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An expanded biomarker panel for the detection of prostate cancer from urine DNA

机译：一种膨胀生物标志物，用于检测来自尿液DNA前列腺癌

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Prostate cancer diagnosis using the PSA test remains controversial because of overdiagnosis and overtreatment of potentially indolent cancers. There remains a need to increase the diagnostic lead time and to target treatment to patients with significant disease. One possible approach to overcome the limitations of PSA is to screen men for the molecular signature of early PCA, monitor the rate of disease progression and target treatment to patients who are likely to benefit from it. Such an approach requires a large panel of markers that define a molecular clock for PCA. We recently developed a panel of 19 markers for the non-invasive detection of PCA from urine DNA. It raised the possibility that additional methylation markers could be successfully analyzed from urine DNA, a prerequisite for increasing the diagnostic lead time and enabling disease monitoring. We developed semi-quantitative polymerase chain reaction assays for 13 additional markers and determined their methylation status in 150 urine DNAs from 94 patients with elevated PSA. Eighty five samples were obtained following DRE and 65 samples were from first void. We combined the data of the 13 new markers with the previously reported 19 markers and calculated the sensitivity, specificity, negative and positive predictive values at every threshold from one to 32 positive markers. Using 10of32 positive markers as the threshold to recommend a biopsy yields a sensitivity of 81% (95% CI 0.68-0.93) and 93% (95% CI 0.84-1.02) and a specificity of 76% (95% CI 0.63-0.88) and 77% (95% CI 0.63-0.91) from DRE and FV DNA, respectively. The PPV was 71% and 77% and the NPV was 85% and 93% from DRE and FV, respectively. This study shows that large marker panels can be analyzed from urine DNA without loss of sensitivity or specificity. Using 32 markers improved the stratification of patients undergoing screening for PCA particularly for patients below the 10of32 threshold. The results show the utility of larger biomarker panels for PCA diagnosis and suggest that the development of the panels needed to monitor disease progression could be successfully accomplished.
机译：使用PSA测试的前列腺癌诊断由于过度输入和潜在的惰性癌症过度诊断和过度处理仍存在争议。仍然需要增加诊断时间和针对具有显着疾病患者的靶向治疗。克服PSA局限性的一种可能的方法是筛选男性，用于早期PCA的分子签名，监测可能从中受益的患者的疾病进展和目标治疗。这种方法需要一个大号标记，用于为PCA定义分子时钟。我们最近开发了一个19个标记，用于来自尿液DNA的非侵入性检测PCA。它提出了额外的甲基化标志物可以从尿液DNA成功分析额外的甲基化标志物，用于增加诊断促进时间和使疾病监测的先决条件。我们开发了13种附加标记的半定量聚合酶链反应测定，并在94例PSA升高的患者中确定了150例尿液DNA中的甲基化状态。在DRE和65个样品中获得八十五个样品来自第一空隙。我们将13个新标记的数据与先前报道的19个标记组合，并计算了从一到32个阳性标记的每个阈值下计算的灵敏度，特异性，阴性和阳性预测值。使用10oF32阳性标记作为推荐活检的阈值产生81％（95％CI 0.68-0.93）的敏感性，93％（95％CI 0.84-1.02），特异性为76％（95％CI 0.63-0.88）分别来自DRE和FV DNA的77％（95％CI 0.63-0.91）。 PPV分别为71％，77％，分别与DRE和Fv的NPV分别为85％和93％。本研究表明，可以从尿液DNA分析大型标记面板而不会损失敏感性或特异性。使用32个标记改善了接受PCA筛查的患者的分层，特别是对于10oF32阈值以下的患者。结果表明，较大的PCA诊断较大生物标志物面板的效用，并表明可以成功完成监测疾病进展所需的面板的开发。

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