一项前瞻性、多中心、美国国家癌症研究所早期检测研究网络的 [-2]proPSA 研究：提高前列腺癌的检出率并与癌症侵袭性相关。
A prospective, multicenter, National Cancer Institute Early Detection Research Network study of [-2]proPSA: improving prostate cancer detection and correlating with cancer aggressiveness.
机构信息
Department of Pathology, Johns Hopkins Medical Institutions, 600 North Wolfe Street, Meyer B-125, Baltimore, MD 21287, USA.
出版信息
Cancer Epidemiol Biomarkers Prev. 2010 May;19(5):1193-200. doi: 10.1158/1055-9965.EPI-10-0007.
BACKGROUND
The free prostate-specific antigen (PSA) isoform, [-2]proPSA, has been shown to be associated with prostate cancer. The study objective was to characterize the clinical utility of serum [-2]proPSA for prostate cancer detection and assess its association with aggressive disease.
METHODS
From among 669 subjects in a prospective prostate cancer detection study at four National Cancer Institute Early Detection Research Network clinical validation centers, 566 were eligible. Serum PSA, free PSA, and [-2]proPSA were measured (Beckman Coulter Access 2 Analyzer).
RESULTS
Two hundred and forty-five (43%) of the 566 participants had prostate cancer on biopsy. At 70% specificity, the sensitivity of %[-2]proPSA ([-2]proPSA/fPSA) was 54% [95% confidence interval (CI), 48-61%; null hypothesis, 40%]. Including %[-2]proPSA in a multivariate prediction model incorporating PSA and %fPSA improved the performance (P<0.01). In the 2 to 4 ng/mL PSA range, %[-2]proPSA outperformed %fPSA (receiver operator characteristic-areas under the curve, 0.73 versus 0.61; P=0.01). At 80% sensitivity, %[-2]proPSA had significantly higher specificity (51.6%; 95% CI, 41.2-61.8%) than PSA (29.9%; 95% CI, 21.0-40.0%) and %fPSA (28.9%; 95% CI, 20.1-39.0%). In the 2 to 10 ng/mL PSA range, a multivariate model had significant improvement (area under the curve, 0.76) over individual PSA forms (P<0.01 to <0.0001). At 80% sensitivity, the specificity of %[-2]proPSA (44.9%; 95% CI, 38.4-51.5%) was significantly higher than PSA (30.8%; 95% CI, 24.9-37.1%) and relatively higher than %fPSA (34.6%; 95% CI, 28.5-41.4%). %[-2]proPSA increased with increasing Gleason score (P<0.001) and was higher in aggressive cancers (P=0.03).
CONCLUSIONS
In this prospective study, %[-2]proPSA showed potential clinical utility for improving prostate cancer detection and was related to the risk of aggressive disease.
IMPACT
The addition of %[-2]proPSA could affect the early detection of prostate cancer.
背景
游离前列腺特异性抗原（PSA）同工型 [-2]proPSA 已被证明与前列腺癌相关。本研究旨在描述血清 [-2]proPSA 对前列腺癌检测的临床应用价值，并评估其与侵袭性疾病的关系。
方法
在四个美国国家癌症研究所早期检测研究网络临床验证中心进行的前瞻性前列腺癌检测研究中，共有 669 名受试者，其中 566 名符合条件。使用贝克曼库尔特公司的 Access 2 分析仪检测血清 PSA、游离 PSA 和 [-2]proPSA。
结果
在 566 名参与者中，有 245 名（43%）经活检证实患有前列腺癌。在特异性为 70%时，%[-2]proPSA（[-2]proPSA/fPSA）的灵敏度为 54%（95%置信区间[CI]：48-61%；零假设为 40%）。在包含 PSA 和 %fPSA 的多变量预测模型中加入 %[-2]proPSA 可改善性能（P<0.01）。在 2 至 4ng/ml PSA 范围内，%[-2]proPSA 优于 %fPSA（接收者操作特征曲线下面积[ROC-AUC]：0.73 对 0.61；P=0.01）。当灵敏度为 80%时，%[-2]proPSA 的特异性（51.6%；95%CI：41.2-61.8%）明显高于 PSA（29.9%；95%CI：21.0-40.0%）和 %fPSA（28.9%；95%CI：20.1-39.0%）。在 2 至 10ng/ml PSA 范围内，多变量模型的 AUC 较单个 PSA 形式（P<0.01 至<0.0001）有显著改善。当灵敏度为 80%时，%[-2]proPSA 的特异性（44.9%；95%CI：38.4-51.5%）明显高于 PSA（30.8%；95%CI：24.9-37.1%），且相对高于 %fPSA（34.6%；95%CI：28.5-41.4%）。%[-2]proPSA 随 Gleason 评分的增加而升高（P<0.001），在侵袭性癌症中更高（P=0.03）。
结论
在这项前瞻性研究中，%[-2]proPSA 显示出改善前列腺癌检测的潜在临床应用价值，并与侵袭性疾病的风险相关。
影响
%[-2]proPSA 的加入可能会影响前列腺癌的早期检测。
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