To Investigate the Role of Gut Microbiome in Androgen Deprivation Therapy Related Metabolic Changes in Prostate Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To assess the changes in gut microbiota in prostate cancer patients after initiation of androgen deprivation therapy (ADT)
研究概览
简要总结
Prostate cancer is the second most common cancer in male cancer globally and ranked third in Hong Kong. While androgen deprivation therapy (ADT) is the backbone treatment for advanced prostate cancer, it could lead to obesity, metabolic syndrome and increased cardiovascular mortality. Previous studies showed that ADT patients have different gut microbiome compared to non-ADT patients and the gut microbiome might be related to the metabolic changes. However, the underlying mechanism of these metabolic complications is still not fully understood. This study aims to investigate the relationship and related mechanism between the changes in gut microbiomes and ADT-related metabolic change in prostate cancer patients.
详细描述
It is a prospective longitudinal observational human study. Fifty prostate cancer patients planned for ADT will be recruited. Fecal sample will be collected before initiation of ADT, and then at 3 and 6 months after initiation of ADT. Anthropometric, blood metabolic parameters, serum inflammation markers and panels of microbiome metabolites will be measured at these timepoints. Changes in gut microbiome from baseline to 6 months after initiation of ADT will be assessed. Correlation of changes in gut microbiome and metabolic changes, as well as inflammation and microbiome metabolites, will be assessed and possible mechanisms will be explored.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subject with age 45 or above
- •Histological diagnosis of prostate cancer (acinar type)
- •Clinically decided for androgen deprivation therapy (ADT) as treatment for prostate cancer
排除标准
- •History of diabetes
- •Patients that have other active treatment for prostate cancer or other cancers (except ADT)
- •Patients received treatment, either surgical or medical, that could lead to decrease in serum testosterone prior to commencement of ADT
- •Patients will be started on other treatments, including chemotherapy, new generation of androgen-receptor targeted agents, radiotherapy etc, within 6 months of the commencement of ADT.
- •Subject with recent antibiotics usage within 3 months.
结局指标
主要结局
To assess the changes in gut microbiota in prostate cancer patients after initiation of androgen deprivation therapy (ADT)
时间窗: Baseline, Month 3, Month 6
Gut microbiome related metabolites will be measured by ELISA and mass spectrometry.
次要结局
未报告次要终点
研究者
Chi Fai NG
Professor
Chinese University of Hong Kong