Randomized Trial of Ciprofloxacin Versus Observation for Men With Elevated Prostate Specific Antigen (PSA)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized, Multi-Institution Trial of Ciprofloxacin Versus Observation for Men With an Elevated Prostate Specific Antigen (PSA)|
- Change in PSA Level From Baseline [ Time Frame: At baseline and 21-45 days after randomization ] [ Designated as safety issue: No ]
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).
- Overall Infectious Complication Rate Following Prostate Biopsy [ Time Frame: Within 24 hours of biopsy ] [ Designated as safety issue: No ]To assess the impact of ciprofloxacin on the overall infectious complication rate following prostate biopsy
|Study Start Date:||January 2009|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
No Intervention: Observation
Observation only for 2 weeks
Active Comparator: Antibiotic
Ciprofloxacin 500 mg twice daily for 2 weeks
Other Name: Cipro
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00840294
|United States, Illinois|
|The University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Scott Eggener, MD||University of Chicago|