Randomized, Multi-Institution Trial of Ciprofloxacin Versus Observation for Men With an Elevated Prostate Specific Antigen (PSA)

University of Chicago1 site in 1 country85 target enrollmentJanuary 2009

ConditionsElevated Prostate Specific Antigen

InterventionsCiprofloxacin

DrugsCiprofloxacin

Overview

Phase: Phase 3
Intervention: Ciprofloxacin
Conditions: Elevated Prostate Specific Antigen
Sponsor: University of Chicago
Enrollment: 85
Locations: 1
Primary Endpoint: Change in PSA Level From Baseline
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 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.

Registry

clinicaltrials.gov

Start Date

January 2009

End Date

May 2011

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

University of Chicago

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Antibiotic

Ciprofloxacin 500 mg twice daily for 2 weeks

Intervention: Ciprofloxacin

Outcomes

Primary Outcomes

Change in PSA Level From Baseline

Time Frame: At baseline and 21-45 days after randomization

To assess the impact of ciprofloxacin on the change in PSA from baseline/randomization to prostate biopsy which occurs 21-45 days after randomization. Due to the skewness of the data, the log transformation was used and the outcome used was the log(PSA level post-treatment, at time of biopsy) - log(PSA level baseline).