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

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
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- 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).
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

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
United States, Illinois | |
The University of Chicago | |
Chicago, Illinois, United States, 60637 |
Principal Investigator: | Scott Eggener, MD | University of Chicago |
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 |