Diagnostic Performance of PCA3 to Detect Prostate Cancer in Men with Increased Prostate Specific Antigen: A Prospective Study of 1,962 Cases
Diagnostic Performance of PCA3 to Detect Prostate Cancer in Men with Increased Prostate Specific Antigen: A Prospective Study of 1,962 Cases
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DOI：
10.1016/j.juro.2012.07.023
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发表时间：
2012-11-01
影响因子：
6.6
通讯作者：
Bostwick, David G.
中科院分区：
文献类型：
--
作者：
Crawford, E. David;Rove, Kyle O.;Bostwick, David G.
目的：前列腺癌的检测主要依赖于直肠指检异常或血清前列腺特异性抗原浓度升高。然而，低阳性预测值导致许多前列腺特异性抗原升高和/或可疑直肠指检活检阴性的男性。我们调查的PCA 3（前列腺癌基因3）尿检的价值在预测的可能性，诊断癌症活检前biopsiz.Materials和方法：我们进行了一项前瞻性的，社区为基础的临床试验，以评估PCA 3评分前任何活检。本试验在美国的50家泌尿外科诊所进行。在经直肠前列腺穿刺活检前，从1,962名血清前列腺特异性抗原升高（大于2.5 ng/ml）和/或直肠指检异常的男性中采集样本。研究样本（尿PCA 3和活检）由中心实验室处理和分析。结果：1,913份尿样（97.5%）可用于PCA 3检测。802例前列腺癌患者中，222例有高度前列腺上皮内瘤变或不典型小腺泡增生，可疑前列腺癌，889例为良性前列腺癌。传统的PCA 3临界值35将假阳性的数量从1，089减少到249，减少了77.1%。然而，假阴性（漏诊的癌症）从17例显著增加到413例，增加了2,300%以上。将PCA 3临界值降低至10，假阳性率降低35.4%，假阴性率仅增加5.6%。结论：尿PCA 3联合前列腺特异性抗原检测有可能显著减少不必要的前列腺活检次数。
Purpose: The detection of prostate cancer relies primarily on abnormal digital rectal examination or increased serum prostate specific antigen concentration. However, low positive predictive values result in many men with increased prostate specific antigen and/or suspicious digital rectal examination having a negative biopsy. We investigated the value of the PCA3 (prostate cancer gene 3) urine test in predicting the likelihood of diagnosis of cancer before biopsy.Materials and Methods: We performed a prospective, community based clinical trial to evaluate PCA3 score before any biopsy. This trial was conducted at 50 urology practices in the United States. Samples were obtained from 1,962 men with increased serum prostate specific antigen (greater than 2.5 ng/ml) and/or abnormal digital rectal examination before transrectal prostate needle biopsy. Study samples (urinary PCA3 and biopsies) were processed and analyzed by a central laboratory. Sensitivity-specificity analyses were conducted.Results: A total of 1,913 urine samples (97.5%) were adequate for PCA3 testing. Of 802 cases diagnosed with prostate cancer 222 had high grade prostatic intraepithelial neoplasia or atypical small acinar proliferation and were suspicious for cancer, whereas 889 cases were benign. The traditional PCA3 cutoff of 35 reduced the number of false-positives from 1,089 to 249, a 77.1% reduction. However, false-negatives (missed cancers) increased significantly from 17 to 413, an increase of more than 2,300%. Lowering the PCA3 cutoff to 10 reduced the number of false-positives 35.4% and false-negatives only increased 5.6%.Conclusions: Urinary PCA3 testing in conjunction with prostate specific antigen has the potential to significantly decrease the number of unnecessary prostate biopsies.