Pilot Study to Describe Changes in Urinary and Gut Microbiome During Androgen Deprivation and Radiation Therapy for Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Feasibility of detecting and categorizing urinary and gut microbiota
研究概览
简要总结
This study collects urine and stool samples to determine the ability to identify changes in the microbiome (bacteria, fungi, and viruses that live in the gut and urine) of patients with prostate cancer during androgen deprivation therapy and radiation therapy. Radiation therapy has the potential to harm the genitourinary area or the bowel, causing a feeling of urgency or increased inflammation in the area. The radiation therapy is designed to not irradiate the bowel and bladder areas, but there is still some radiation exposure. The gut microbiome has been associated with differences in inflammation as well as producing molecules that influence healing. The purpose of this study is to see whether the microbiome may contribute to the healing of the organs exposed to radiation. Information learned from this study may help researchers discover a new risk factor that could be manipulated to improve the quality of life in patients with prostate cancer.
详细描述
PRIMARY OBJECTIVE:
I. To determine the feasibility of identifying changes in urine and gut microbiomes during androgen deprivation therapy and radiation therapy for prostate cancer.
SECONDARY OBJECTIVE:
I. To explore associations between baseline microbiomes and urinary or gastrointestinal radiation toxicity by Common Terminology Criteria for Adverse Events (CTCAE) and Patient Reported Outcomes (PRO).
OUTLINE:
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
- •Pathologically confirmed prostate cancer, with a plan to receive radiation therapy for either definitive (cohort A) or salvage (cohort B) therapy. Patients without planned androgen deprivation therapy (ADT) will be accrued to cohort C
- •Cohort A will be restricted to Gleason grade group 3 or higher (4+3 or 8-10) so that androgen deprivation will be indicated
- •Cohort B will not be restricted by Gleason grade but will require rising prostate-specific antigen (PSA) and a plan for ADT with salvage radiation
- •Cohort C will be prostate cancer patients in whom definitive or salvage radiation is planned without ADT
- •Patients must be age 18 or older
- •Willing to provide urine and stool samples at specified time points
排除标准
- •Men with inflammatory bowel disease or pre-existing cystitis will be excluded
结局指标
主要结局
Feasibility of detecting and categorizing urinary and gut microbiota
时间窗: Up to 3 years
Will be defined as the ability to generate a microbial profile for \>= 80% of samples.
次要结局
- Detectability of changes(Up to 3 years)
- Detectability of associations between microbial populations and toxicity(Up to 3 years)