The Randomized Controlled Trial of Prostate Cancer Screening in Beijing, China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30,000
- 试验地点
- 1
- 主要终点
- detection of clinically significant prostate cancer （Gleason Score ≥7）
研究概览
简要总结
BROPCS is a randomized trial study comparing the effectiveness of traditional systematic biopsies and bpMRI followed targeted biopsies with PSA > 4ng/ml in initial screening.
详细描述
The aim of BROPCS study is to explore a suitable prostate cancer screening model for Chinese population, which can increase the specificity in early detection of prostate cancer without decreasing the sensitivity of clinically significant prostate cancers, and can reduce prostate cancer-specific mortality.This study will use a cluster randomized controlled trial method with a total of approximately 30,000 participants. The subjects will be randomly assigned to a control group (about 20,000 people) and a screening group (about 10,000 people), and some basic information will be obtained through a questionnaire survey. The screening group will undergo initial prostate-specific antigen (PSA) screening, and high-risk subjects (PSA > 4ng/ml) will be randomly assigned to two groups. The standard biopsy group will undergo traditional systematic biopsy, while the precision screening group will undergo further MRI examination and targeted fusion biopsy for those with positive MRI results.
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
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy men aged 60-75 with a life expectancy of more than 10 years;
- •Residing continuously in the community for more than 3 years and not previously diagnosed with prostate cancer;
- •Willing to participate in this project.
排除标准
- •Previously diagnosed with prostate cancer;
- •Previously diagnosed with any malignant tumor within the past 5 years;
- •Used medication within the past 3 months that can affect PSA values, mainly finasteride, dutasteride, and ketoconazole;
- •Recently had acute prostatitis, acute urinary retention, or underwent transurethral procedures (such as urethral dilation, urinary catheterization, cystoscopy, etc.) within the past week;
- •Have other serious illnesses or cannot perform activities of daily living independently.
结局指标
主要结局
detection of clinically significant prostate cancer （Gleason Score ≥7）
时间窗: At 2 months after the last included biopsy procedure
Cancers detected by pathological evaluation of biopsy specimen collected from the respective study arm
次要结局
- detection of clinically insignificant prostate cancer （Gleason Score 3+3）(At 2 months after the last included biopsy procedure)