Department of Urology, Erasmus MC, University Medical Centre, Rotterdam, The Netherlands.
Eur Urol. 2011 Apr;59(4):498-505. doi: 10.1016/j.eururo.2011.01.001. Epub 2011 Feb 18.
The European Randomised Study of Screening for Prostate Cancer (ERSPC) applies a prostate-specific antigen (PSA) cut-off value ≥3.0 ng/ml as an indication for lateralised sextant biopsy.
To analyse the incidence and disease-specific mortality for prostate cancer (PCa) in men with an initial PSA <3.0 ng/ml.
DESIGN, SETTING AND PARTICIPANTS: From November 1993 to December 1999, a total of 42,376 men identified from population registries in the Rotterdam region (55-74 yr of age) were randomised to an intervention or control arm. A total of 19,950 men were screened during the first screening round.
A PSA <3.0 ng/ml was below the biopsy threshold. PCa cases were identified at rescreens every 4 yr or as interval cancers.
Distribution of incidence, aggressiveness, and disease-specific mortality of PCa per PSA range was measured. Causes of death were evaluated by an independent committee, and follow-up was complete until 31 December 2008.
From 1993 to 2008, 915 PCa cases were diagnosed in 15,758 men (5.8%) with an initial PSA <3.0 ng/ml and a median age of 62.3 yr. Median overall follow-up was 11 yr. PCa incidence increased significantly with higher initial PSA levels. Aggressive PCa (clinical stage ≥T2c, Gleason score ≥8, PSA >20 ng/ml, positive lymph nodes, or metastases at diagnosis) was detected in 66 of 733 screen-detected PCa cases (9.0%) and 72 of 182 interval-detected PCa cases (39.6%). Twenty-three PCa deaths occurred in the total population (0.15%), with an increasing risk of PCa mortality in men with higher initial PSA values.
The risk of PCa, aggressive PCa and PCa mortality in a screening population with initial PSA <3.0 ng/ml increases significantly with higher initial PSA levels. These results contribute to the risk stratification and individual management of men in PSA-based screening programmes.
欧洲前列腺癌筛查随机研究(ERSPC)采用前列腺特异性抗原(PSA)截断值≥3.0ng/ml 作为侧向六区活检的指征。
分析初始 PSA<3.0ng/ml 的男性前列腺癌(PCa)的发病率和疾病特异性死亡率。
设计、地点和参与者:1993 年 11 月至 1999 年 12 月,从鹿特丹地区的人口登记册中随机抽取 42376 名年龄在 55-74 岁的男性进入干预组或对照组。共有 19950 名男性在第一轮筛查中接受了筛查。
PSA<3.0ng/ml 低于活检阈值。在每 4 年一次的复查中或作为间期癌发现 PCa 病例。
测量每个 PSA 范围内 PCa 的发病率、侵袭性和疾病特异性死亡率分布。死因由独立委员会评估,随访至 2008 年 12 月 31 日结束。
从 1993 年到 2008 年,在 15758 名初始 PSA<3.0ng/ml 的男性中诊断出 915 例 PCa(5.8%),中位年龄为 62.3 岁。中位总随访时间为 11 年。随着初始 PSA 水平的升高,PCa 的发病率显著增加。在 733 例筛查发现的 PCa 病例中,有 66 例(9.0%)为侵袭性 PCa(临床分期≥T2c、Gleason 评分≥8、PSA>20ng/ml、阳性淋巴结或诊断时转移),在 182 例间期发现的 PCa 病例中,有 72 例(39.6%)为侵袭性 PCa。在总人群中,有 23 例 PCa 死亡(0.15%),随着初始 PSA 值的升高,PCa 死亡的风险也随之增加。
在初始 PSA<3.0ng/ml 的筛查人群中,PCa、侵袭性 PCa 和 PCa 死亡率的风险随着初始 PSA 水平的升高而显著增加。这些结果有助于对 PSA 为基础的筛查项目中男性进行风险分层和个体化管理。