Operating characteristics of prostate-specific antigen in men with an initial PSA level of 3.0 ng/mL or lower
Operating characteristics of prostate-specific antigen in men with an initial PSA level of 3.0 ng/mL or lower
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DOI：
10.1001/jama.294.1.66
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发表时间：
2005-07-06
影响因子：
120.7
通讯作者：
Coltman, CA
中科院分区：
文献类型：
--
作者：
Thompson, IM;Ankerst, DP;Coltman, CA
背景四分之三的美国男性年龄超过50岁的前列腺特异性抗原（PSA）的前列腺癌screened for prostate cancer.Objective估计的受试者工作特征（ROC）曲线为PSA.Design，设置，和参与者计算的PSA ROC曲线在安慰剂组的前列腺癌预防试验，一个随机的，前瞻性的研究，从1993年至2003年在221个美国中心。研究对象为18882名年龄≥ 55岁、无前列腺癌、PSA水平≤ 3.0 ng/mL、直肠指检结果正常的健康男性，随访7年，每年进行PSA测量和直肠指检。如果PSA水平超过4.0 ng/mL或直肠检查结果异常，建议进行前列腺活检。研究参与7年后，建议所有无癌男性进行研究结束时前列腺活检。主要结果测量PSA用于前列腺癌检测的操作特征，包括敏感性、特异性和ROC曲线。结果在安慰剂组的8575名男性中，在同一年至少有一次PSA测量和直肠指检，5587例（65.2%）至少进行了1次活检;其中1225例（21.9%）被诊断为前列腺癌。在记录的1213例Gleason分级的癌症中，250例（20.6%）为Gleason 7级或以上，57例（4.7%）为Gleason 8级或以上。PSA区分任何前列腺癌与无癌症、Gleason 7级或更高级别癌症与无或更低级别癌症以及Gleason 8级或更高级别癌症与无或更低级别癌症的ROC曲线下面积（AUC）为0.678（95%置信区间[CI]，0.666-0.689）、0.782（95% CI，0.748-0.816）和0.827（95% CI，0.761-0.893）（所有P值
Context Three fourths of US men older than 50 years have been screened with prostate-specific antigen (PSA) for prostate cancer.Objective To estimate the receiver operating characteristic (ROC) curve for PSA.Design, Setting, and Participants Calculation of PSA ROC curves in the placebo group of the Prostate Cancer Prevention Trial, a randomized, prospective study conducted from 1993 to 2003 at 221 US centers. Participants were 18 882 healthy men aged 55 years or older without prostate cancer and with PSA levels less than or equal to 3.0 ng/mL and normal digital rectal examination results, followed up for 7 years with annual PSA measurement and digital rectal examination. If PSA level exceeded 4.0 ng/mL or rectal examination result was abnormal, a prostate biopsy was recommended. After 7 years of study participation, an end-of-study prostate biopsy was recommended in all cancer-free men.Main Outcome Measures Operating characteristics of PSA for prostate cancer detection, including sensitivity, specificity, and ROC curve.Results Of 8575 men in the placebo group with at least 1 PSA measurement and digital rectal examination in the same year, 5587 (65.2%) had had at least 1 biopsy; of these, 1225 (21.9%) were diagnosed with prostate cancer. Of 1213 cancers with Gleason grade recorded, 250 (20.6%) were Gleason grade 7 or greater and 57 (4.7%) were Gleason grade 8 or greater. The areas under the ROC curve (AUC) for PSA to discriminate any prostate cancer vs no cancer, Gleason grade 7 or greater cancer vs no or lower-grade cancer, and Gleason grade 8 or greater cancer vs no or lower-grade cancer were 0.678 (95% confidence interval [CI], 0.666-0.689), 0.782 (95% Cl, 0.748-0.816), and 0.827 (95% Cl, 0.761-0.893), respectively (all P values