ADJUVANT TRIAL WITH SOY AFTER RADICAL PROSTATECTOMY

根治性前列腺切除术后大豆辅助试验

• 批准号: 7093292
• 负责人: MAARTEN C BOSLAND
• 金额: $ 12.55万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-08-11 至 2006-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7093292
• 关键词: clinical research; neoplasm /cancer; neoplasm /cancer relapse /recurrence; prostate neoplasms; proteins; serum; success; clinical research; neoplasm /cancer; neoplasm /cancer relapse /recurrence; prostate neoplasms; proteins; serum; success

DESCRIPTION (provided by applicant): The objective of this project is to complete an ongoing two arm (n = 126/arm) randomized, double-blind, placebo-controlled phase I I/III 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 (approximately 22-26 mg/day genistein and approximately 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 isoflavones to prevent recurrence of prostate cancer after radical prostatectomy. The study will also provide information about the preventive potential of soy protein in men that have not been diagnosed with prostate cancer, because there is a high prevalence (greater than or equal to 50%) in these men of undetected histologic prostate carcinomas.

描述（由申请人提供）：该项目的目的是完成一个持续的两臂（n = 126/ARM）随机，双盲，安慰剂对照的I/III期I/III期临床试验，这些男性具有前列腺癌复发高风险的男性，其基于大豆蛋白蛋白隔离或基于casin的地理位置，以供前列腺癌复发，以适用于两年。剂量为20 g蛋白/天（约22-26 mg/天染料木黄酮和约38-42 mg/天总的异黄酮）。初步结果表明，这种治疗非常安全。 通过超敏感测定法进行血清PSA（允许比常规测定早一年，比常规测定早一年）和2年级的每3个月每2个月都要测量。我们将总共284名男性（假设基于初步结果的辍学率）至少在美国附近的​​八个临床部位，这两个也是一个医疗中心。比较治疗和安慰剂组，主要终点是PSA失败的率作为前列腺癌复发的替代。根据文献数据和已经注册的男性的特征，我们预计这组男性两年内的PSA失败率为30％，他们必须符合以下至少一个以下资格标准：术前PSA> 20 ng/ml，GLESAN> 20> 7，> 7，正手术余量，阳性延伸，囊外延伸，弹性vessicle vessicle segsy set set necter（或ic）。 126/臂的样本量将使我们能够检测到40％的PSA失败率从30％降低至18％，而功率为80％，显着性水平为0.05。我们还将确定大豆干预是否会影响PSA衰竭，血清胆固醇和血清异黄酮水平。另外，将确定效应对睾丸激素，雌二醇和SHBG（类固醇激素轴）以及T3和T4（甲状腺活性）。这项研究将产生有关含有大豆蛋白质蛋白质蛋白质的能力的信息。该研究还将提供有关未被诊断为前列腺癌的男性预防潜力的信息，因为这些未发现的组织学前列腺癌的男性患病率很高（大于或等于50％）。