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

Elevated Prostate Specific Antigen Clinical Trial

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

Status Terminated

Clinical Trial 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 Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Elevated Prostate Specific Antigen

• NCT number: NCT00840294
• Study type: Interventional
• Source: University of Chicago
• Status: Terminated
• Phase: Phase 3
• Start date: January 2009
• Completion date: May 2011