PHASE II CHEMOPREVENTION TRIAL OF SE AND PROSTATE CANCER

这项试验的主要目的是评估 必需的微量元素硒(Se)可抑制糖尿病的进展 前列腺癌。这项试验的理由是基于结果 在营养预防癌症(NPC)试验中，我们的双盲 一项随机试验，观察到前列腺减少了63% 癌症发病率发生在#年的最初10年随访期间 接受200杯硒的患者与安慰剂组1进行比较。 这项试验将患者随机分为安慰剂和两种药物中的一种。 剂量，200和800µg/d。主要终点是速度 前列腺癌进展的主要血清标记物，前列腺癌- 特异性抗原(PSA)。额外的终点是疾病发生的时间 进展、激素治疗的开始和记录的时间 转移性疾病。试验的安全终点包括 早期轻微的硒中毒症状以及 肝脏和肾脏的酶水平。这项试验将随机抽取至少220人 患者，为了有80%的能力来检测50%的 PSA速度减慢，阿尔法为0.05，平均 45个月的随访期。50%的治疗效果为 之所以选择它，是因为它的治疗效果是在NPC中观察到的一半 在治疗滞后2年后进行试验(RR=0.25)。

The principal purpose of this trial is to assess the potential for the essential trace element selenium (Se) to inhibit the progression of prostate cancer. The rationale for this trial is based on the results of the Nutritional Prevention of Cancer (NPC) Trial, our double blind randomized trial which observed a 63 percent reduction in prostate cancer incidence occurred during the initial 10 years of follow up in the patients receiving 200 mug of Se compared io the placebo group 1. The trial will randomize patients to either placebo or one of two Se dosages, 200 mug, and 800 mug/d. The primary endpoints is the velocity of the primary serum marker of prostate cancer progression, prostate- specific antigen (PSA). Additional endpoints are time to disease progression, initiation of hormone therapy and time to documented metastatic disease. 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 220 patients, in order to have 80 percent power to detect a 50 percent decrease in the velocity of PSA with an alpha of 0.05, during an average of 45 months of follow up. The treatment effect of 50 percent was selected because it is half the treatment effect observed in the NPC trial after a 2 year treatment lag (RR=0.25).