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

• Status: Terminated
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Treatments: Ciprofloxacin

Criteria

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