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

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ClinicalTrials.gov Identifier: NCT00840294
Recruitment Status : Terminated (Combination of futility analysis and poor accrual)
First Posted : February 10, 2009
Results First Posted : August 1, 2014
Last Update Posted : August 1, 2014
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Elevated Prostate Specific Antigen Drug: Ciprofloxacin Phase 3

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Multi-Institution Trial of Ciprofloxacin Versus Observation for Men With an Elevated Prostate Specific Antigen (PSA)
Study Start Date : January 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Observation
Observation only for 2 weeks
Active Comparator: Antibiotic
Ciprofloxacin 500 mg twice daily for 2 weeks
 Drug: Ciprofloxacin
Other Name: Cipro


Outcome Measures
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Primary Outcome Measures :
  1. Change in PSA Level From Baseline [ Time Frame: At baseline and 21-45 days after randomization ]

    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).



Secondary Outcome Measures :
  1. Overall Infectious Complication Rate Following Prostate Biopsy [ Time Frame: Within 24 hours of biopsy ]
    To assess the impact of ciprofloxacin on the overall infectious complication rate following prostate biopsy


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00840294     History of Changes
Other Study ID Numbers: 16368B
First Posted: February 10, 2009    Key Record Dates
Results First Posted: August 1, 2014
Last Update Posted: August 1, 2014
Last Verified: July 2014

Keywords provided by University of Chicago:
Men with Elevated PSA

Additional relevant MeSH terms:
Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors