong performance in detecting PCa, particularly clinically significant PCa. Meanwhile, the MyProstateScore test (MPS) showed the highest efficacy among tests utilizing urine samples collected post-DRE. Unfortunately, the performance of the biomarker test with the most available studies, PCA3 ProGensa® Score, was underwhelming with only moderate sensitivity and specificity.
Despite promising results from various urine-based biomarker tests, we are currently unable to recommend one specific test for implementation into clinical practice. The broad heterogeneity of the studies conducted hindered the ability to perform a meta-analysis, and prospective randomized trials providing clinical evidence are still lacking.
前列腺癌（PCa）筛查主要依赖前列腺特异性抗原（PSA），其特异性较低，因此会导致不必要的活检。因此，对理想的非侵入性生物标志物的需求日益增长。液体活检是一种分析体液中循环肿瘤成分的诊断方法，已成为包括PCa在内的各种癌症的一种有前景的诊断工具。
为了评估基于尿液的生物标志物检测PCa的最新证据，我们按照PRISMA指南进行了系统综述。我们的文献检索共识别出286项研究，其中66项符合我们的纳入标准（怀疑患有PCa且无PCa既往史的男性）。使用QUADAS-2工具评估偏倚风险后，纳入了五项不同尿液生物标志物检测的研究进行进一步分析。
不依赖直肠指检（非DRE）的检测，如外泌体Dx前列腺智能评分（EPI）和Protexam前列腺状态管理（PSM）/前列腺检查（PSU），在检测PCa，尤其是临床显著性PCa方面表现出强大性能。同时，MyProstateScore检测（MPS）在利用DRE后采集的尿液样本的检测中显示出最高疗效。遗憾的是，研究最多的生物标志物检测——PCA3 ProGensa®评分，其性能并不理想，敏感性和特异性仅为中等。
尽管各种基于尿液的生物标志物检测取得了有前景的结果，但我们目前无法推荐一种特定检测用于临床实践。所开展研究的广泛异质性阻碍了进行荟萃分析的能力，且仍缺乏提供临床证据的前瞻性随机试验。
