Randomized Trial of Ciprofloxacin Versus Observation for Men With Elevated Prostate Specific Antigen (PSA)
Information source: University of Chicago
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Specific Antigen
Intervention: Ciprofloxacin (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University of Chicago Official(s) and/or principal investigator(s):
Scott Eggener, MD, Principal Investigator, Affiliation: University of Chicago
Overall contact:
Jospephine Silvestre, RN, Phone: 773-702-0792, Email: jsilvest@surgery.bsd.uchicago.edu
Summary
The purpose of this study is to assess the impact of an empiric course of antibiotics for
men with an elevated PSA.
Clinical Details
Official title: Randomized, Multi-Institution Trial of Ciprofloxacin Versus Observation for Men With an Elevated Prostate Specific Antigen (PSA)
Study design: Cohort, Prospective
Primary outcome: To assess the impact of ciprofloxacin on the absolute and percent change in PSA from randomization to prostate biopsy
Secondary outcome: To assess the impact of ciprofloxacin on the overall infectious complications following prostate biopsy
Detailed description:
Study Objectives:
Primary Objective: To assess the impact of ciprofloxacin on the absolute and percent change
in PSA from randomization to prostate biopsy
Secondary Objective: To assess the impact of ciprofloxacin on the overall infectious
complications following prostate biopsy
The impact of observation and ciprofloxacin on PSA levels will be assessed by absolute
changes and percent PSA change. 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
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
Locations and Contacts
Jospephine Silvestre, RN, Phone: 773-702-0792, Email: jsilvest@surgery.bsd.uchicago.edu
The University of Chicago, Chicago, Illinois 60637, United States; Recruiting
Scott Eggener, MD, Phone: 773-702-5195, Email: seggener@surgery.bsd.uchicago.edu
Scott Eggener, MD, Principal Investigator
Additional Information
Starting date: January 2009
Last updated: February 9, 2009
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