SELENIUM AND VITAMIN E CANCER PREVENTION TRIAL (SELECT) FOR PROSTATE CANCER

硒和维生素 E 预防前列腺癌的癌症试验（选择）

• 批准号: 7604374
• 负责人: E DAVID CRAWFORD
• 金额: $ 41.61万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-07-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604374
• 关键词: Adherence; African American; Age; Breast Cancer Prevention Trial; Cancer Prevention Trial; Caucasians; Caucasoid Race; Chemoprevention; Colorectal; Companions; Computer Retrieval of Information on Scientific Projects Database; Controlled Clinical Trials; Development; Disease; Eligibility Determination; Funding; Goals; Grant; Incidence; Institution; Intervention; Lung; Malignant Neoplasms; Malignant neoplasm of prostate; Micronutrients; Monitor; Placebo Control; Population; Prevention; Prostate Cancer Prevention Trial; Prostate Cancer Progress Review Group; Randomized; Rate; Reporting; Research; Research Personnel; Resources; Respiratory physiology; Role; Selenium; Selenium/vitamin E; Skin Carcinoma; Source; Southwest Oncology Group; Specific qualifier value; Staging; Testing; United States National Institutes of Health; Vitamins; colorectal cancer screening; early onset; follow-up; lifetime risk; male; malignant breast neoplasm; men; prevent; prostate cancer prevention

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. Definitive prevention trials aimed at breast cancer and prostate cancer were spawned simultaneously in 1993 in the Breast Cancer Prevention Trial (BCPT) and Prostate Cancer Prevention trial (PCPT), respectively. The Southwest Oncology Group (SWOG) launched the offspring of the PCPT in July of 2000 in the form of the Selenium and Vitamin E Prostate Cancer Prevention trials (SELECT). The 1998 report of Prostate Cancer Progress Review Group (PRG) highlighted the issue of prostate cancer prevention, specifically citing the promising epidemiological indication for the use of micronutrients selenium and vitamin E in this setting. According to the Southwest Oncology Group, in reference to 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. Prostate cancer has been the most common malignant tumor (excluding non-melanoma skin cancer) in U.S. men for the last decade. The estimate lifetime risk of developing prostate cancer is 16.6% for Caucasian males and 18.1% for African-American males. The lifetime risk of dying from prostate cancer is 3.5% for Caucasian and 4.3% for African Americans. The SELECT trial had an ambitious recruitment goal of 32,400 and proposes to follow men for up to 12 years. It is hoped that a twenty- percent participation rate among African American males will be attained. A lower age eligibility criterion is the specified for African Americans due to the incidence of an earlier onset of the disease in this ethnic population. While prostate cancer is the primary focus of this trial, secondary objectives will assess the effect of selenium and vitamin E on the incidence of other cancers including lung, colorectal and all cancers combined. Due to rapid accrual this study will close to recruitment late June 2004 after which, follow up and adherence monitoring will become paramount. Companion studies regarding lung function and early detection of colorectal cancer have been proposed and may utilize the GCRC.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 针对乳腺癌和前列腺癌的彻底预防试验于1993年同时产生，分别是乳腺癌预防试验（BCPT）和前列腺癌预防试验（PCPT）。西南肿瘤学小组 (SWOG) 于 2000 年 7 月推出了 PCPT 的后代，即硒和维生素 E 前列腺癌预防试验 (SELECT)。前列腺癌进展审查小组 (PRG) 1998 年的报告强调了前列腺癌预防问题，特别引用了在这种情况下使用微量营养素硒和维生素 E 的有希望的流行病学适应症。据西南肿瘤学小组称，关于硒和维生素 E，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发现。这两种补充剂的开发已经达到了需要随机、安慰剂对照干预来测试有关这些补充剂的前列腺癌化学预防作用的主要假设的阶段。过去十年来，前列腺癌一直是美国男性最常见的恶性肿瘤（不包括非黑色素瘤皮肤癌）。白种人男性终生患前列腺癌的估计风险为 16.6%，非裔美国男性为 18.1%。白种人终生死于前列腺癌的风险为 3.5%，非洲裔美国人为 4.3%。 SELECT 试验的雄心勃勃的招募目标是 32,400 人，并计划对男性进行长达 12 年的跟踪。希望非洲裔美国男性的参与率能够达到百分之二十。由于非裔美国人的疾病发病较早，因此对非裔美国人规定了较低的年龄资格标准。虽然前列腺癌是该试验的主要焦点，但次要目标将评估硒和维生素 E 对其他癌症（包括肺癌、结直肠癌和所有癌症的综合）发病率的影响。由于进展迅速，这项研究将于 2004 年 6 月下旬结束招募，此后，随访和依从性监测将变得至关重要。已经提出了关于肺功能和结直肠癌早期检测的伴随研究，并且可以利用 GCRC。