Prostate Metabolism, Cancer Risk and Gut Microbiota
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Gut microbiota signature
研究概览
简要总结
This is a prospective, single center translational multiple cohort study to investigate the association of gut microbiota and prostate cancer.
详细描述
Prostate cancer (PCa) is a significant health care system challenge. PCa is the most common male cancer in Finland and most western countries. Interestingly, although the incidence of indolent (latent) PCa is very similar throughout the globe, there is a remarkable global age-adjusted incidence variation (up to 40-fold difference between highest and lowest incidences).
Epidemiological data suggest that aging in men is associated with neoplastic processes in the prostate but only a subset of men will develop a true malignancy potentially affecting their life-span or quality of life. Genetic factors have a significant effect on PCa risk, but very likely life-style (e.g. diet and physical activity) affect PCa risk as well, but the mechanisms mediating protective or harmful effects of life-style remain unclear.
Gut microbiota, i.e. the collection of microbes colonizing the gastrointestinal tract, has been acknowledged to play significant role in many metabolic pathways and pathogenetic processes in the human body. Although there is some evidence suggesting that gut microbiota affects therapy responses (especially androgen deprivation) in PCa, it´s potential role in prostate carcinogenesis is not well documented. Our previous studies suggest that gut microbiota composition is different in men with and without PCa potentially contributing to the Pca risk, and that changes in steroid hormone synthesis may be one mechanism how gut microbiota affects PCa risk.
PROMIC is a prospective, single center translational multiple cohort study to investigate the association of gut microbiota and PCa. The main aim is to validate our preliminary findings of association between gut microbiota and PCa. We also study metabolic characteristics in the gut, systemic circulation, and prostate tissue in men with different gut microbiota signatures. The study is carried out in Turku University Hospital and University of Turku.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Provision of signed and dated informed consent form.
- •Ability and stated willingness to comply with all study procedures and availability for the duration of the study.
排除标准
- •inability to comply with study procedures or unwillingness to participate in the study.
结局指标
主要结局
Gut microbiota signature
时间窗: immediately before prostate biopsy
Gut microbiota signature in men with clinically significant prostate cancer, clinically non-significant prostate cancer, and benign prostate histology
次要结局
- Gut metabolomics(immediately before prostate biopsy)
