DESIGN OF THE PROSTATE-CANCER PREVENTION TRIAL (PCPT)

被引：112

作者：

FEIGL, P

BLUMENSTEIN, B

THOMPSON, I

CROWLEY, J

WOLF, M

KRAMER, BS

COLTMAN, CA

BRAWLEY, OW

FORD, LG

机构：

[1] BROOKE ARMY MED CTR,DEPT SURG,UROL SERV,FT SAM HOUSTON,TX 78234

[2] NATL CANC INST,DIV CANC PREVENT & CONTROL,BETHESDA,MD

[3] SW ONCOL GRP,OPERAT OFF,SAN ANTONIO,TX

[4] SAN ANTONIO CANC INST,SAN ANTONIO,TX

来源：

CONTROLLED CLINICAL TRIALS | 1995年 / 16卷 / 03期

关键词：

CHEMOPREVENTION; PROSTATE CANCER; MONITORING TECHNIQUES; BIASED ASCERTAINMENT;

D O I：

10.1016/0197-2456(94)00XXX-M

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

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.

引用

页码：150 / 163

页数：14

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