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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:
University of Chicago
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00840294
First received: February 9, 2009
Last updated: July 7, 2014
Last verified: July 2014
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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| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00840294
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
| Responsible Party: | University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00840294 History of Changes |
| Other Study ID Numbers: |
16368B |
| Study First Received: | February 9, 2009 |
| Results First Received: | July 7, 2014 |
| Last Updated: | July 7, 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 |
ClinicalTrials.gov processed this record on September 21, 2017