文章：

PROSTest：一种新型液体活检分子检测方法，可准确指导前列腺特异性抗原升高男性进行前列腺癌活检决策，无论直肠指检结果如何

PROSTest, a Novel Liquid Biopsy Molecular Assay, Accurately Guides Prostate Cancer Biopsy Decision-Making in Men with Elevated PSA Irrespective of DRE Findings

原文发布日期：6 December 2025

DOI: 10.3390/cancers17243908

类型: Article

开放获取: 是

英文摘要：

Background/Objectives: Elevated PSAs combined with an abnormal digital rectal examination (DRE) are strong indicators of the possibility of a prostate cancer (PCa) and are used to guide biopsy decisions. We evaluated whether PROSTest, a novel, clinically validated, blood-based multigene mRNA test could aid in biopsy decision-making irrespective of DRE results in subjects ≥45 years with PSA ≥ 3 ng/mL.Methods: A retrospective cohort analysis was performed with a prespecified statistical analysis plan to test the null hypothesis that an abnormal DRE does not materially affect the sensitivity, specificity, or overall stratification performance of PROSTest. The pool included 327 subjects aged ≥45 years with abnormal PSA (≥3 ng/mL) who had undergone DRE and prostate biopsy. Diagnostic performance of PROSTest (measured pre-biopsy) was evaluated within two PSA strata (3–10 ng/mL and >10 ng/mL) and compared to DRE in the same strata. Metrics including sensitivity, specificity, positive and negative predictive values, and accuracy were calculated.Results: Among 327 subjects, 215 had PSA 3–10 ng/mL and 112 had PSA > 10 ng/mL. A total of 131 cancers (40.1%) were diagnosed. PROSTest achieved high sensitivity (93.9–96.6%), specificity (82.4–92.7%), and overall accuracy (up to 94.1%) across all DRE/PSA combinations. The DRE+/PROSTest+ group demonstrated similarly high sensitivity (96.6%) and specificity (92.7%), comparable to the DRE−/PROSTest+ group. Multivariate analysis confirmed PROSTest as an independent predictor of PCa (OR: 154,p< 0.0001), outperforming DRE.Conclusions: PROSTest provides highly accurate risk stratification in men with elevated PSA, independent of DRE findings and may be used with PSA to much more effectively guide biopsy decisions.

摘要翻译： 

背景/目的：前列腺特异性抗原（PSA）升高联合直肠指检（DRE）异常是前列腺癌（PCa）可能性的重要指标，常用于指导活检决策。本研究评估了PROSTest（一种经临床验证的新型血液多基因mRNA检测）在PSA≥3 ng/mL且年龄≥45岁的受试者中，能否独立于DRE结果辅助活检决策。方法：采用预先设定的统计分析方案进行回顾性队列分析，检验"DRE异常不会实质性影响PROSTest的敏感性、特异性或整体分层性能"的零假设。研究队列包括327名年龄≥45岁、PSA异常（≥3 ng/mL）并接受过DRE和前列腺活检的受试者。在两个PSA分层（3-10 ng/mL和>10 ng/mL）中评估PROSTest（活检前检测）的诊断性能，并与同层级的DRE进行比较。计算了敏感性、特异性、阳性/阴性预测值和准确度等指标。结果：327名受试者中，215人PSA为3-10 ng/mL，112人PSA>10 ng/mL。共诊断出131例癌症（40.1%）。在所有DRE/PSA组合中，PROSTest均表现出高敏感性（93.9-96.6%）、高特异性（82.4-92.7%）和整体准确度（最高达94.1%）。DRE阳性/PROSTest阳性组显示出与DRE阴性/PROSTest阳性组相当的高敏感性（96.6%）和特异性（92.7%）。多变量分析证实PROSTest是PCa的独立预测因子（OR:154，p<0.0001），其性能优于DRE。结论：PROSTest能为PSA升高男性提供高度准确的风险分层，该结果独立于DRE发现，可与PSA联合使用以更有效地指导活检决策。

原文链接：

PROSTest, a Novel Liquid Biopsy Molecular Assay, Accurately Guides Prostate Cancer Biopsy Decision-Making in Men with Elevated PSA Irrespective of DRE Findings