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: 7377769
• 负责人: E DAVID CRAWFORD
• 金额: $ 45.92万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7377769
• 关键词: SELENIUM; VITAMIN; CANCER; PREVENTION; TRIAL

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.

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。针对乳腺癌和前列腺癌的明确预防试验分别于1993年在乳腺癌预防试验（breast cancer prevention Trial， BCPT）和前列腺癌预防试验（prostate cancer prevention Trial， PCPT）中同时产生。西南肿瘤小组（SWOG）于2000年7月启动了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年的报告强调了预防前列腺癌的问题，特别指出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指征。根据西南肿瘤组织（Southwest Oncology Group）的研究，关于硒和维生素E在预防前列腺癌方面的潜在作用，最有力的证据来自两项随机、安慰剂对照的临床试验的次要发现。这两种补充剂的发展已经到了需要随机、安慰剂对照干预的阶段，以检验关于这两种补充剂的前列腺癌化学预防作用的主要假设。在过去十年中，前列腺癌一直是美国男性中最常见的恶性肿瘤（不包括非黑色素瘤皮肤癌）。白种人男性患前列腺癌的估计终生风险为16.6%，非裔美国男性为18.1%。白种人死于前列腺癌的终生风险为3.5%，非裔美国人为4.3%。SELECT试验雄心勃勃的招募目标是32400人，并建议对男性进行长达12年的跟踪调查。非裔美国男性的参与率有望达到20%。由于非洲裔美国人发病较早，因此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，但次要目标是评估硒和维生素E对其他癌症（包括肺癌、结直肠癌和所有癌症）发病率的影响。由于快速累积，本研究将于2004年6月下旬结束招募，此后，随访和依从性监测将至关重要。关于肺功能和结直肠癌早期检测的配套研究已经提出，并可能利用GCRC。