The Impact of Antioxidants on MRI Markers of Cell Proliferation and Hypoxia Among Men on Active Surveillance With Early Stage Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- To determine the impact of combination vitamin E, lycopene, and selenium on MRI detected prostate tumor size and/or tumor blood flow among me on active surveillance
研究概览
简要总结
The purpose of this study is to determine whether antioxidants (vitamin E, selenium and lycopene)can change(reduce)prostate tumor size or blood flow to the prostate as determined by MRI imaging among men on Active Surveillance.
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
- 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
- •MRI detectable prostate cancer
- •PSA less than 15 ng/ml
- •Gleason score <= 7
- •Prostate cancer staging T1c or T2a
排除标准
- •Concurrent use of high-dose vitamins which include selenium, lycopene, vitamin D or vitamin E
- •Other malignancies diagnosed or requiring treatment within the past 5 years (except superficial bladder cancer or basal cell carcinoma)
- •Current use of Proscar or Avodart
研究组 & 干预措施
A
This group of men will be on active treatment (antioxidants) for one year and placebo for the second year.
干预措施: Lycopene, Vitamin D3, Selenium, Green Tea Extract, Vitamin E (Dietary Supplement)
A
This group of men will be on active treatment (antioxidants) for one year and placebo for the second year.
干预措施: Placebo (Drug)
B
This group of men will be on placebo for one year and active treatment (antioxidants) for the second year.
干预措施: Lycopene, Vitamin D3, Selenium, Green Tea Extract, Vitamin E (Dietary Supplement)
B
This group of men will be on placebo for one year and active treatment (antioxidants) for the second year.
干预措施: Placebo (Drug)
结局指标
主要结局
To determine the impact of combination vitamin E, lycopene, and selenium on MRI detected prostate tumor size and/or tumor blood flow among me on active surveillance
时间窗: At baseline MRI compared to 1-year MRI compared to 2-year MRI
次要结局
未报告次要终点