Status:
TERMINATED
Randomized Trial of Ciprofloxacin Versus Observation for Men With Elevated Prostate Specific Antigen (PSA)
Lead Sponsor:
University of Chicago
Conditions:
Elevated Prostate Specific Antigen
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief 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.
Detailed Description
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 ciprofloxa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00840294
Start Date
January 1 2009
End Date
May 1 2011
Last Update
August 1 2014
Active Locations (1)
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1
The University of Chicago
Chicago, Illinois, United States, 60637