PCA3 molecular urine assay for prostate cancer in men undergoing repeat biopsy
PCA3 molecular urine assay for prostate cancer in men undergoing repeat biopsy
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DOI：
10.1016/j.urology.2006.12.014
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发表时间：
2007-03-01
期刊：
影响因子：
2.1
通讯作者：
Groskopf, Jack
中科院分区：
文献类型：
--
作者：
Marks, Leonard S.;Fradet, Yves;Groskopf, Jack
由于缺乏准确的诊断测试，血清前列腺特异性抗原（PSA）水平升高和前列腺活检结果阴性的男性面临困境。我们评估了潜在的实用性的研究前列腺癌基因3（PCA 3）尿液检测预测重复活检outcome.METHODS尿液收集后，直肠指检（每叶三笔）从233名男性血清PSA水平持续2.5 ng/mL或更高，至少有一个以前的阴性活检。标本采集于2004年4月至2006年1月。使用具有转录介导的扩增的高灵敏度定量测定来确定PCA 3评分。PCA 3评分预测活检结果的能力进行了评估，并与血清PSA levels.Results相比，RNA产量是足够的233人（即，提供信息的标本率为97%），从226尿样分析。在剩余的226例受试者中，重复活检显示60例（27%）前列腺癌。受试者工作特征曲线分析得出PCA 3评分的曲线下面积为0.68。相比之下，血清PSA的曲线下面积为0.52。使用PCA 3评分临界值35，检测灵敏度为58%，特异性为72%，比值比为3.6。在PCA 3评分小于5时，只有12%的男性在重复活检时患有前列腺癌;在PCA 3评分大于100时，活检阳性的风险为50%.CONCLUSION在接受重复前列腺活检以排除癌症的男性中，尿PCA 3评分在预测活检结果方面优于血清PSA测定上级。高特异性和高信息率提示PCA 3检测在前列腺癌诊断中具有重要作用。(c)2007年爱思唯尔公司
OBJECTIVES Men with elevated serum prostate-specific antigen (PSA) levels and negative prostate biopsy findings present a dilemma because of the lack of an accurate diagnostic test. We evaluated the potential utility of the investigational prostate cancer gene 3 (PCA3) urine assay to predict the repeat biopsy outcome.METHODS Urine was collected after digital rectal examination (three strokes per lobe) from 233 men with serum PSA levels persistently 2.5 ng/mL or greater and at least one previous negative biopsy. The specimens were collected from April 2004 to January 2006. The PCA3 scores were determined using a highly sensitive quantitative assay with transcription-mediated amplification. The ability of the PCA3 score to predict the biopsy outcome was assessed and compared with the serum PSA levels.RESULTS The RNA yield was adequate for analysis in the urine samples from 226 of 233 men (ie, the informative specimen rate was 97%). Repeat biopsy revealed prostate cancer in 60 (27%) of the of 226 remaining subjects. Receiver operating characteristic curve analysis yielded an area under the curve of 0.68 for the PCA3 score. In contrast, the area under the curve for serum PSA was 0.52. Using a PCA3 score cutoff of 35, the assay sensitivity was 58% and specificity 72%, with an odds ratio of 3.6. At PCA3 scores of less than 5, only 12% of men had prostate cancer on repeat biopsy; at PCA3 scores greater than 100, the risk of positive biopsy was 50%.CONCLUSIONS In men undergoing repeat prostate biopsy to rule out cancer, the urinary PCA3 score was superior to serum PSA determination for predicting the biopsy outcome. The high specificity and informative rate suggest that the PCA3 assay could have an important role in prostate cancer diagnosis. (c) 2007 Elsevier Inc.