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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

Page last updated: August 23, 2015

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