斯德哥尔摩3多种族前列腺癌检测队列(SEPTA):一项前瞻性多中心试验。

IF 42.1 1区 医学 Q1 ONCOLOGY Journal of Clinical Oncology Pub Date : 2024-11-10 Epub Date: 2024-07-22 DOI:10.1200/JCO.24.00152
Hari T Vigneswaran, Martin Eklund, Andrea Discacciati, Tobias Nordström, Rebecca A Hubbard, Nathan Perlis, Michael R Abern, Daniel M Moreira, Scott Eggener, Paul Yonover, Alexander K Chow, Kara Watts, Michael A Liss, Gregory R Thoreson, Andre L Abreu, Geoffrey A Sonn, Thorgerdur Palsdottir, Anna Plym, Fredrik Wiklund, Henrik Grönberg, Adam B Murphy
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引用次数: 0

摘要

目的:亚裔、黑人和西班牙裔男性在前列腺癌(PCa)临床试验中的代表性不足。很少有新型前列腺癌生物标志物在不同人群中得到验证。我们旨在确定斯德哥尔摩 3 是否能提高不同人群的前列腺癌检测率:一项观察性前瞻性多中心(17 个地点)临床试验(2019-2023 年),辅以在泌尿科诊所环境中前瞻性招募的参与者(2008-2020 年),纳入了怀疑患有 PCa 并接受前列腺活检的男性。活组织检查前,收集样本以测量斯德哥尔摩3风险评分。参数包括前列腺特异性抗原(PSA)、游离 PSA、KLK2、GDF15、PSP94、种系风险(单核苷酸多态性)、年龄、家族史和既往阴性活检。主要终点是检测出国际泌尿病理学会(ISUP)≥2级癌症(有临床意义的PCa,csPC)。两个主要目的是:(1) 证明使用斯德哥尔摩3检测csPC的灵敏度(0.8下限95% CI非劣效边距)不优于PSA(相对灵敏度);(2) 通过减少良性结果或低级别癌症的活检,证明其特异性更强(相对特异性):共纳入 2,129 名活检参与者:亚裔(16%,350 人)、黑人或非裔美国人(黑人;24%,505 人)、西班牙裔或拉丁裔和白人(西班牙裔;14%,305 人)以及非西班牙裔或非拉丁裔和白人(白人;46%,969 人)。总体而言,与 PSA ≥4 ng/mL 相比,Stockholm3 的灵敏度并不逊色(相对灵敏度:0.95 [95% CI,0.92 至 0.99]),特异性则高出近三倍(相对特异性:2.91 [95% CI,2.63 至 3.22])。不同种族和民族亚群的结果一致:灵敏度(0.91-0.98)和特异性(2.51-4.70)均不低于前者。与 PSA 相比,Stockholm3 可将良性和 ISUP 1 活检率总体降低 45%,在不同种族和民族亚群中降低 42% 至 52%:结论:在大量不同的人群中,Stockholm3 能显著减少不必要的前列腺活检,同时在检测 csPC 方面保持与 PSA 相似的灵敏度。
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Stockholm3 in a Multiethnic Cohort for Prostate Cancer Detection (SEPTA): A Prospective Multicentered Trial.

Purpose: Asian, Black, and Hispanic men are underrepresented in prostate cancer (PCa) clinical trials. Few novel prostate cancer biomarkers have been validated in diverse cohorts. We aimed to determine if Stockholm3 can improve prostate cancer detection in a diverse cohort.

Methods: An observational prospective multicentered (17 sites) clinical trial (2019-2023), supplemented by prospectively recruited participants (2008-2020) in a urology clinic setting included men with suspicion of PCa and underwent prostate biopsy. Before biopsy, sample was collected for measurement of the Stockholm3 risk score. Parameters include prostate-specific antigen (PSA), free PSA, KLK2, GDF15, PSP94, germline risk (single-nucleotide polymorphisms), age, family history, and previous negative biopsy. The primary endpoint was detection of International Society of Urological Pathology (ISUP) Grade ≥2 cancer (clinically significant PCa, csPC). The two primary aims were to (1) demonstrate noninferior sensitivity (0.8 lower bound 95% CI noninferiority margin) in detecting csPC using Stockholm3 compared with PSA (relative sensitivity) and (2) demonstrate superior specificity by reducing biopsies with benign results or low-grade cancers (relative specificity).

Results: A total of 2,129 biopsied participants were included: Asian (16%, 350), Black or African American (Black; 24%, 505), Hispanic or Latino and White (Hispanic; 14%, 305), and non-Hispanic or non-Latino and White (White; 46%, 969). Overall, Stockholm3 showed noninferior sensitivity compared with PSA ≥4 ng/mL (relative sensitivity: 0.95 [95% CI, 0.92 to 0.99]) and nearly three times higher specificity (relative specificity: 2.91 [95% CI, 2.63 to 3.22]). Results were consistent across racial and ethnic subgroups: noninferior sensitivity (0.91-0.98) and superior specificity (2.51-4.70). Compared with PSA, Stockholm3 could reduce benign and ISUP 1 biopsies by 45% overall and between 42% and 52% across racial and ethnic subgroups.

Conclusion: In a substantially diverse population, Stockholm3 significantly reduces unnecessary prostate biopsies while maintaining a similar sensitivity to PSA in detecting csPC.

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来源期刊
Journal of Clinical Oncology
Journal of Clinical Oncology 医学-肿瘤学
CiteScore
41.20
自引率
2.20%
发文量
8215
审稿时长
2 months
期刊介绍: The Journal of Clinical Oncology serves its readers as the single most credible, authoritative resource for disseminating significant clinical oncology research. In print and in electronic format, JCO strives to publish the highest quality articles dedicated to clinical research. Original Reports remain the focus of JCO, but this scientific communication is enhanced by appropriately selected Editorials, Commentaries, Reviews, and other work that relate to the care of patients with cancer.
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