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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Elevated Prostate Specific Antigen

Intervention / Treatment
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* Drug: Ciprofloxacin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Observation<br>Observation only for 2 weeks | |
| Active Comparator: Antibiotic<br>Ciprofloxacin 500 mg twice daily for 2 weeks | Drug: Ciprofloxacin<br> <br> * Other names: Cipro;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PSA Level From Baseline | 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). | At baseline and 21-45 days after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Infectious Complication Rate Following Prostate Biopsy | To assess the impact of ciprofloxacin on the overall infectious complication rate following prostate biopsy | Within 24 hours of biopsy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Men with Elevated PSA