Randomized, Multi-Institution Trial of Ciprofloxacin Versus Observation for Men With an Elevated Prostate Specific Antigen (PSA)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Change in PSA Level From Baseline
研究概览
简要总结
The purpose of this study is to assess the impact of an empiric course of antibiotics for men with an elevated prostate-specific antigen (PSA) level.
详细描述
Study Objectives:
Primary Objective: To assess the impact of ciprofloxacin on the change in PSA from baseline/randomization to prostate biopsy
Secondary Objective: To assess the impact of ciprofloxacin on the overall infectious complications following prostate biopsy
The impact of observation versus ciprofloxacin on PSA levels will be assessed by PSA change from baseline. The first PSA measurement will be at the study entry and randomization. The second PSA measurement will be immediately prior to prostate biopsy, which will occur 21-45 days following randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men 18 yrs. or older
- •An elevated PSA (>2.5 ng/ml) and normal digital rectal exam
- •Have elected to proceed with a diagnostic 12-core prostate biopsy
排除标准
- •Previous prostate biopsy
- •History of prostate cancer
- •Urinary tract infections or prostatitis within one year of study entry
- •antibiotic use within one month prior to PSA level
- •pyuria or bacteruria on urinalysis
- •allergy to fluoroquinolones
研究组 & 干预措施
Antibiotic
Ciprofloxacin 500 mg twice daily for 2 weeks
干预措施: Ciprofloxacin (Drug)
结局指标
主要结局
Change in PSA Level From Baseline
时间窗: At baseline and 21-45 days after randomization
To assess the impact of ciprofloxacin on the change in PSA from baseline/randomization to prostate biopsy which occurs 21-45 days after randomization. Due to the skewness of the data, the log transformation was used and the outcome used was the log(PSA level post-treatment, at time of biopsy) - log(PSA level baseline).
次要结局
- Overall Infectious Complication Rate Following Prostate Biopsy(Within 24 hours of biopsy)