Department of Urology, Hospital Universitario Reina Sofía, Universidad de Córdoba, IMIBIC, Córdoba, Spain.
LYX Urology Institute, Madrid, Spain.
World J Urol. 2024 Jul 10;42(1):395. doi: 10.1007/s00345-024-05098-8.
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).
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.
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.
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.
评估 ProsTAV（一种基于端粒相关变量（TAV）测量的血液检测）的临床性能，以支持在诊断可疑前列腺癌（PCa）时进行活检决策。
这是一项前瞻性观察性实用研究的初步数据，研究对象为前列腺特异性抗原（PSA）水平在 3-10ng/ml 之间且疑似患有 PCa 的患者。结果与其他临床数据相结合，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）则是可选的。确定了 ProsTAV 的敏感性、特异性、阳性和阴性预测值，以及可以通过 ProsTAV 避免进行活检的患者。
参与者（n=251）的平均年龄为 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%的受试者直肠指检异常，根据活检结果，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%置信区间，0.85-0.95），特异性为 0.27（95%置信区间，0.19-0.34）。阳性和阴性预测值分别为 0.53（95%置信区间，0.46-0.60）和 0.74（95%置信区间，0.62-0.87）。ProsTAV 可减少 27%的活检次数，并结合 MRI 显示出在诊断途径中具有潜在获益的初步证据。
ProsTAV 提高了 PSA 在 3-10ng/ml 之间的患者中显著 PCa 的预测能力，可被视为改善患者诊断途径的一种补充工具。
