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

Sponsor:	University of Chicago
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00840294

Purpose

The purpose of this study is to assess the impact of an empiric course of antibiotics for men with an elevated PSA.

Condition	Intervention	Phase
Prostate Specific Antigen	Drug: Ciprofloxacin	Phase III

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Randomized, Multi-Institution Trial of Ciprofloxacin Versus Observation for Men With an Elevated Prostate Specific Antigen (PSA)

Resource links provided by NLM:

Drug Information available for: Ciprofloxacin Ciprofloxacin hydrochloride Ciprofloxacin lactate

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:

To assess the impact of ciprofloxacin on the absolute and percent change in PSA from randomization to prostate biopsy [ Time Frame: 21-45 days after randomizatoin ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the impact of ciprofloxacin on the overall infectious complications following prostate biopsy [ Time Frame: 21-45 days after randomization ] [ Designated as safety issue: No ]

Estimated Enrollment:	88
Study Start Date:	January 2009
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
2 Observation
1 Ciprofloxacin	Drug: Ciprofloxacin 500 milligrams twice a day for 14 days Other Name: Cipro

Detailed Description:

Study Objectives:

Primary Objective: To assess the impact of ciprofloxacin on the absolute and percent change in PSA from randomization to prostate biopsy

Secondary Objective: To assess the impact of ciprofloxacin on the overall infectious complications following prostate biopsy

The impact of observation and ciprofloxacin on PSA levels will be assessed by absolute changes and percent PSA change. 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Men with Elevated Prostate Specific Antigen (PSA)

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00840294

Contacts

Contact: Ann Strasbaugh, RN	773-702-0792	astrasbau@surgery.bsd.uchicago.edu
Contact: Maria Newsome	773-702-0792	mnewsome@uchicago.edu

Locations

United States, Illinois
The University of Chicago	Recruiting
Chicago, Illinois, United States, 60637
Contact: Scott Eggener, MD 773-702-5195 seggener@surgery.bsd.uchicago.edu
Principal Investigator: Scott Eggener, MD

Sponsors and Collaborators

University of Chicago

Investigators

Principal Investigator:

Scott Eggener, MD

University of Chicago

More Information

No publications provided

Responsible Party:	Scott Eggener, MD, University of Chicago
ClinicalTrials.gov Identifier:	NCT00840294 History of Changes
Other Study ID Numbers:	16368B
Study First Received:	February 9, 2009
Last Updated:	February 21, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Chicago:

Men with Elevated PSA

Additional relevant MeSH terms:

Ciprofloxacin
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012