Stockholm3 是一种综合血液检测，融合了蛋白质生物标志物、遗传指标和临床数据，可预测临床上显着的前列腺癌风险（活检后国际泌尿病理学会等级≥2）。我们的研究旨在对 Stockholm3 进行外部验证，并将其性能与使用前列腺特异性抗原 (PSA) 和鹿特丹前列腺癌风险计算器 (RPCRC) 进行临床显着性前列腺癌检测进行比较。我们收集了来自接受前列腺活检的男性的数据。德国 Martini-Klinik，2014 年至 2017 年间。根据升高的 PSA 水平或可疑的直肠指检来选择参与者，所有参与者均接受 10-12 核系统活检，但未进行磁共振成像靶向活检。我们评估了 Stockholm3 和 RPCRC 在临床上有意义的前列腺癌检测方面的性能。此外，我们还比较了建议进行活检的男性比例以及使用 Stockholm3 和 RPCCRC 与 PSA ≥3 ng/ml 进行活检的男性比例。我们的研究涵盖了 405 名接受活检的男性，中位年龄为 66 岁（四分位距 [IQR]：60-72） ），PSA 水平为 7 ng/ml（IQR：5.2-10.8），Stockholm3 得分为 18（IQR：10-34）。其中，128 名男性 (31%) 被诊断出具有临床意义的前列腺癌。与使用 PSA ≥3 ng/ml 作为活检标准相比，采用推荐的 Stockholm3 阈值 (≥15) 可以将不必要的活检减少 52%，同时检测出 92% 的临床显着病例。 Stockholm3 和 RPCCRC 均表现出很强的辨别力，曲线下面积值分别为 0.80（95% 置信区间 [CI]：0.76-0.85）和 0.75（95% CI：0.70-0.80）。 Stockholm3 表现出良好的校准，而 RPCRC 与观察到的结果相比低估了风险。此外，Stockholm3 产生了正的临床净效益，而 RPCCRC 在临床相关阈值方面产生了负的净效益。与 PSA ≥3 ng/ml 相比，Stockholm3 的利用可以检测出 92% 的有临床意义的前列腺癌病例，同时减少 52% 不必要的活检标准，基于我们对接受系统活检的男性队列的分析。在一个由 405 名男性组成的德国临床队列中，Stockholm3（一种用于早期前列腺癌检测的血液测试）表现出良好的临床效益。它发现了大量具有临床意义的病例，同时将未患前列腺癌和临床上不显着前列腺癌的男性中不必要的活检减少了一半以上。版权所有 © 2024。由 Elsevier B.V. 出版。

Stockholm3 is a comprehensive blood test amalgamating protein biomarkers, genetic indicators, and clinical data to predict clinically significant prostate cancer risk (International Society of Urological Pathology grade ≥2 upon biopsy). Our study aims to externally validate Stockholm3 and compare its performance with the use of prostate-specific antigen (PSA) and the Rotterdam Prostate Cancer Risk Calculator (RPCRC) for clinically significant prostate cancer detection.We gathered data from men subjected to prostate biopsies at the Martini-Klinik, Germany, between 2014 and 2017. Participants were selected based on elevated PSA levels or suspicious digital rectal examinations, all undergoing a 10-12-core systematic biopsy without a magnetic resonance imaging-targeted biopsy. We assessed Stockholm3 and RPCRC performance for clinically significant prostate cancer detection. Furthermore, we compared the proportion of men recommended for biopsy and biopsy outcomes with Stockholm3 and RPCRC against PSA ≥3 ng/ml.Our study encompassed 405 biopsied men, with a median age of 66 yr (interquartile range [IQR]: 60-72), PSA levels at 7 ng/ml (IQR: 5.2-10.8), and Stockholm3 scores at 18 (IQR: 10-34). Among them, 128 men (31%) received clinically significant prostate cancer diagnoses. Employing the recommended Stockholm3 threshold (≥15) could have reduced unnecessary biopsies by 52%, while detecting 92% of clinically significant cases compared with using PSA ≥3 ng/ml as a biopsy criterion. Both Stockholm3 and RPCRC exhibited strong discrimination, with area under the curve values of 0.80 (95% confidence interval [CI]: 0.76-0.85) and 0.75 (95% CI: 0.70-0.80), respectively. Stockholm3 demonstrated good calibration, while RPCRC underestimated the risk compared with observed outcomes. Moreover, Stockholm3 yielded positive clinical net benefits, whereas RPCRC yielded negative net benefits for clinically relevant thresholds.Stockholm3 utilization could detect 92% of clinically significant prostate cancer cases while simultaneously reducing unnecessary biopsies by 52%, compared with the PSA ≥3 ng/ml criterion, based on our analysis within a cohort of men who underwent systematic biopsies.In a German clinical cohort of 405 men, Stockholm3, a blood test for early prostate cancer detection, exhibited favorable clinical benefits. It identified a substantial number of clinically significant cases while reducing unnecessary biopsies by over half in men without the disease and those with clinically nonsignificant prostate cancer.Copyright © 2024. Published by Elsevier B.V.