Molecular Mechanisms of Dutasteride and Dietary Interventions to Prevent Prostate Cancer and Reduce Its Progression
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Effects of the Interventions on Lipid Metabolism From Blood and Prostatic Microenvironment
研究概览
简要总结
The purpose of this study is to determine whether marine omega-3 fatty acids and 5-alpha-reductase inhibitor are effective in the progression of prostate cancer for low-risk prostate cancer patients.
详细描述
The study has a duration of 1 year for each participant. Subjects will be first assigned to a dietary or a dutasteride intervention that they will consume for the first 6 months. After 6 months, all men will have a combined intervention of dutasteride and diet to complete follow-up of 12 months. This will allow us to study interactive effects.
Dietary intervention consists on a high w-3 long-chain fatty acids diet without supplement and to reduce intake of saturated and trans fatty acids.
Prostatic biopsies will be taken at time of diagnosis and at 6 and 12 months after the beginning of the study. Blood will be drawn before each prostate biopsy session and urine will be collected before each prostate biopsy and after digital rectal examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Low-risk prostatic neoplasms
- •Candidate for active surveillance
- •Informed consent
排除标准
- •Current fish oil supplementation
- •Current NSAID use
研究组 & 干预措施
Dietary intervention first
The dietary intervention will be aimed to increase intake of ω-3 long chain fatty acids and to reduce intake of saturated and trans fatty acids.
干预措施: Dietary intervention first (Other)
Drug intervention first
Intake of 5α-Reductase Inhibitor
干预措施: Drug (Dutasteride) intervention first (Drug)
结局指标
主要结局
Effects of the Interventions on Lipid Metabolism From Blood and Prostatic Microenvironment
时间窗: 0-6-12 months
In this aim the investigators will measure the effects of the interventions on the fatty acid profile of phospholipids from RBC and from snap frozen prostate tissue. Fatty acid profile from prostatic tissue has never been studied. The investigators aim that change in fatty acid intake will affect fatty acid profile of prostatic tissue. Fatty acid profile from red blood cells will serve as a marker of dietary fatty acid intake. Previous studies have shown that fatty acids profile from RBC differs from the one from muscle tissue and that the dietary effect on RBC fatty acids profile is almost maximal within 6 months.
次要结局
- Effect of Interventions on Gene Expression Profile(0-6-12 months)
- Effects of Interventions on Hormonal Metabolism(0-6-12 months)
- Determine the Clinical Utility of Urine-Based Cancer Markers in the Context of Interventions to Reduce Cancer Progression(0-6-12 months)