Randomized Trial of Ciprofloxacin Versus Observation for Men With Elevated Prostate Specific Antigen (PSA)

Randomized, Multi-Institution Trial of Ciprofloxacin Versus Observation for Men With an 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 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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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