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

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 在硒和维生素E中，它们在预防前列腺癌方面的潜在作用的最有力证据来自两项随机安慰剂对照临床试验的次要结果。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，以测试关于这些补充剂的前列腺癌化学预防作用的主要假设。数据表明，硒和维生素E的活性是互补的，这两种补充剂协同作用，以抑制致癌作用。这一证据使得同时测试两种补充剂的2 x 2析因设计成为确证性III期试验的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。目的是评估硒和维生素E单独和联合对前列腺癌临床发病率的影响。研究持续时间为12年，其中统一的累积期为5年，治疗期至少为7年。受试者将接受研究药物治疗，直到一个共同的时间点（整个试验的持续时间为7 - 12年，取决于受试者的随机化时间。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