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Trial record 2 of 7 for:    eggener

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:
ClinicalTrials.gov Identifier:
NCT00840294
First Posted: February 10, 2009
Last Update Posted: August 1, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Chicago
  Purpose
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 Intervention Phase
Elevated Prostate Specific Antigen Drug: Ciprofloxacin Phase 3

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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:
  • 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


Enrollment: 85
Study Start Date: January 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Observation
Observation only for 2 weeks
Active Comparator: Antibiotic
Ciprofloxacin 500 mg twice daily for 2 weeks
Drug: Ciprofloxacin
Other Name: Cipro

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00840294     History of Changes
Other Study ID Numbers: 16368B
First Submitted: February 9, 2009
First Posted: February 10, 2009
Results First Submitted: July 7, 2014
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