Study Stopped
Combination of futility analysis and poor accrual
Randomized Trial of Ciprofloxacin Versus Observation for Men With Elevated Prostate Specific Antigen (PSA)
Randomized, Multi-Institution Trial of Ciprofloxacin Versus Observation for Men With an Elevated Prostate Specific Antigen (PSA)
1 other identifier
interventional
85
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 9, 2009
CompletedFirst Posted
Study publicly available on registry
February 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
August 1, 2014
CompletedAugust 1, 2014
July 1, 2014
2.3 years
February 9, 2009
July 7, 2014
July 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in PSA Level From Baseline
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).
At baseline and 21-45 days after randomization
Secondary Outcomes (1)
Overall Infectious Complication Rate Following Prostate Biopsy
Within 24 hours of biopsy
Study Arms (2)
Observation
NO INTERVENTIONObservation only for 2 weeks
Antibiotic
ACTIVE COMPARATORCiprofloxacin 500 mg twice daily for 2 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Chicago
Chicago, Illinois, 60637, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Early termination due to poor accrual and interim futility analysis.
Results Point of Contact
- Title
- Scott Eggener
- Organization
- University of Chicago
Study Officials
- PRINCIPAL INVESTIGATOR
Scott Eggener, MD
University of Chicago
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2009
First Posted
February 10, 2009
Study Start
January 1, 2009
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
August 1, 2014
Results First Posted
August 1, 2014
Record last verified: 2014-07