Role of Soy Isoflavones in Prostate Cancer Prevention
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Effect of Soy Isoflavones on Serum Testosterone Levels.
研究概览
简要总结
This is a randomized study evaluating the effectiveness and direct effect a commercial soy supplement has on prostate cancer and normal prostate tissue. Patient will be randomized it either receive placebo or a commercial soy supplement for 2-4 weeks prior to the planned surgery for treatment of their prostate cancer. Patient's blood and prostate tissue will be evaluated to determine the effects of the soy supplement on the prostate tissue.
详细描述
This is a randomized study evaluating the effectiveness and direct effect a commercial soy supplement has on prostate cancer and normal prostate tissue. Patients will be randomized to either receive placebo or a commercial soy supplement for 2-4 weeks prior to the planned surgery for treatment of their prostate cancer. The specific objectives are:
- To assess the effect of soy supplementation on endogenous hormone production levels and serum prostate specific antigens.
- To assess the impact of soy supplementation on estrogen receptor expression(ER).
- To determine the impact of soy isoflavones on cell cycle regulation and associated gene expression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically proven prostate cancer.
- •Surgical candidate for prostatectomy.
- •During study period, must agree not to take new supplements.
- •No concurrent chemotherapy, radiation or hormonal therapy.
- •No history of prior allergy to soy based products.
- •Must not have been taking soy supplements or soy isoflavones within 90 days prior to study enrollment.
- •Must be able to safely be on study supplements for period of at least two weeks prior to scheduled prostatectomy.
- •Must give written and informed consent in accordance with institutional and federal guidelines.
排除标准
- •During study period, must agree not to take new supplements.
- •No concurrent chemotherapy, radiation or hormonal therapy.
- •No history of prior allergy to soy based products.
- •Must not have been taking soy supplements or soy isoflavones within 90 days prior to study enrollment.
- •Must be able to safely be on study supplements for period of at least two weeks prior to scheduled
研究组 & 干预措施
Arm Placebo
Placebo
干预措施: Placebo (Drug)
Arm Soy Supplement
Soy Supplement
干预措施: Soy Supplement (Drug)
结局指标
主要结局
Effect of Soy Isoflavones on Serum Testosterone Levels.
时间窗: Two weeks
Total testosterone (ng/ml) serum levels were measured at the time of enrollment(baseline), after two weeks on soy supplement(time point 1), and just prior to prostatectomy (time point 2). All patients must have completed at least two week of soy supplement or placebo and time point 3 varied depending on date of planned prostatectomy. Results were analyzed and are reported at the two week time period, comparing between patients receiving soy supplement or placebo.
次要结局
- Effect of Soy Isoflavones on Estrogen Receptor Status(Two weeks)
- Molecular Effects of Soy Supplementation Compared to Placebo.(One year)