PHASE III TRIAL OF SELENIUM FOR PROSTATE CANCER PREVENT

硒预防前列腺癌的第三期试验

• 批准号: 6666621
• 负责人: Frederick R Ahmann
• 金额: $ 8.73万
• 依托单位: UNIVERSITY OF ARIZONA
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-30 至 2005-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6666621
• 关键词: cancer prevention; clinical research; clinical trial phase III; diet therapy; dietary supplements; dietary trace element; drug administration rate /duration; glutathione peroxidase; human subject; human therapy evaluation; male; neoplasm /cancer epidemiology; neoplastic process; nutrition related tag; oxidoreductase; patient oriented research; prostate neoplasms; prostate specific antigen; selenium; thioredoxin

The principal purpose of this trial is to assess the potential for treatment with the essential trace element selenium (Se) to prevent prostate cancer (PCa). The rationale for this trial is based on the results of the Nutritional Prevention of Cancer Trial, a randomized, double-blind clinical intervention trial. The results of this trial show a 63 percent reduction in PCa incidence during the initial 10 years of follow up in the patients receiving 200 mug/d of Se compared to the placebo group1. The trial will randomize patients to either placebo or one of two Se dosages, 200 mug/d or 400 mug/d The primary endpoints for the trial are the incidence of PCa and the velocity of the primary serum marker of prostate cancer progression, prostate specific antigen (PSA). Safety endpoints for the trial include onset of early mild symptoms of Se toxicity as well as significant changes in liver and kidney enzyme levels. The trial will randomize at least 700 patients with persistently elevated PSA levels (greater than 4 ng/ml) and at least one negative biopsy for prostate cancer. The trial will follow patients for up to 57 months, (an average of 51 months) and have 80 percent power to detect a 50 percent decrease in the incidence of PCa with an alpha of 0.05. The treatment effect of 50 percent was selected because it is one half the treatment effect observed in the NPC trial after a two year treatment lag (RR=0.25). In addition to PCa incidence, prostate biopsies and surgical tissue will be analyzed to explore both biomarkers of prostate cancer progression and possible mechanisms by which Se supplementation affects PCa.

本试验的主要目的是评估必需微量元素硒（Se）预防前列腺癌（PCa）的治疗潜力。这项试验的基本原理是基于营养预防癌症试验的结果，这是一项随机、双盲的临床干预试验。这项试验的结果显示，在最初10年的随访中，与安慰剂组相比，每天服用200杯硒的患者PCa发病率降低了63%。该试验将随机分配患者使用安慰剂或两种硒剂量（200杯/天或400杯/天）中的一种。试验的主要终点是前列腺癌的发病率和前列腺癌进展的主要血清标志物前列腺特异性抗原（PSA）的速度。该试验的安全终点包括早期轻度硒中毒症状的出现以及肝脏和肾脏酶水平的显著变化。该试验将随机抽取至少700名PSA水平持续升高（大于4 ng/ml）且至少一次前列腺癌活检阴性的患者。该试验将对患者进行长达57个月的随访（平均为51个月），并且有80%的能力检测到PCa发病率降低50%，alpha值为0.05。选择50%的治疗效果是因为它是两年治疗滞后后在鼻咽癌试验中观察到的治疗效果的一半（RR=0.25）。除前列腺癌发病率外，还将分析前列腺活检和手术组织，以探索前列腺癌进展的生物标志物和硒补充影响前列腺癌的可能机制。