在一次阴性活检后，存在持续风险等级（GG）≥2的前列腺癌男性患者，这是一个独特的临床挑战。经验证的MyProstateScore测试可用于前活检风险分层。在从未进行过活检的患者中，我们最近验证了一种简单的测试方法，用于排除GG ≥2级前列腺癌，具有98%的负预测值（NPV）和97%的灵敏度。在本研究中，在考虑重复活检的男性患者中，我们建立了一种基于MPS的实用测试方法。患者在重复活检之前进行数字直肠检查后提供尿液。使用已验证的锁定模型，包括尿液PCA3和TMPRSS2：ERG评分和血清PSA计算MyProstateScore。在一个临床上适当的初级（即培训）队列中，我们确定了一个更低的（排除）阈值，约为90%的灵敏度和一个更高的（确认）阈值，约为80%的特异性，用于GG≥2级前列腺癌。这些阈值应用于外部验证队列，计算了与其使用相关的性能指标和临床结果。MyProstateScore的阈值为15和40在初级队列（422名患者；中位数PSA为6.4，IQR为4.3-9.1）中符合预先定义的性能标准。在268名验证队列的患者中，25名男性（9.3％）在重复活检中患有GG≥2级前列腺癌。排除阈值为15为GG≥2级前列腺癌提供了100%的NPV和灵敏度，并且可以防止23%的不必要活检。使用MyProstateScore> 40的决策点将防止67％的活检，同时保持95％的NPV。在验证队列中，GG≥2级前列腺癌的患病率为MyProstateScore 0-15为0％，MyProstateScore 15-40为6.5％，MyProstateScore> 40为19％。在先前接受过负性前列腺活检的患者中，MyProstateScore值为15和40产生了临床可行的决策点。使用这种简单的测试方法，MyProstateScore可以有意义地告知患者和医师衡量是否需要重复活检。 ©2022.作者。

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.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.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.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.© 2022. The Author(s).