男性重复活检时的 MyProstateScore：一种简单检测方法的验证。
MyProstateScore in men considering repeat biopsy: validation of a simple testing approach.
机构信息
Department of Urology, Vanderbilt University Medical Center, Nashville, TN, USA.
Vanderbilt-Ingram Cancer Center, Nashville, TN, USA.
出版信息
Prostate Cancer Prostatic Dis. 2023 Sep;26(3):563-567. doi: 10.1038/s41391-022-00633-3. Epub 2022 Dec 30.
BACKGROUND
Men with persistent risk of Grade Group (GG) ≥ 2 cancer after a negative biopsy present a unique clinical challenge. The validated MyProstateScore test is clinically-available for pre-biopsy risk stratification. In biopsy-naïve patients, we recently validated a straightforward testing approach to rule-out GG ≥ 2 cancer with 98% negative predictive value (NPV) and 97% sensitivity. In the current study, we established a practical MPS-based testing approach in men with a previous negative biopsy being considered for repeat biopsy.
METHODS
Patients provided post-digital rectal examination urine prior to repeat biopsy. MyProstateScore was calculated using the validated, locked model including urinary PCA3 and TMPRSS2:ERG scores with serum PSA. In a clinically-appropriate primary (i.e., training) cohort, we identified a lower (rule-out) threshold approximating 90% sensitivity and an upper (rule-in) threshold approximating 80% specificity for GG ≥ 2 cancer. These thresholds were applied to an external validation cohort, and performance measures and clinical outcomes associated with their use were calculated.
RESULTS
MyProstateScore thresholds of 15 and 40 met pre-defined performance criteria in the primary cohort (422 patients; median PSA 6.4, IQR 4.3-9.1). In the 268-patient validation cohort, 25 men (9.3%) had GG ≥ 2 cancer on repeat biopsy. The rule-out threshold of 15 provided 100% NPV and sensitivity for GG ≥ 2 cancer and would have prevented 23% of unnecessary biopsies. Use of MyProstateScore >40 to rule-in biopsy would have prevented 67% of biopsies while maintaining 95% NPV. In the validation cohort, the prevalence of GG ≥ 2 cancer was 0% for MyProstateScore 0-15, 6.5% for MyProstateScore 15-40, and 19% for MyProstateScore >40.
CONCLUSIONS
In patients who previously underwent a negative prostate biopsy, the MyProstateScore values of 15 and 40 yielded clinically-actionable rule-in and rule-out risk groups. Using this straightforward testing approach, MyProstateScore can meaningfully inform patients and physicians weighing the need for repeat biopsy.
背景
对于经过阴性活检后仍持续存在 GG≥2 级癌症风险的男性，这是一个独特的临床挑战。经过验证的 MyProstateScore 检测可用于活检前的风险分层。在初次活检的患者中，我们最近采用了一种直接的检测方法，可以以 98%的阴性预测值（NPV）和 97%的敏感性排除 GG≥2 级癌症。在本研究中，我们在考虑重复活检的既往阴性活检患者中建立了一种实用的基于 MPS 的检测方法。
方法
患者在重复活检前提供直肠指检后的尿液。使用经过验证的锁定模型，包括尿液 PCA3 和 TMPRSS2:ERG 评分以及血清 PSA 计算 MyProstateScore。在一个合适的临床原发性（即训练）队列中，我们确定了一个较低（排除）阈值，其敏感性接近 90%，一个较高（纳入）阈值，其特异性接近 80%，用于 GG≥2 级癌症。将这些阈值应用于外部验证队列，并计算了与使用这些阈值相关的性能指标和临床结果。
结果
MyProstateScore 的阈值为 15 和 40，满足原发性队列（422 例患者；中位 PSA 6.4，四分位距 4.3-9.1）的预定义性能标准。在 268 例验证队列中，25 例（9.3%）男性在重复活检中存在 GG≥2 级癌症。排除阈值 15 对 GG≥2 级癌症的 NPV 和敏感性为 100%，可避免 23%的不必要活检。将 MyProstateScore＞40 用于活检纳入，可避免 67%的活检，同时保持 95%的 NPV。在验证队列中，MyProstateScore 为 0-15 的患者 GG≥2 级癌症的患病率为 0%，MyProstateScore 为 15-40 的患者为 6.5%，MyProstateScore＞40 的患者为 19%。
结论
在先前进行过阴性前列腺活检的患者中，MyProstateScore 的值为 15 和 40 产生了可操作的纳入和排除风险组。使用这种简单的检测方法，MyProstateScore 可以为权衡重复活检必要性的患者和医生提供有意义的信息。
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