Baden Jonathan, Green George, Painter Jennifer, Curtin Katy, Markiewicz Jadwiga, Jones Jennifer, Astacio Tara, Canning Susan, Quijano Jedidiah, Guinto Wilson, Leibovich Bradley C, Nelson Joel B, Vargo Janet, Wang Yixin, Wuxiong Cao
Veridex, LLC, Raritan, New Jersey, USA.
J Urol. 2009 Sep;182(3):1186-93. doi: 10.1016/j.juro.2009.05.003. Epub 2009 Jul 21.
Prostate specific antigen tests have low specificity, which frequently results in unnecessary biopsy and typically limits screening to patients with prostate specific antigen greater than 4.0 ng/ml. We evaluated an investigational prostate cancer methylation specific polymerase chain reaction assay that detects aberrant methylation in 3 markers (GSTP1, RARbeta2 and APC) that indicate the presence of prostate cancer.
The assay was evaluated in 337 post-digital rectal examination urine samples (178 cancer and 159 noncancer) collected prospectively at a total of 9 clinical sites. Samples were processed wholly or after division into equal portions. Subject prostate specific antigen was 2.0 to 10.0 ng/ml. All subjects underwent transrectal ultrasound guided needle biopsy with 6 or greater cores sampled. Detection of 1 or greater markers indicated positivity.
Methylation specific polymerase chain reaction assay performance was better in whole than in divided urine cohorts (p = 0.035). Assay AUC was 0.72 in the whole urine cohort and 0.67 in the combined population. These values were higher than those of prostate specific antigen alone using 4.0 ng/ml as the cutoff (p = 0.00 and 0.01, respectively). Moreover, the assay together with the Prostate Cancer Prevention Trial risk calculator or a standard nomogram significantly improved AUC in the whole urine cohort and the combined population vs predictive algorithms alone (p <0.05). Assay positive predictive value was 54% in whole urine cohort with prostate specific antigen 2.0 to 4.0 ng/ml and negative predictive value was 87% with prostate specific antigen 4.1 to 10.0 ng/ml. Assay positive predictive value was higher in subjects with all 3 methylation markers positive.
These data demonstrate that this investigational assay used in conjunction with current screening algorithms may potentially add value to the biopsy decision making process.
前列腺特异性抗原检测的特异性较低，这常常导致不必要的活检，并且通常将筛查局限于前列腺特异性抗原大于4.0 ng/ml的患者。我们评估了一种研究性的前列腺癌甲基化特异性聚合酶链反应检测方法，该方法可检测3种标志物（谷胱甘肽S-转移酶P1、视黄酸受体β2和腺瘤性息肉病基因）中的异常甲基化，这些标志物表明前列腺癌的存在。
在总共9个临床地点前瞻性收集的337份直肠指检后尿液样本（178份癌症样本和159份非癌症样本）中对该检测方法进行评估。样本全部处理或分成等份后处理。受试者的前列腺特异性抗原为2.0至10.0 ng/ml。所有受试者均接受经直肠超声引导下的穿刺活检，采集6个或更多的组织芯。检测到1个或更多标志物表明为阳性。
甲基化特异性聚合酶链反应检测方法在完整尿液队列中的表现优于分割后的尿液队列（p = 0.035）。在完整尿液队列中检测方法的曲线下面积（AUC）为0.72，在合并人群中为0.67。这些值高于以4.0 ng/ml为临界值单独使用前列腺特异性抗原时的值（分别为p = 0.00和0.01）。此外，该检测方法与前列腺癌预防试验风险计算器或标准列线图联合使用时，在完整尿液队列和合并人群中的AUC显著高于单独使用预测算法时（p <0.05）。在前列腺特异性抗原为2.0至至4.0 ng/ml的完整尿液队列中，检测方法的阳性预测值为54%，在前列腺特异性抗原为4.1至10.0 ng/ml时阴性预测值为87%。在所有3种甲基化标志物均为阳性的受试者中，检测方法的阳性预测值更高。
这些数据表明，这种研究性检测方法与当前的筛查算法联合使用可能会为活检决策过程增添价值。
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