Randomized Trial of Ciprofloxacin Versus Observation for Men With Elevated Prostate Specific Antigen (PSA)
NCT ID: NCT00840294
Last Updated: 2014-08-01
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
85 participants
INTERVENTIONAL
2009-01-31
2011-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Observation
Observation only for 2 weeks
No interventions assigned to this group
Antibiotic
Ciprofloxacin 500 mg twice daily for 2 weeks
Ciprofloxacin
Interventions
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Ciprofloxacin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Scott Eggener, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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The University of Chicago
Chicago, Illinois, United States
Countries
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Other Identifiers
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16368B
Identifier Type: -
Identifier Source: org_study_id
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