Screening for Prostate Cancer Among Those Initial Prostate-specific Antigen Value Between 2.5 and 4.0 ng/mL
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 232
- 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 evaluate the detection rate and characteristics of prostate cancer among males with PSA values between 2.5 and 4.0 ng/mL in Nanjing, meanwhile, to access the effectiveness of conducting multi-parametric MRI (mpMRI) after PSA assay.
详细描述
The investigators are going to collect serum samples and clinical information from men aged ≥50 years in community health service centers in Nanjing. The investigators will propose mpMRI for those met our criteria of PSA values between 2.5 and 4.0 ng/ml. Transperineal systematic biopsy and MRI/ultrasound fusion targeted biopsy will be offered for those who scored ≥3 points on the Prostate Imaging-Reporting and Data System Version 2 (PI-RADS v2). Follow-up examinations annually will be offered for those with a PI-RADS score <3. Sequences obtained while conducting mpMRI included T2-weighted imaging, diffusion-weighted imaging, and dynamic contrast-enhanced using a 3.0-T system.
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
- •PSA between 2.5 and 4.0ng/ml
- •(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
结局指标
主要结局
Incidence of prostate cancer
时间窗: 3 years
among PSA between 2.5 and 4.0 ng/ml
次要结局
未报告次要终点
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