Gen-Probe Incorporated, San Diego, California, USA.
J Urol. 2010 Nov;184(5):1947-52. doi: 10.1016/j.juro.2010.06.098. Epub 2010 Sep 17.
We determined the performance of PCA3 alone and in the presence of other covariates as an indicator of contemporaneous and future prostate biopsy results in a population with previous negative biopsy and increased serum prostate specific antigen.
Urine PCA3 scores were determined before year 2 and year 4 biopsies from patients in the placebo arm of the REDUCE trial, a prostate cancer risk reduction study evaluating men with moderately increased serum prostate specific antigen results and negative biopsy at baseline. PCA3, serum prostate specific antigen and percent free prostate specific antigen results were correlated with biopsy outcome via univariate logistic regression and ROC analyses. Multivariate logistic regression was also performed including these biomarkers together with prostate volume, age and family history.
PCA3 scores were measurable from 1,072 of 1,140 subjects (94% informative rate). PCA3 scores were associated with positive biopsy rate (p <0.0001) and correlated with biopsy Gleason score (p = 0.0017). PCA3 AUC of 0.693 was greater than serum prostate specific antigen (0.612, p = 0.0077 vs PCA3). The multivariate logistic regression model yielded an AUC of 0.753 and exclusion of PCA3 from the model decreased AUC to 0.717 (p = 0.0009). PCA3 at year 2 was a significant predictor of year 4 biopsy outcome (AUC 0.634, p = 0.0002), whereas serum prostate specific antigen and free prostate specific antigen were not predictive (p = 0.3281 and 0.6782, respectively).
PCA3 clinical performance was validated in the largest repeat biopsy study to date. Increased PCA3 scores indicated increased risk of contemporaneous cancers and predicted future biopsy outcomes. Use of PCA3 in combination with serum prostate specific antigen and other risk factors significantly increased diagnostic accuracy.
我们评估了 PCA3 单独以及与其他协变量联合时，在既往前列腺活检阴性且血清前列腺特异抗原（PSA）升高的人群中，作为同期和未来前列腺活检结果的指标的性能。
我们测定了 REDUCE 试验安慰剂组中患者在第 2 年和第 4 年前列腺活检前的尿 PCA3 评分，该研究为前列腺癌风险降低研究，评估了基线时血清 PSA 水平中度升高且前列腺活检阴性的男性。通过单变量逻辑回归和 ROC 分析，将 PCA3、血清 PSA 和游离 PSA 百分比与活检结果进行相关性分析。还进行了多变量逻辑回归分析，将这些生物标志物与前列腺体积、年龄和家族史一起纳入分析。
1072 名（94%）可测量到 PCA3 评分的受试者中，1140 名受试者（94%）可测量到 PCA3 评分。PCA3 评分与阳性活检率相关（p<0.0001），并与活检 Gleason 评分相关（p=0.0017）。PCA3 的 AUC 为 0.693，大于血清 PSA（0.612，p=0.0077 与 PCA3 相比）。多变量逻辑回归模型的 AUC 为 0.753，将 PCA3 排除在模型之外后 AUC 降至 0.717（p=0.0009）。第 2 年的 PCA3 是第 4 年活检结果的重要预测因素（AUC 0.634，p=0.0002），而血清 PSA 和游离 PSA 没有预测价值（p=0.3281 和 0.6782）。
PCA3 的临床性能在迄今为止最大的重复活检研究中得到了验证。PCA3 评分升高提示同期癌症风险增加，并预测未来的活检结果。将 PCA3 与血清 PSA 和其他危险因素联合使用，可显著提高诊断准确性。
