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

This study has been terminated.
(Combination of futility analysis and poor accrual)
Sponsor:
Information provided by (Responsible Party):
Scott Eggener, University of Chicago
ClinicalTrials.gov Identifier:
NCT00840294
First received: February 9, 2009
Last updated: October 10, 2012
Last verified: October 2012
History of Changes
  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 3

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:

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 ]

Enrollment: 77
Study Start Date: January 2009
Study Completion Date: May 2011
Primary Completion Date: May 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

Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Scott Eggener, MD University of Chicago
  More Information

No publications provided

Responsible Party: Scott Eggener, Asst Prof Surgery, University of Chicago
ClinicalTrials.gov Identifier: NCT00840294     History of Changes
Other Study ID Numbers: 16368B
Study First Received: February 9, 2009
Last Updated: October 10, 2012
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 May 23, 2013