Randomized Trial of Ciprofloxacin Versus Observation for Men With Elevated Prostate Specific Antigen (PSA)

Phase 3

Terminated

• Conditions: Elevated Prostate Specific Antigen
• Interventions: Drug: Ciprofloxacin

• Registration Number: NCT00840294
• Lead Sponsor: University of Chicago

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-02-09
• Study First Submitted QC: 2009-02-09
• Study First Posted: 2009-02-10
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2014-07
• Results First Submitted: 2014-07-07
• Results First Submitted QC: 2014-07-07
• Last Update Submitted: 2014-07-07
• Results First Posted: 2014-08-01
• Last Update Posted: 2014-08-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 85

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antibiotic	Ciprofloxacin	Ciprofloxacin 500 mg twice daily for 2 weeks

Primary Outcome Measures

Name	Time	Method
Change in PSA Level From Baseline	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).

Secondary Outcome Measures

Name	Time	Method
Overall Infectious Complication Rate Following Prostate Biopsy	Within 24 hours of biopsy	To assess the impact of ciprofloxacin on the overall infectious complication rate following prostate biopsy

Trial Locations

Locations (1)

The University of Chicago; 🇺🇸 Chicago, Illinois, United States