Can Urinary PCA3 Supplement PSA in the Early Detection of Prostate Cancer?
Can Urinary PCA3 Supplement PSA in the Early Detection of Prostate Cancer?
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DOI：
10.1200/jco.2013.52.8505
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发表时间：
2014-12-20
影响因子：
45.3
通讯作者：
Sanda, Martin G.
中科院分区：
文献类型：
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作者：
Wei, John T.;Feng, Ziding;Sanda, Martin G.
目的由于前列腺特异性抗原(PSA)的敏感性和特异性有限，其作为筛查工具的广泛应用引起了人们对低风险前列腺癌的过度诊断和对高级别前列腺癌的低估的担忧。为了改进早期检测活检的决策，美国国家癌症研究所进行了一项前瞻性验证试验，以评估前列腺癌抗原3(PCA3)尿液分析在前列腺癌筛查男性中的诊断性能。患者和方法共有来自11个中心的859名男性(平均年龄62岁)在2009年12月至2011年6月期间接受前列腺癌诊断。主要结果是评估PCA3能否提高首次活检的阳性预测值(PPV)和重复活检的阴性预测值(NPV)。结果对于任何癌症的检测，首次活检组的阳性预测值为80%(95%可信区间，72%~86%)，重复活检组的NPV为88%(95%可信区间，81%~93%)。将PCA3添加到个体风险估计模型(包括年龄、种族/民族、既往活检、PSA和直肠指检)改善了癌症和高级别癌症的分层。结论这些数据独立地支持PCA3在减轻接受重复前列腺活检的男性的前列腺活检负担方面的作用。对于初诊的患者，较高的PCA3评分(>；60)显著增加了首次前列腺癌活检术识别癌症的概率。(C)美国临床肿瘤学会2014年
PurposeGiven the limited sensitivity and specificity of prostate-specific antigen (PSA), its widespread use as a screening tool has raised concerns for the overdiagnosis of low-risk and the underdiagnosis of high-grade prostate cancer. To improve early-detection biopsy decisions, the National Cancer Institute conducted a prospective validation trial to assess the diagnostic performance of the prostate cancer antigen 3 (PCA3) urinary assay for the detection of prostate cancer among men screened with PSA.Patients and MethodsIn all, 859 men (mean age, 62 years) from 11 centers scheduled for a diagnostic prostate biopsy between December 2009 and June 2011 were enrolled. The primary outcomes were to assess whether PCA3 could improve the positive predictive value (PPV) for an initial biopsy (at a score > 60) and the negative predictive value (NPV) for a repeat biopsy (at a score < 20).ResultsFor the detection of any cancer, PPV was 80% (95% CI, 72% to 86%) in the initial biopsy group, and NPV was 88% (95% CI, 81% to 93%) in the repeat biopsy group. The addition of PCA3 to individual risk estimation models (which included age, race/ethnicity, prior biopsy, PSA, and digital rectal examination) improved the stratification of cancer and of high-grade cancer.ConclusionThese data independently support the role of PCA3 in reducing the burden of prostate biopsies among men undergoing a repeat prostate biopsy. For biopsy-naive patients, a high PCA3 score (> 60) significantly increases the probability that an initial prostate biopsy will identify cancer. (C) 2014 by American Society of Clinical Oncology