CSP #719B - Prospective Cohort of Early Stage Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,116
- 试验地点
- 13
- 主要终点
- The primary endpoint of the study will be prostate cancer mortality.
研究概览
简要总结
Environmental factors such as diet and cigarette smoking may play a role in predicting the progression of early stage prostate cancer to advance disease. The goal of this project is to establish an observational cohort of patients with early stage prostate cancer who elect not to undergo radical prostatectomy or radiation therapy to evaluate risk factors which predict the transformation of early stage to clinically aggressive disease.
详细描述
Primary Objective: Evaluate risk factors which predict the transformation of early stage to clinically aggressive disease.
Intervention: None
Study Abstract: Environmental factors such as diet and cigarette smoking may play a role in predicting the progression of early stage prostate cancer to advance disease. The goal of this project is to establish an observational cohort of patients with early stage prostate cancer who elect not to undergo radical prostatectomy or radiation therapy to evaluate risk factors which predict the transformation of early stage to clinically aggressive disease.
A total of 1,000 US male veterans with early stage prostate cancer will be recruited to participate in the study. In order to maximize African-American participation, VA medical centers that serve large minority populations will be utilized for recruitment. Eligible participants must have an early stage prostate cancer diagnosis (T0-T2) with no known involved lymph nodes or metastases, and no prior history of cancer (with the exception of nonmelanoma skin cancer) or other major illness that would preclude long term participation. Individuals willing to participate will be administered a lifestyle questionnaire and a dietary assessment. The lifestyle survey ascertains baseline demographics, mode of cancer diagnosis, medical history, smoking, family history of prostate cancer, alcohol use, level of physical activity, and other potential risk factors for prostate cancer progression. Nutritional parameters will be measured through a self-administered, semi-quantitative food frequency questionnaire. A blood specimen will also be collected for genetic and biochemical research. Participants will be followed annually with additional lifestyle and dietary questionnaires.
Both surveys are currently being tested through a pilot project in a population of prostate cancer survivors to assess the feasibility of collecting diet and lifestyle data in veterans and to refine the study methods and recruitment strategies (the current versions of the surveys are included).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •US male veterans with early stage prostate cancer.
排除标准
- •Men will be excluded if they have prior history of other cancer within the last 5 years (with the exception of non-melanoma skin cancer) or other major illness that would preclude long-term participation.
结局指标
主要结局
The primary endpoint of the study will be prostate cancer mortality.
时间窗: approximately once a year
次要结局
未报告次要终点
