前列腺癌预防试验：现状
The Prostate Cancer Prevention Trial: current status.
作者信息
Higgins Betsy, Thompson Ian M
机构信息
Divison of Urology, University of Texas Health Science Center at San Antonio, Texas 78229, USA.
出版信息
J Urol. 2004 Feb;171(2 Pt 2):S15-7; discussion S8. doi: 10.1097/01.ju.0000107440.15626.11.
PURPOSE
The rationale, design considerations and current status of the Prostate Cancer Prevention Trial (PCPT) are presented.
MATERIALS AND METHODS
The design considerations for a prevention study involving finasteride were reviewed. Most notable was the end of study biopsy planned for all participants to eliminate any detection bias caused by the effect of finasteride on prostate specific antigen.
RESULTS
During a 3-year period 18,882 men were randomized in the PCPT. The final end of study biopsy is planned for May 2004. The study was closed 15 months before the final anticipated participant biopsy by the independent Data and Safety Monitoring Committee due to a 24.8% reduction in prostate cancer with finasteride.
CONCLUSIONS
The extraordinary accrual of PCPT of healthy men in a prospective study to test an intervention for prostate cancer prevention illustrates the potential for future studies. The positive results of the trial as well as many observations that have been made of the study population argue for increased emphasis on prevention research for highly prevalent genitourinary malignancies.
目的
介绍前列腺癌预防试验（PCPT）的基本原理、设计考量及当前状况。
材料与方法
回顾了一项涉及非那雄胺的预防研究的设计考量。最值得注意的是计划对所有参与者进行研究结束时的活检，以消除非那雄胺对前列腺特异性抗原的影响所导致的任何检测偏差。
结果
在3年期间，18882名男性被随机纳入PCPT。计划于2004年5月进行最终的研究结束时活检。由于使用非那雄胺使前列腺癌减少了24.8%，独立的数据与安全监测委员会在预计的最后一名参与者活检前15个月终止了该研究。
结论
PCPT在一项前瞻性研究中对健康男性进行了非凡的招募，以测试一种前列腺癌预防干预措施，这说明了未来研究的潜力。该试验的阳性结果以及对研究人群的许多观察结果表明，应更加重视对高度常见的泌尿生殖系统恶性肿瘤的预防研究。
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