Gen-Probe Incorporated, San Diego, California, USA.
Urology. 2011 Aug;78(2):380-5. doi: 10.1016/j.urology.2011.03.033.
To examine the ability of the urinary prostate cancer gene 3 (PCA3) assay to predict biopsy-detected cancers in men receiving dutasteride in the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) study cohort.
Urine and serum samples from 930 men in the active arm were acquired at years 2 and 4 of the biopsy visits. In addition to univariate logistic regression and receiver operating characteristic analysis, multivariate analysis for association with biopsy outcome was performed for PCA3 score in the presence of serum prostate-specific antigen (PSA), age, prostate volume, and family history of prostate cancer.
At year 2, the univariate PCA3 score area under the receiver operating characteristic curve (AUC) was 0.668 versus 0.603 for PSA. At year 4, the PCA3 assay significantly predicted the biopsy outcome (AUC 0.628, 95% confidence interval 0.556-0.700), and the PSA level was not predictive (AUC 0.556, 95% confidence interval 0.469-0.642). The year 2 multivariate model yielded an AUC of 0.712. Removing the PCA3 score decreased the AUC to 0.660 (P = .0166 vs the full model). The median PCA3 scores in the dutasteride arm were not different from those in the 1072 men in the placebo arm (16.2 and 17.2 at year 2, P = .1755; and 18.8 and 18.1 at year 4, P = .2340, respectively). However, the PSA values were reduced >50% in the dutasteride arm at both visits (both P < .0001 vs placebo). At a PCA3 score cutoff of 35, the sensitivity and specificity were equivalent between the 2 arms.
In the present study, the PCA3 assay outperformed PSA for cancer detection in men undergoing dutasteride treatment and improved the diagnostic accuracy when combined with the PSA level and other clinical variables. In addition, no adjustment in PCA3 score was needed to yield equivalent clinical performance between the dutasteride and placebo arms. These findings are particularly important in light of the potential role of dutasteride for prostate cancer chemoprevention.
在接受度他雄胺治疗的 REDUCE 研究队列中，检测尿前列腺癌基因 3（PCA3）检测对活检检出癌的预测能力。
在活检访视的第 2 年和第 4 年，采集了 930 名活性组男性的尿液和血清样本。除了单变量逻辑回归和接收者操作特征分析外，还针对 PCA3 评分与活检结果的相关性进行了多元分析，同时考虑了血清前列腺特异性抗原（PSA）、年龄、前列腺体积和前列腺癌家族史。
在第 2 年，单变量 PCA3 评分的接收者操作特征曲线下面积（AUC）为 0.668，PSA 为 0.603。在第 4 年，PCA3 检测法显著预测了活检结果（AUC 0.628，95%置信区间 0.556-0.700），而 PSA 水平无预测性（AUC 0.556，95%置信区间 0.469-0.642）。第 2 年的多元模型得出 AUC 为 0.712。去除 PCA3 评分后，AUC 降至 0.660（与完整模型相比，P =.0166）。度他雄胺组的中位 PCA3 评分与安慰剂组的 1072 名男性的评分无差异（第 2 年分别为 16.2 和 17.2，P =.1755；第 4 年分别为 18.8 和 18.1，P =.2340）。然而，在两次访视时，度他雄胺组的 PSA 值均降低了>50%（均 P <.0001 与安慰剂相比）。当 PCA3 评分截点为 35 时，2 组的敏感性和特异性相当。
在本研究中，在接受度他雄胺治疗的男性中，PCA3 检测在癌症检测方面优于 PSA，并与 PSA 水平和其他临床变量相结合时提高了诊断准确性。此外，在度他雄胺组和安慰剂组之间，无需调整 PCA3 评分即可获得等效的临床效果。鉴于度他雄胺在前列腺癌化学预防中的潜在作用，这些发现尤为重要。
