ADJUVANT TRIAL WITH SOY AFTER RADICAL PROSTATECTOMY

该项目的目标是完成正在进行的两个ARM(n=126/ARM)随机、双盲、 安慰剂对照的I/I11期临床试验，用于前列腺癌术后复发的高危男性 根治性前列腺切除术，给予大豆分离蛋白或酪蛋白安慰剂，最多两次 好几年了。剂量为20g蛋白质/天(-22-26毫克/天金雀异黄素和-38-42毫克/天总异黄酮)。 初步结果表明，这种治疗是极其安全的。血清PSA是用一种超强的 每隔两年进行一次灵敏检测(可比常规检测提早一年检测PSA失败) 第一年每个月，第二年每三个月。我们将总共招收284名男子(假设13%的人辍学 基于初步结果)来自美国各地至少八个临床站点，其中两个也有 退伍军人医疗中心的子网站。比较治疗组和安慰剂组，主要终点是 前列腺癌复发的PSA失败率。基于文献数据和 已经登记的男性的特征，我们预计在这一组中，两年内PSA失败率为30% 必须满足以下至少一项资格标准的男性：术前PSA和GT；20 ng/ml，格里森 7、手术切缘阳性、包膜外侵犯、精囊侵犯和/或淋巴转移 (微)转移。126个/ARM的样本量将使我们检测到PSA比率下降40% 功率为80%的情况下，故障从30%下降到18%，显著水平为0.05。我们还将确定是否 大豆干预会影响PSA失败的时间、血清胆固醇和血清异黄酮水平。此外, 将确定对睾酮、雌二醇和SHBG(类固醇激素轴)以及T3和T4的影响 (甲状腺活动)。这项研究将提供有关含有异黄酮类大豆蛋白预防 前列腺癌根治术后的复发。该研究还将提供关于以下方面的信息 大豆蛋白在未被诊断为前列腺癌的男性中的预防潜力，因为 在这些未被发现的组织学前列腺癌患者中有很高的患病率(50%)。

The objective of this project is to complete an ongoing two arm (n = 126/arm) randomized, double-blind, placebo-controlled phase I I/I11 clinical trial in men who are at high risk for prostate cancer recurrence after a radical prostatectomy with administration of soy protein isolate or a casein-based placebo for up to two years. The dose is 20 g protein/day (-22-26 mg/day genistein and -38-42 mg/day total isoflavones). Preliminary results indicate that this treatment is extremely safe Serum PSA is being measured with an ultra- sensitive assay (which allows detection of PSA failure one year earlier than conventional assays) every 2 months in year 1 and every 3 months in year 2. We will accrue a total of 284 men (assuming a 13% drop-out rate based on preliminary results) from at least eight clinical sites around the USA, two of which also have a sub-site at a VA Medical Center. Comparing the treatment and placebo groups, the primary end-point is the rate of PSA failure as surrogate for prostate cancer recurrence. Based on literature data and the characteristics of already enrolled men, we expect a 30% rate of PSA failure in two years in this group of men who must fulfill at least one of the following eligibility criteria: pre-operative PSA >20 ng/ml, Gleason sum of > 7, positive surgical margins, extracapsular extension, seminal vesicle invasion, and/or lymph node (micro) metastases. The sample size of 126/arm will allow us to detect a 40% reduction in the rate of PSA failure from 30% to 18% with 80% power at a significance level of 0.05. We will also determine whether the soy intervention affects time-to-PSA failure, serum cholesterol, and serum isoflavone levels. In addition, effects will be determined on testosterone, estradiol, and SHBG (steroid hormone axis), and T3 and T4 (thyroid activity). This study will yield information about ability of soy protein containing isoflavonesto prevent recurrence of prostate cancer after radical prostatectomy. The study will also provide information about of the preventive potential of soy protein in men that have not been diagnosed with prostate cancer, because there is a high prevalence (>50%) in these men of undetected histologic prostate carcinomas.