使用 MyProstateScore 测试排除临床显著癌症：一种简单临床检测方法的验证。
Use of the MyProstateScore Test to Rule Out Clinically Significant Cancer: Validation of a Straightforward Clinical Testing Approach.
机构信息
Department of Urology, University of Michigan, Ann Arbor, Michigan.
Rogel Cancer Center, University of Michigan, Ann Arbor, Michigan.
出版信息
J Urol. 2021 Mar;205(3):732-739. doi: 10.1097/JU.0000000000001430. Epub 2020 Oct 20.
PURPOSE
The MyProstateScore test was validated for improved detection of clinically significant (grade group ≥2) prostate cancer relative to prostate specific antigen based risk calculators. We sought to validate an optimal MyProstateScore threshold for clinical use in ruling out grade group ≥2 cancer in men referred for biopsy.
MATERIALS AND METHODS
Biopsy naïve men provided post-digital rectal examination urine prior to biopsy. MyProstateScore was calculated using the validated, locked multivariable model including only serum prostate specific antigen, urinary prostate cancer antigen 3 and urinary TMPRSS2:ERG. The MyProstateScore threshold approximating 95% sensitivity for grade group ≥2 cancer was identified in a training cohort, and performance was measured in 2 external validation cohorts. We assessed the 1) overall biopsy referral population and 2) population meeting guideline based testing criteria (ie, prostate specific antigen 3-10, or <3 with suspicious digital rectal examination).
RESULTS
Validation cohorts were prospectively enrolled from academic (977 patients, median prostate specific antigen 4.5, IQR 3.1-6.0) and community (548, median prostate specific antigen 4.9, IQR 3.7-6.8) settings. In the overall validation population (1,525 patients), 338 men (22%) had grade group ≥2 cancer on biopsy. The MyProstateScore threshold of 10 provided 97% sensitivity and 98% negative predictive value for grade group ≥2 cancer. MyProstateScore testing would have prevented 387 unnecessary biopsies (33%), while missing only 10 grade group ≥2 cancers (3.0%). In 1,242 patients meeting guideline based criteria, MyProstateScore ≤10 provided 96% sensitivity and 97% negative predictive value, and would have prevented 32% of unnecessary biopsies, missing 3.7% of grade group ≥2 cancers.
CONCLUSIONS
In a large, clinically pertinent biopsy referral population, MyProstateScore ≤10 provided exceptional sensitivity and negative predictive value for ruling out grade group ≥2 cancer. This straightforward secondary testing approach would reduce the use of more costly and invasive procedures after screening with prostate specific antigen.
目的
MyProstateScore 检测在提高基于前列腺特异性抗原（PSA）的风险计算器对临床显著（分级组≥2）前列腺癌的检测能力方面得到了验证。我们旨在验证 MyProstateScore 检测的最佳截断值，以便在对接受活检的男性进行临床应用时排除分级组≥2 的癌症。
材料与方法
在活检前，未经活检的男性提供经直肠指检后的尿液样本。使用经过验证的锁定多变量模型计算 MyProstateScore，该模型仅包括血清 PSA、尿前列腺癌抗原 3 和尿 TMPRSS2:ERG。在训练队列中确定了一个接近 95%分级组≥2 癌症敏感度的 MyProstateScore 截断值，并在两个外部验证队列中进行了检测。我们评估了 1）整个活检转诊人群和 2）符合指南测试标准的人群（即 PSA 3-10ng/ml，或 PSA<3ng/ml 且直肠指检可疑）。
结果
验证队列分别来自学术（977 例患者，中位 PSA 4.5ng/ml，IQR 3.1-6.0）和社区（548 例患者，中位 PSA 4.9ng/ml，IQR 3.7-6.8）环境。在整个验证人群（1525 例患者）中，338 例（22%）患者的活检显示分级组≥2 癌症。MyProstateScore 检测截断值为 10 时，对分级组≥2 癌症的敏感度为 97%，阴性预测值为 98%。MyProstateScore 检测可预防 387 例不必要的活检（33%），同时仅漏诊 10 例分级组≥2 癌症（3.0%）。在符合指南标准的 1242 例患者中，MyProstateScore≤10 时，敏感度为 96%，阴性预测值为 97%，可预防 32%的不必要活检，漏诊 3.7%的分级组≥2 癌症。
结论
在一个大型的、具有临床意义的活检转诊人群中，MyProstateScore≤10 时对排除分级组≥2 癌症具有极好的敏感度和阴性预测值。这种直接的二级检测方法可以减少使用更昂贵和侵入性的检测方法，例如 PSA 筛查。
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