Comparision of Transrectal vs Transperineal biopsy in suspected carcinoma prostate - an open label non inferior randomised control trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- •PRIMARY OBJECTIVE
研究概览
简要总结
Aim :
Comparision of transrectal and transperineal biopsy in detection rate, infectious complication rate and non infectious complication rate for suspected carcinoma prostate.
Research question :
Can use of transperineal route for prostate biopsy reduce post biopsy complication rate as compared with transrectal biopsy.
Hypothesis :
Transrectal route of prostate biopsy has less complication rate with similar detection rate as compared with transrectal biopsy for suspected carcinoma prostate.
Primary objective :
To compare the infectious complication rate between transperineal and transrectal biopsy
Secondary objective :
To compare the non infectious complication rates and detection rate between transperineal and transrectal biopsy for ca prostate
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 40.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Male
入选标准
- •Adult males (40- 80 Years) who have indication of prostrate biopsy for detection of suspected prostrate CA with elevated PSA levels, abnormal DRE findings and/or abnormal TRUS/mpMRI findings.
排除标准
- •Previous history of CA prostrate, acute prostatitis or proven urinary tract infection.
结局指标
主要结局
•PRIMARY OBJECTIVE
时间窗: 30 DAYS
To compare the infectious complication rate between transperineal and transrectal biopsy
时间窗: 30 DAYS
次要结局
- •SECONDARY OBJECTIVE(To compare the non-infectious complication rates and detection rate between transperineal and transrectal biopsy for CA prostrate.)