A Clinical Study on the Efficiency of Prostate Cancer Screening by the Combination of Serum PSA Assay，Multi-parametric MRI and Targeted Prostate Biopsy Among Males in Nanjing
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Incidence of prostate cancer
研究概览
简要总结
The study aims to investigate the incidence of prostate cancer among males in Nanjing and whether a combination of PSA, multi-parametric MRI and targeted biopsy is a feasible approach for screening prostate cancer in China.
详细描述
The investigators are going to collect serum samples and clinical information from men aged ≥50 years taking physical examination in community health service centers in Nanjing. The investigators will propose mpMRI for those with serum PSA ≥4 ng/mL. Transperineal systematic biopsy (TPSB) combined with MRI /ultrasound fusion targeted biopsy (TB) will be offered for those scored ≥3 on the Prostate Imaging-Reporting and Data System Version 2 (PI-RADS v2). TPSB alone will be offered for those scored <3 and serum PSA ≥10 ng/mL. Subjects with serum PSA between 4 ng/mL and 10 ng/mL and PI-RADS score <3 points will be referred to follow-up examinations every 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •(Eastern Cooperative Oncology Group)ECOG grade: 0-1
- •Normal organic function indexes:
- •(absolute neutrophil count)ANC ≧1.5×109/L
- •(platelet count)PLT ≧100×109/L
- •Hb ≧90 g/L
- •(total bilirubin)TBIL ≦1.5×ULN
- •(aspartate aminotransferase)ALT≦2.5×ULN
- •(alanine aminotransferase)AST ≦2.5×ULN
- •(blood urea nitrogen)BUN (orUREA) and Cr ≦1.5×ULN
排除标准
- •Former serum PSA detection
- •Having took Proscar in the past 3 months
- •Suffered from any other malignant tumor in the past 5 years
- •History of acute urinary retention, acute or chronic bacterial or abacterial prostatitis within 6 weeks or other recent infection of the urinary system
- •Having took Proscar in the past 3 months
- •Suffered from any other malignant tumor in the past 5 years
- •History of acute urinary retention, acute or chronic bacterial or abacterial prostatitis within 6 weeks or other recent infection of the urinary system
结局指标
主要结局
Incidence of prostate cancer
时间窗: 3 years
Incidence of prostate cancer among males ≥50 years old
次要结局
- Number of participants with different gleason scores(3 years)
- Number of participants with different clinical stages(3 years)
- Number of participants with different risk groups(3 years)
- Number of participants with different prognostic stage groups(3 years)
研究者
Hongqian Guo
Executive officer of Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School