A Phase II, Double-Blind, Placebo-Controlled Prospective Randomized Clinical Trial Evaluating the Role of an Empiric 2-Week Course of Ciprofloxacin on Rates of Detection of Cancer by Prostate Biopsy in Men With Abnormal Serum Prostate Specific Antigen Found at Screening (PREP Trial)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Prostate cancer detection rates
研究概览
简要总结
This phase II trial studies ciprofloxacin compared to an inactive treatment (placebo) in diagnosing prostate cancer in patients undergoing removal of prostate cells or tissues for examination (biopsy). Ciprofloxacin is an antibiotic, a type of drug used to treat infections caused by bacteria. Giving ciprofloxacin to patients undergoing a prostate biopsy may help to lower abnormal prostate-specific antigen (PSA) levels caused by bacterial infection of the prostate gland and may or may not affect the detection rate of prostate cancer.
详细描述
PRIMARY OBJECTIVES:
I. To determine the non-inferiority of the rate of detection of prostate cancer in men with decreased serum PSA values treated with placebo compared to ciprofloxacin prior to prostate biopsy.
SECONDARY OBJECTIVES:
I. To compare the change in PSA from randomization to biopsy in men treated with ciprofloxacin versus those treated with placebo.
II. To compare the rates of post-biopsy complications (including duration of hematuria, hematochezia, hematospermia, fever > 101°F, and hospital admission rates related to biopsy, sepsis, and pain) between men treated with ciprofloxacin versus those treated with placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Abnormal serum PSA (total > 2.5 ng/ml or other clinically important biomarker parameters, including PSA velocity and density) associated with or without normal digital rectal examination
- •Men who have elected to proceed with a diagnostic prostate biopsy
- •Any prostate size
- •Willingness and ability to give informed consent
排除标准
- •History of prostate cancer
- •Urine culture positive for significant urinary tract infection (UTI)
- •A history of antibiotic use within one month prior to initial PSA level measurement
- •Allergy to fluoroquinolones
- •Currently taking imperative medications with significant drug-drug interaction with ciprofloxacin
- •Compromised renal function with estimated glomerular filtration rate (GFR) of < 30 ml/min/1.73m^2
研究组 & 干预措施
Arm II (placebo)
Patients receive placebo PO BID for 2 weeks.
干预措施: placebo (Other)
Arm I (ciprofloxacin)
Patients receive ciprofloxacin PO BID for 2 weeks.
干预措施: ciprofloxacin (Drug)
Arm I (ciprofloxacin)
Patients receive ciprofloxacin PO BID for 2 weeks.
干预措施: quality-of-life assessment (Other)
Arm I (ciprofloxacin)
Patients receive ciprofloxacin PO BID for 2 weeks.
干预措施: laboratory biomarker analysis (Other)
Arm II (placebo)
Patients receive placebo PO BID for 2 weeks.
干预措施: quality-of-life assessment (Other)
Arm II (placebo)
Patients receive placebo PO BID for 2 weeks.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Prostate cancer detection rates
时间窗: Up to 8 weeks
Will be compared between groups using a binomial test to compare rates in the two groups. Groups will also be compared using logistic regression models to adjust for any pre-treatment patient level characteristics.
次要结局
- Rates of post-biopsy complications (including duration of hematuria, hematochezia, hematospermia, fever > 101°F, and hospital admission rates related to biopsy, sepsis, and pain)(Up to 8 weeks)
- Change in PSA(Up to 8 weeks)