Department of Urology, Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, OH, USA.
Cleveland Diagnostics, Cleveland, OH, USA.
Eur Urol. 2017 Dec;72(6):942-949. doi: 10.1016/j.eururo.2017.03.025. Epub 2017 Apr 7.
IsoPSA is a serum-based assay that predicts prostate cancer (PCa) risk by partitioning isoforms of prostate-specific antigen (PSA) with an aqueous two-phase reagent.
To determine the diagnostic accuracy of IsoPSA in identifying the presence or absence of PCa and the presence of high-grade disease in a contemporary biopsy cohort.
DESIGN, SETTING, AND PARTICIPANTS: Multicenter prospective study of 261 men scheduled for prostate biopsy at five academic and community centers in the USA enrolled between August 2015 and December 2016.
Performance of the IsoPSA assay.
Discrimination power was evaluated using receiver operating characteristic (ROC) analysis. The outcome of the IsoPSA assay was transformed into risk probability using logistic regression. Decision curve analysis (DCA) was used to compare the net benefit of IsoPSA against other clinical protocols.
The overall prevalence was 53% for any PCa and 34% for high-grade PCa. The area under the ROC curve was 0.79 for any cancer versus none and 0.81 for high-grade PCa versus low-grade PCa/benign histology. In this preliminary study, DCA revealed a superior net benefit of IsoPSA against no biopsy, all biopsy, and the modified Prostate Cancer Prevention Trial Risk Calculator 2.0. At a cutoff selected to recommend biopsy, IsoPSA demonstrated a 48% reduction in false-positive biopsies; at a cutoff selected to identity men at low risk of high-grade disease, there was a 45% reduction in the false-positive rate.
The structure-based IsoPSA assay outperformed concentration-based PSA measurement, and provided a net benefit against other protocols. Once validated, clinical use of IsoPSA could significantly reduce unnecessary biopsies while identifying patients needing treatment.
The IsoPSA assay outperformed prostate-specific antigen in predicting the overall risk of prostate cancer and the risk of clinically significant cancer in a preliminary study. The IsoPSA assay could assist in determining the need for prostate biopsy for patients.
IsoPSA 是一种基于血清的检测方法，通过使用双相试剂对前列腺特异性抗原（PSA）的同工型进行分区，从而预测前列腺癌（PCa）的风险。
确定 IsoPSA 在识别 PCa 存在与否以及识别高级别疾病存在的诊断准确性，该检测是在当代活检队列中进行的。
设计、设置和参与者：这项多中心前瞻性研究纳入了 2015 年 8 月至 2016 年 12 月期间在美国 5 个学术和社区中心计划进行前列腺活检的 261 名男性。
IsoPSA 检测的性能。
使用接收者操作特征（ROC）分析评估鉴别能力。通过逻辑回归将 IsoPSA 检测结果转化为风险概率。决策曲线分析（DCA）用于比较 IsoPSA 与其他临床方案的净获益。
任何 PCa 的总体患病率为 53%，高级别 PCa 的患病率为 34%。ROC 曲线下面积（AUC）为 0.79（任何癌症与无癌症相比）和 0.81（高级别 PCa 与低级别 PCa/良性组织学相比）。在这项初步研究中，DCA 显示 IsoPSA 相对于不活检、所有活检和改良的前列腺癌预防试验风险计算器 2.0 具有更高的净获益。在选择推荐活检的切点时，IsoPSA 显示假阳性活检减少了 48%；在选择识别低高级别疾病风险的男性的切点时，假阳性率降低了 45%。
基于结构的 IsoPSA 检测在预测总体前列腺癌风险和临床显著癌症风险方面优于基于浓度的 PSA 测量，并提供了优于其他方案的净获益。一旦得到验证，IsoPSA 的临床应用可以显著减少不必要的活检，同时识别需要治疗的患者。
在一项初步研究中，IsoPSA 检测在预测总体前列腺癌风险和临床显著癌症风险方面优于前列腺特异性抗原。IsoPSA 检测可以帮助确定患者是否需要进行前列腺活检。
