NCT00269555已完成不适用
Effects of a Genistein Combined Polysaccharide (GCP) on Patients With a Diagnosis of Prostate Cancer on Active Surveillance.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Reduction in PSA serum levels.
研究概览
简要总结
Genistein Combined Polysaccharide (GCP) is derived from adding soy powder to shiitake mushrooms. This concentrated mixture is currently being sold in Japan and the United States and is thought to possibly contain properties that may be useful in treating certain types of cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Participants must be male and have a pathological diagnosis of prostate cancer.
- •No treatment (surgery [RRP], radiation, or hormones) prior to study entry.
- •The patient has decided, after consultation with his own doctor, to have no treatment intervention (surgery [RRP], radiation, or hormones) for the next six months.
- •PSA between 2.0 and 10.0 ng/ml.
- •If PSA is >10.0, patient must have been on Active Surveillance for 12 months prior to study initiation.
- •No known allergy to soy or soy products.
- •The patient is not currently taking more than 2 grams of genistein a day in nutritional or diet enhancing supplements (OTC supplements).
排除标准
- •No pathological documentation of prostate cancer.
- •Allergy to soy or soy products
- •Prior history of treatment for prostate cancer.
结局指标
主要结局
Reduction in PSA serum levels.
次要结局
- Stabilization of PSA serum levels.
研究者
研究点 (2)
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