PCA3 Molecular Urine Test as a Predictor of Repeat Prostate Biopsy Outcome in Men with Previous Negative Biopsies: A Prospective Multicenter Clinical Study
PCA3 Molecular Urine Test as a Predictor of Repeat Prostate Biopsy Outcome in Men with Previous Negative Biopsies: A Prospective Multicenter Clinical Study
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DOI：
10.1016/j.juro.2013.02.018
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发表时间：
2013-07-01
影响因子：
6.6
通讯作者：
Ward, John F.
中科院分区：
文献类型：
--
作者：
Gittelman, Marc C.;Hertzman, Bernard;Ward, John F.
目的：我们评估了 PROGENSA (R) PCA3 检测在预测重复前列腺活检结果方面的临床实用性。材料和方法：在 14 个中心招募了至少 1 次既往前列腺活检呈阴性且根据最佳临床判断计划进行重复前列腺活检的男性。在使用 12 个或更多芯的扩展模板经直肠活检之前收集全血和直肠指检后尿样。通过逻辑回归分析评估尿液 PCA3 评分和活检结果，其中还包括年龄、种族、血清前列腺特异性抗原、临床分期、前列腺癌家族史和既往阴性活检次数。 结果：共有 466 名男性参与研究，前列腺癌检出率为 21.9%。 PCA3 评分截止值为 25 时，敏感性为 77.5%，特异性为 57.1%，阴性和阳性预测值分别为 90% 和 33.6%。在多变量逻辑回归中，PCA3 得分低于 25 分的男性重复活检呈阴性的可能性是得分为 25 或更高的男性的 4.56 倍。 PCA3评分显着提高了逻辑回归模型的预测准确性。与没有 PCA3 评分的模型相比，在 90% 的灵敏度下，将 PCA3 评分添加到模型中可以提高特异性，阳性和阴性预测值分别提高 22.6%、6.4% 和 7.1%。 结论：PCA3 评分补充了血清前列腺特异性抗原和其他临床信息，可以更准确地预测重复活检结果。因此，它为临床医生和患者提供独立的、临床上有用的信息，以做出更明智的重复活检决策。
Purpose: We evaluated the clinical usefulness of the PROGENSA (R) PCA3 Assay for predicting repeat prostate biopsy outcome.Materials and Methods: Men with at least 1 prior negative prostate biopsy who were scheduled for repeat prostate biopsy based on best clinical judgment were enrolled at 14 centers. Whole blood and post-digital rectal examination urine samples were collected before extended template transrectal biopsy with 12 or more cores. Urinary PCA3 scores and biopsy outcomes were assessed by logistic regression analysis, which also included age, race, serum prostate specific antigen, clinical stage, family history of prostate cancer and the number of previous negative biopsy sessions.Results: A total of 466 men were included in study and prostate cancer was identified in 21.9%. A PCA3 score cutoff of 25 yielded 77.5% sensitivity, 57.1% specificity, and negative and positive predictive values of 90% and 33.6%, respectively. On multivariable logistic regression men with a PCA3 score of less than 25 were 4.56 times as likely to have a negative repeat biopsy as men with a score of 25 or greater. PCA3 score significantly increased the predictive accuracy of the logistic regression model. At 90% sensitivity adding the PCA3 score to the model increased specificity, and positive and negative predictive values by 22.6%, 6.4% and 7.1%, respectively, relative to the model without the PCA3 score.Conclusions: The PCA3 score supplements serum prostate specific antigen and other clinical information to provide more accurate prediction of repeat biopsy outcome. Thus, it provides clinicians and patients with independent, clinically useful information to make more informed repeat biopsy decisions.