Prostate Cancer Risk Assessment Using Genetic Markers in General Practice
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5,000
- 试验地点
- 2
- 主要终点
- Number of low risk patients who get a PSA test
研究概览
简要总结
The preferred method for early detection of prostate cancer (PCa) in older men with family history is the Prostate Specific Antigen test (PSA test), although the method is imprecise. It produces a high number of false-positive results and increases the risk of over-diagnosis and over-treatment. Yet, an increasing number of men get the PSA test as part of unsystematic screening. Genetic risk assessment may be a better way to identify men with low risk of PCa. The main study hypothesis is that genetic information about low risk of PCa can reduce the number of patients who get a PSA test as part of unsystematic screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •patients who receive a PSA test
排除标准
- •age over 80 years
- •elevated PSA-level (> 4,0 ng/ml) concurrently or within previous 2 years
- •prostate or bladder disease
- •prostate cancer
- •non-Caucasians
- •do not speak and understand Danish
结局指标
主要结局
Number of low risk patients who get a PSA test
时间窗: 1 year, 2 years
The primary objective of this study is to evaluate the impact on use of PSA tests of introducing genetic PCa risk assessment in general practice.
次要结局
未报告次要终点