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Abstract：
OBJECTIVE: To assess the clinical performance of ProsTAV®, a blood-based test based on telomere associate variables (TAV) measurement, to support biopsy decision-making when diagnosing suspicious prostate cancer (PCa).
METHODS: Preliminary data of a prospective observational pragmatic study of patients with prostate-specific antigen (PSA) levels 3-10 ng/ml and suspicious PCa. Results were combined with other clinical data, and all patients underwent prostate biopsies according to each center\'s routine clinical practice, while magnetic resonance imaging (MRI) before the prostate biopsy was optional. Sensitivity, specificity, positive and negative predicted values, and subjects where biopsies could have been avoided using ProsTAV were determined.
RESULTS: The mean age of the participants (n = 251) was 67.4 years, with a mean PSA of 5.90 ng/ml, a mean free PSA of 18.9%, and a PSA density of 0.14 ng/ml. Digital rectal examination was abnormal in 21.1% of the subjects, and according to biopsy, the prevalence of significant PCa was 47.8%. The area under the ROC curve of ProsTAV was 0.7, with a sensitivity of 0.90 (95% CI, 0.85-0.95) and specificity of 0.27 (95% CI, 0.19-0.34). The positive and negative predictive values were 0.53 (95% CI, 0.46-0.60) and 0.74 (95% CI, 0.62-0.87), respectively. ProsTAV could have reduced the biopsies performed by 27% and showed some initial evidence of a putative benefit in the diagnosis pathway combined with MRI.
CONCLUSIONS: ProsTAV increases the prediction capacity of significant PCa in patients with PSA between 3 and 10 ng/ml and could be considered a complementary tool to improve the patient diagnosis pathway.
METHODS: Preliminary data of a prospective observational pragmatic study of patients with prostate-specific antigen (PSA) levels 3-10 ng/ml and suspicious PCa. Results were combined with other clinical data, and all patients underwent prostate biopsies according to each center\'s routine clinical practice, while magnetic resonance imaging (MRI) before the prostate biopsy was optional. Sensitivity, specificity, positive and negative predicted values, and subjects where biopsies could have been avoided using ProsTAV were determined.
RESULTS: The mean age of the participants (n = 251) was 67.4 years, with a mean PSA of 5.90 ng/ml, a mean free PSA of 18.9%, and a PSA density of 0.14 ng/ml. Digital rectal examination was abnormal in 21.1% of the subjects, and according to biopsy, the prevalence of significant PCa was 47.8%. The area under the ROC curve of ProsTAV was 0.7, with a sensitivity of 0.90 (95% CI, 0.85-0.95) and specificity of 0.27 (95% CI, 0.19-0.34). The positive and negative predictive values were 0.53 (95% CI, 0.46-0.60) and 0.74 (95% CI, 0.62-0.87), respectively. ProsTAV could have reduced the biopsies performed by 27% and showed some initial evidence of a putative benefit in the diagnosis pathway combined with MRI.
CONCLUSIONS: ProsTAV increases the prediction capacity of significant PCa in patients with PSA between 3 and 10 ng/ml and could be considered a complementary tool to improve the patient diagnosis pathway.
摘要：
目的：评估ProsTAV®的临床性能，基于端粒关联变量(TAV)测量的基于血液的测试，在诊断可疑前列腺癌（PCa）时支持活检决策。
方法：一项针对前列腺特异性抗原（PSA）水平为3-10ng/ml且可疑PCa的患者的前瞻性观察性实用研究的初步数据。结果结合其他临床资料,所有患者均根据各中心的常规临床实践进行前列腺活检,而前列腺活检前的磁共振成像（MRI）是可选的。灵敏度,特异性，正负预测值，并确定了使用ProsTAV可以避免进行活检的受试者。
结果：参与者的平均年龄（n=251）为67.4岁，平均PSA为5.90ng/ml，平均游离PSA为18.9%，PSA密度为0.14ng/ml。21.1%的受检者直肠指检异常,根据活检,显著PCa的患病率为47.8%.ProsTAV的ROC曲线下面积为0.7，敏感性为0.90（95％CI，0.85-0.95），特异性为0.27（95％CI，0.19-0.34）。阳性预测值和阴性预测值分别为0.53(95%CI,0.46-0.60)和0.74(95%CI,0.62-0.87),分别。ProsTAV可能减少了27％的活检，并显示了一些初步证据，表明诊断途径与MRI结合具有推定的益处。
结论：ProsTAV增加了PSA在3至10ng/ml之间的患者中显著PCa的预测能力，可以被认为是改善患者诊断途径的补充工具。
方法：一项针对前列腺特异性抗原（PSA）水平为3-10ng/ml且可疑PCa的患者的前瞻性观察性实用研究的初步数据。结果结合其他临床资料,所有患者均根据各中心的常规临床实践进行前列腺活检,而前列腺活检前的磁共振成像（MRI）是可选的。灵敏度,特异性，正负预测值，并确定了使用ProsTAV可以避免进行活检的受试者。
结果：参与者的平均年龄（n=251）为67.4岁，平均PSA为5.90ng/ml，平均游离PSA为18.9%，PSA密度为0.14ng/ml。21.1%的受检者直肠指检异常,根据活检,显著PCa的患病率为47.8%.ProsTAV的ROC曲线下面积为0.7，敏感性为0.90（95％CI，0.85-0.95），特异性为0.27（95％CI，0.19-0.34）。阳性预测值和阴性预测值分别为0.53(95%CI,0.46-0.60)和0.74(95%CI,0.62-0.87),分别。ProsTAV可能减少了27％的活检，并显示了一些初步证据，表明诊断途径与MRI结合具有推定的益处。
结论：ProsTAV增加了PSA在3至10ng/ml之间的患者中显著PCa的预测能力，可以被认为是改善患者诊断途径的补充工具。
