NCT00584532已完成2 期
Effects of a Genistein Concentrated Polysaccharide (GCP) on Patients With a Diagnosis of Prostate Cancer on Active Surveillance.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 主要终点
- Decrease in PSA levels in men on GCP
研究概览
简要总结
Genistein Combined Polysaccharide (GCP) may play a role as a secondary chemopreventive agent in the treatment of localized prostate 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 (Participant, Investigator)
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
- •Pathological diagnosis of prostate cancer must be confirmed and on file with CRA prior to study entry.
- •No treatment (surgery, radiation, or hormones) prior to study entry.
- •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).
- •Participant has not been on any previous GCP clinical trial.
- •Normal Chemistry values prior to study entry.
排除标准
- •No pathological documentation of prostate cancer.
- •Prior treatment for prostate cancer.
- •PSA >10.0 ng/ml but not on Active Surveillance for 12 months.
- •Allergy to soy or soy products.
- •Abnormal chemistry values.
研究组 & 干预措施
A
Placebo Comparator
A=Placebo ARM of Study
干预措施: Placebo (Drug)
B
Active Comparator
B=GCP Capsules. Ten 500 mg capsules per day for a total of 5 grams a day.
干预措施: GCP - Genistein Combined Polysaccharide (Drug)
结局指标
主要结局
Decrease in PSA levels in men on GCP
时间窗: 6 Months
次要结局
- Increased PSA Doubling Time (PSADT)in men on GCP.(6 Months)
研究者
相似试验
Unknown
2 期
Synthetic Genistein (BONISTEIN™) in Patients Who Are Undergoing Surgery for Prostate CancerProstatic NeoplasmsNCT00546039University Hospital, Aker47
已完成
不适用
Effects of GCP on Prostate Cancer.Prostate CancerNCT00269555University of California, Davis62
已完成
不适用
Carboxypeptidase-G2 in Treating Nervous System Toxic Effects in Patients Given an Overdose of Intrathecal MethotrexateNeurotoxicityUnspecified Adult Solid Tumor, Protocol SpecificUnspecified Childhood Solid Tumor, Protocol SpecificNCT00018967National Cancer Institute (NCI)10
未知
不适用
The effect of a novel polysaccharide blend (PGX® micro-granules) on short- term weight loss and other laboratory parameters in overweight and obese adults: an observational retrospective analysisObesityISRCTN50749194Factors Group of Nutritional Companies Inc. (Canada)29
已完成
早期 1 期
Genistein and Interleukin-2 in Treating Patients With Metastatic Melanoma or Kidney CancerKidney CancerMelanoma (Skin)NCT00276835Northwestern University15