DESIGN OF THE PROSTATE-CANCER PREVENTION TRIAL (PCPT)
DESIGN OF THE PROSTATE-CANCER PREVENTION TRIAL (PCPT)
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DOI：
10.1016/0197-2456(94)00xxx-m
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发表时间：
1995-06-01
期刊：
影响因子：
--
通讯作者：
FORD, LG
中科院分区：
文献类型：
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作者：
FEIGL, P;BLUMENSTEIN, B;FORD, LG
PCPT 是一项非那雄胺的化学预防试验，主要终点是活检证明是否存在前列腺癌。总共 18,000 名 55 岁及以上的健康男性将被随机分组。一半将接受非那雄胺（5 毫克/天），一半将接受安慰剂（每天一粒匹配药片），持续 7 年。该试验的设计目的是使用 alpha = 0.05 的双边测试，以 92% 的功效检测到经活检证实的疾病的期间患病率降低 25%。由于非那雄胺对前列腺癌的主要筛查测试前列腺特异性抗原（PSA）的已知影响，该试验变得复杂。本文描述了 PCPT 设计并参考了所考虑的替代方案。所选择的设计取决于五个关键假设，在整个 9 年的试验中必须密切监控这些假设。
The PCPT is a chemoprevention trial of finasteride with a primary endpoint of biopsy-proven presence or absence of prostate cancer. A total of 18,000 healthy men, aged 55 years and older, will be randomized. Half will receive finasteride (5 mg/day) and half will receive placebo (one matching tablet per day) for 7 years. The trial is designed to have 92% power to detect a 25% reduction in period prevalence of biopsy-proven disease using a two-sided test with alpha = 0.05. The trial is complicated by the known impact of finasteride on the major screening test for prostate cancer, prostate specific antigen (PSA). This paper describes the PCPT design with reference to alternatives that were considered. The chosen design depends on five critical assumptions that must be monitored closely throughout the 9-year trial.