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

Stopped early · Phase 3

Conditions studied: Elevated Prostate Specific Antigen

In brief

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.

Key facts

Study ID

NCT00840294

Run by

University of Chicago

People needed

85

Starts

2009-01-01

Expected to finish

2011-05-01

Last updated by the study team

2014-08-01

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The University of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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