Randomized Trial of Ciprofloxacin Versus Observation for Men With Elevated Prostate Specific Antigen (PSA)
Information source: University of Chicago
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Elevated Prostate Specific Antigen
Intervention: Ciprofloxacin (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: University of Chicago Official(s) and/or principal investigator(s): Scott Eggener, MD, Principal Investigator, Affiliation: University of Chicago
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.
Clinical Details
Official title: Randomized, Multi-Institution Trial of Ciprofloxacin Versus Observation for Men With an Elevated Prostate Specific Antigen (PSA)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in PSA Level From Baseline
Secondary outcome: Overall Infectious Complication Rate Following Prostate Biopsy
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 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.
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
The University of Chicago, Chicago, Illinois 60637, United States
Additional Information
Starting date: January 2009
Last updated: July 7, 2014
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