Clinical Utility of the PCA3 Urine Assay in European Men Scheduled for Repeat Biopsy
Clinical Utility of the PCA3 Urine Assay in European Men Scheduled for Repeat Biopsy
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DOI：
10.1016/j.eururo.2008.06.071
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发表时间：
2008-11-01
期刊：
影响因子：
23.4
通讯作者：
Schalken, Jack A.
中科院分区：
文献类型：
--
作者：
Haese, Alexander;de la Taille, Alexandre;Schalken, Jack A.
背景资料：前列腺癌基因3（PCA3）检测已显示出作为前列腺癌（pCA）诊断辅助手段的前景，可用于识别阳性（重复）活检概率高的男性。目的：本研究评估了PROGENSA PCA3检测的临床实用性。设计、设置和参与者：本欧洲前瞻性、多中心研究招募了计划进行重复活检的1次或2次阴性活检的男性。测量：直肠指检（DRE）后，收集首段尿，测定PCA3 mRNA浓度，计算PCA3评分。将PCA3评分与活检结果进行比较。PCA3检测的诊断准确性与游离前列腺特异性抗原（%fPSA）的百分比进行比较。结果和局限性：在463名男性中，阳性重复活检率为28%。PCA3评分越高，重复活检阳性的可能性越大。PCA3评分（临界值为35）的诊断准确性高于%fPSA（临界值为25%）。PCA3评分与既往活检次数、年龄、前列腺体积和总前列腺特异性抗原（PSA）水平无关。此外，前列腺高级别上皮内瘤变（HGPIN）患者的PCA3评分显著高于无HGPIN患者，临床分期T2与T1，Gleason评分≥ 7与
Background: The Prostate CAncer gene 3 (PCA3) assay has shown promise as an aid in prostate cancer (pCA) diagnosis in identifying men with a high probability of a positive (repeat) biopsy.Objective: This study evaluated the clinical utility of the PROGENSA PCA3 assay.Design, setting, and participants: This European prospective, multicentre study enrolled men with one or two negative biopsies scheduled for repeat biopsy.Measurements: After digital rectal examination (DRE), first-catch urine was collected to measure PCA3 mRNA concentration and to calculate the PCA3 score. The PCA3 score was compared to biopsy outcome. The diagnostic accuracy of the PCA3 assay was compared to percent of free prostate-specific antigen (%fPSA).Results and limitations: in 463 men, the positive repeat biopsy rate was 28%. The higher the PCA3 score, the greater the probability of a positive repeat biopsy. The PCA3 score (cut-off of 35) had a greater diagnostic accuracy than %fPSA (cut-off of 25%). The PCA3 score was independent of the number of previous biopsies, age, prostate volume, and total prostate-specific antigen (PSA) level. Moreover, the PCA3 score was significantly higher in men with high-grade prostate intraepithelial neoplasia (HGPIN) versus those without HGPIN, clinical stage T2 versus T1, Gleason score >= 7 versus