在通过液体活检寻求有效的肿瘤诊断的过程中，细胞外囊泡（EV）已显示出作为潜在生物标志物来源的前景。这项研究解决了西方和中国人群在预测具有临床意义的前列腺癌 (csPCa) 的生物标志物功效方面的差距。我们开发了一种基于尿细胞外囊泡的前列腺评分 (EPS) 模型，利用 EXODUS 技术从 598 名患者中分离 EV，并纳入 FOXA1、PCA3 和 KLK3 的基因表达。我们的研究结果表明，在 234 名患者的训练队列中，EPS 模型的诊断准确性超过了前列腺特异性抗原 (PSA) 测试，曲线下面积 (AUC) 为 0.730，而 PSA 为 0.659 (p = 0.018)。同样，在 101 名男性的验证队列中，EPS 模型的 AUC 为 0.749，明显优于 PSA 的 0.577（p < 0.001）。我们的模型已证明，不必要的前列腺活检可减少 26%，csPCa 病例的漏检率仅为 3%，这表明其在中国人群中的有效性。© 2024 作者。 《Journal of Extracellular Vesicles》由 Wiley periodicals LLC 代表国际细胞外囊泡学会出版。

In the quest for efficient tumor diagnosis via liquid biopsy, extracellular vesicles (EVs) have shown promise as a source of potential biomarkers. This study addresses the gap in biomarker efficacy for predicting clinically significant prostate cancer (csPCa) between the Western and Chinese populations. We developed a urinary extracellular vesicles-based prostate score (EPS) model, utilizing the EXODUS technique for EV isolation from 598 patients and incorporating gene expressions of FOXA1, PCA3, and KLK3. Our findings reveal that the EPS model surpasses prostate-specific antigen (PSA) testing in diagnostic accuracy within a training cohort of 234 patients, achieving an area under the curve (AUC) of 0.730 compared to 0.659 for PSA (p = 0.018). Similarly, in a validation cohort of 101 men, the EPS model achieved an AUC of 0.749, which was significantly better than PSA's 0.577 (p < 0.001). Our model has demonstrated a potential reduction in unnecessary prostate biopsies by 26%, with only a 3% miss rate for csPCa cases, indicating its effectiveness in the Chinese population.© 2024 The Author(s). Journal of Extracellular Vesicles published by Wiley Periodicals LLC on behalf of International Society for Extracellular Vesicles.