血和尿液生物标记算法与系统活检用于老年男性前列腺癌检测:随机试验,因徒劳而提前终止
Torben Brøchner Pedersen1, Charlotte Aaberg Poulsen2, Martin Lund3
1Department of Urology, Odense University Hospital, Odense, Denmark. torben.b.pedersen@rsyd.dk.
Scandinavian journal of urology
|March 4, 2026
概括
老年男性前列腺癌的算法选测试减少了活检,但错过了显著的癌症. 在算法选和标准活检方法之间,生活质量仍然可比.
科学领域:
- 泌尿器科 泌尿器科 泌尿器科 泌尿器科
- 在瘤学瘤学.
- 生物标志物研究 生物标志物研究
背景情况:
- 老年男性的前列腺癌诊断往往涉及到平衡攻击性疾病的检测,避免不必要的活检.
- 标准系统活检是目前的诊断标准,但它可能导致过度诊断和过度治疗.
- 正在开发新型诊断工具,如算法选测试,以提高诊断准确性和患者的治疗结果.
研究的目的:
- 为了比较算法选测试的灵敏度和特异性与标准系统活检,以检测老年男性的侵袭性前列腺癌 (国际泌尿病学学会等级组≥2) 的敏感性和特异性.
- 评估算法选对进行的前列腺活检数量的影响.
- 评估患者报告的结果,包括生活质量,在两个研究手臂.
主要方法:
- 一项随机对照试验招募了70岁或以上怀疑患有前列腺癌的男性.
- 参与者被随机分配1:1到算法选手臂或标准系统活检手臂.
- 算法分离臂使用了来自尿液和血的10基因mRNA面板,与临床数据和PSA水平相结合,以预测临床显著的前列腺癌. 用癌症治疗-前列腺 (FACT-P) 功能的评估得分来衡量患者报告的结果.
主要成果:
- 这项研究包括202名男性,由于算法的性能不佳,该研究被提前终止.
- 与标准系统活检相比,算法选手臂检测到较少的惰性癌症 (7.9%vs. 19%) 和较少的临床显著癌症 (26%vs. 40%).
- 在24个月的时间里,两组之间没有观察到患者报告的生活质量 (FACT-P得分) 的显著差异.
结论:
- 基于生物标志物的算法选方法减少了前列腺活检的数量,但也减少了临床上显著的前列腺癌的检测.
- 虽然减少了活检,但该算法的性能不足于最佳,导致错过了诊断.
- 这两种诊断策略都导致了怀疑患有前列腺癌的老年男性的生活质量相似.
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