S0000, SELENIUM AND VITAMIN E CANCER PREVENTION TRIAL (SELECT)

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 在硒和维生素E中，它们在预防前列腺癌方面潜在作用的最有力证据来自两个随机、安慰剂对照临床试验的二次发现。这两种补充剂的开发已经到了需要随机、安慰剂对照干预的阶段，以检验关于这些补充剂的前列腺癌化学预防效果的主要假设。数据表明，硒和维生素E的活性是互补的，这两种补充剂在抑制癌症发生方面具有协同作用。这一证据使得同时测试这两种补充剂的2 x 2析因设计成为验证性第三阶段试验的一个特别有吸引力的选择。我们假设维生素E和/或硒补充剂可以预防或减少前列腺癌。目的是评估单独和联合使用硒和维生素E对前列腺癌临床发病率的影响。学习期限为十二年，五年统一累计期，至少七年治疗。参与者将接受研究药物治疗，直到一个共同的时间点(整个试验的长度在7到12年之间，取决于参与者被随机分配的时间)。这项研究将有助于评估这种干预措施对前列腺癌的治疗效果。 我

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. In both selenium and vitamin E, the strongest evidence for their potential roles in preventing prostate cancer comes from secondary findings of two randomized, placebo-controlled clinical trials. The development of these two supplements has arrived at the stage where a randomized, placebo-controlled intervention is needed to test the primary hypothesis regarding these supplements' prostate cancer chemoprevention effects. Data indicate that activities of selenium and vitamin E are complementary and that the two supplements act synergistically to inhibit carcinogenesis. This evidence makes the 2 x 2 factorial design for simultaneously testing both supplements a particularly attractive option for the confirmatory Phase III trial. We hypothesize that Vit E &/or Selenium Supplements would prevent or decrease Prostate Cancer. The aims are to assess the effect of selenium and vitamin E alone and in combination on the clinical incidence of prostate cancer. Study duration will be twelve years, with a five-year uniform accrual period and a minimum of seven years of treatment. Participants will receive study medication until a common point in time (the entire length of the trial is between seven and twelve years depending on when the participant was randomized. The study will help evaluate the therapeutic efficacy of this intervention on prostate cancer I