Assani Keavash D, Pierce Janene M, Galloway Lan Anh, Tosoian Jeffrey J
Department of Urology, Vanderbilt University Medical Center.
Vanderbilt-Ingram Cancer Center, Nashville Tennessee, USA.
Curr Opin Urol. 2025 Jun 27. doi: 10.1097/MOU.0000000000001308.
Prostate cancer (PCa) is the most common malignancy in men. While prostate-specific antigen (PSA) screening aids early detection, its low specificity leads to unnecessary biopsies and overdiagnosis of low-grade cancers. Blood- and urine-based biomarkers are proposed by clinical guidelines to better identify patients with elevated PSA that can safely avoid more intensive testing (e.g. imaging, biopsy). The current article aims to provide clinicians and researchers with a contemporary assessment of prostate cancer biomarker tests.
This review focused on prebiopsy blood- and urine-based biomarker tests that are commercially-available and included in clinical guidelines. A systematic search identified 955 studies, of which 14 were published in the past 18 months (July 2023-January 2025) and reported performance metrics for clinically significant PCa (csPCa, defined as grade group ≥2). The literature revealed that blood- [Prostate Health Index (PHI), 4Kscore, and IsoPSA] and urine-based tests [SelectMDx, ExoDx IntelliScore (EPI), and MyProstateScore (MPS, MPS2)] maintained high sensitivity for csPCa while significantly reducing unnecessary biopsies performed relative to PSA-based testing. Furthermore, available data suggest that biomarkers can inform the need for biopsy in patients with equivocal (PI-RADS 3) mpMRI.
Commercially-available, noninvasive biomarker tests consistently outperformed PSA and PSA-based risk calculators for detection of csPCa. Clinical use of these tests appears to substantially reduce the proportion of unnecessary biopsies performed, while maintaining detection of the vast majority of significant cancers.
前列腺癌（PCa）是男性中最常见的恶性肿瘤。虽然前列腺特异性抗原（PSA）筛查有助于早期检测，但其低特异性导致不必要的活检以及低级别癌症的过度诊断。临床指南推荐使用基于血液和尿液的生物标志物，以更好地识别PSA升高且可安全避免更强化检测（如影像学检查、活检）的患者。本文旨在为临床医生和研究人员提供对前列腺癌生物标志物检测的当代评估。
本综述聚焦于活检前基于血液和尿液的可商业化获得且纳入临床指南的生物标志物检测。系统检索确定了955项研究，其中14项在过去18个月（2023年7月至2025年1月）发表，并报告了具有临床意义的前列腺癌（csPCa，定义为分级组≥2）的性能指标。文献表明，基于血液的检测[前列腺健康指数（PHI）、4K评分和IsoPSA]以及基于尿液的检测[SelectMDx、ExoDx IntelliScore（EPI）和MyProstateScore（MPS、MPS2）]对csPCa保持高灵敏度，同时相对于基于PSA的检测显著减少了不必要的活检。此外，现有数据表明生物标志物可为PI-RADS 3类磁共振成像（mpMRI）结果不明确的患者的活检需求提供参考。
可商业化获得的非侵入性生物标志物检测在检测csPCa方面始终优于PSA和基于PSA的风险计算器。这些检测的临床应用似乎大幅降低了不必要活检的比例，同时保持了对绝大多数显著癌症的检测。
