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 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
85
The University of Chicago
Chicago, Illinois, United States
Change in PSA Level From Baseline
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).
Time frame: At baseline and 21-45 days after randomization
Overall Infectious Complication Rate Following Prostate Biopsy
To assess the impact of ciprofloxacin on the overall infectious complication rate following prostate biopsy
Time frame: Within 24 hours of biopsy
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