CHU Henri Mondor, Paris, France.
J Urol. 2011 Jun;185(6):2119-25. doi: 10.1016/j.juro.2011.01.075. Epub 2011 Apr 15.
We evaluated the clinical utility of the PCA3 assay in guiding initial biopsy decisions in prostate cancer.
A European, prospective, multicenter study enrolled men with a serum total prostate specific antigen of 2.5 to 10 ng/ml scheduled for initial biopsy. After digital rectal examination first catch urine was collected. PCA3 scores were determined using the PROGENSA(®) PCA3 assay and compared to biopsy outcome. The diagnostic accuracy of PCA3 was compared to total prostate specific antigen, prostate specific antigen density and %free prostate specific antigen.
In 516 men the positive biopsy rate was 40%. An increasing PCA3 score corresponded with an increasing probability of a positive biopsy. The mean PCA3 score was higher in men with a positive vs a negative biopsy (69.6 vs 31.0, median 50 vs 18, p <0.0001). The PCA3 score was independent of age, total prostate specific antigen and prostate volume. The PCA3 score (cutoff of 35) had a sensitivity of 64% and specificity of 76%. ROC analysis showed a significantly higher AUC for the PCA3 score vs total prostate specific antigen, prostate specific antigen density and %free prostate specific antigen. The PCA3 score was significantly higher in men with biopsy Gleason score 7 or greater vs less than 7, greater than 33% vs 33% or fewer positive cores and significant vs indolent prostate cancer. Inclusion of PCA3 in multivariable models increased their predictive accuracy by up to 5.5%.
The PROGENSA PCA3 assay can aid in guiding biopsy decisions. It is superior to total prostate specific antigen, prostate specific antigen density and %free prostate specific antigen in predicting initial biopsy outcome, and may be indicative of prostate cancer aggressiveness.
我们评估 PCA3 检测在指导前列腺癌初始活检决策中的临床应用价值。
一项欧洲前瞻性多中心研究纳入了血清总前列腺特异抗原（PSA）为 2.5 至 10ng/ml、拟行初始活检的男性患者。在进行直肠指检前，先收集首次尿液样本。使用 PROGENSA(®) PCA3 检测试剂盒测定 PCA3 评分，并与活检结果进行比较。比较 PCA3 与总 PSA、PSA 密度和 %游离 PSA 的诊断准确性。
在 516 例男性患者中，阳性活检率为 40%。随着 PCA3 评分的增加，阳性活检的概率也随之增加。与阴性活检相比，阳性活检患者的平均 PCA3 评分更高（69.6 对 31.0，中位数 50 对 18，P<0.0001）。PCA3 评分与年龄、总 PSA 和前列腺体积无关。PCA3 评分（临界值 35）的敏感度为 64%，特异度为 76%。ROC 分析显示，PCA3 评分的 AUC 显著高于总 PSA、PSA 密度和 %游离 PSA。与活检 Gleason 评分<7 相比，评分≥7 的患者 PCA3 评分更高，阳性活检核心数>33%比≤33%更高，侵袭性前列腺癌比惰性前列腺癌更高。在多变量模型中纳入 PCA3 可使预测准确性提高多达 5.5%。
PROGENSA PCA3 检测可辅助活检决策。与总 PSA、PSA 密度和 %游离 PSA 相比，它在预测初始活检结果方面更具优势，并且可能提示前列腺癌的侵袭性。
