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:
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

February 9, 2009
July 7, 2014
January 2009
May 2011   (final data collection date for primary outcome measure)
Change in PSA Level From Baseline [ Time Frame: At baseline and 21-45 days after randomization ] [ Designated as safety issue: No ]

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).

To assess the impact of ciprofloxacin on the absolute and percent change in PSA from randomization to prostate biopsy [ Time Frame: 21-45 days after randomizatoin ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00840294 on ClinicalTrials.gov Archive Site
Overall Infectious Complication Rate Following Prostate Biopsy [ Time Frame: Within 24 hours of biopsy ] [ Designated as safety issue: No ]
To assess the impact of ciprofloxacin on the overall infectious complication rate following prostate biopsy
To assess the impact of ciprofloxacin on the overall infectious complications following prostate biopsy [ Time Frame: 21-45 days after randomization ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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)

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Elevated Prostate Specific Antigen
Drug: Ciprofloxacin
Other Name: Cipro
  • No Intervention: Observation
    Observation only for 2 weeks
  • Active Comparator: Antibiotic
    Ciprofloxacin 500 mg twice daily for 2 weeks
    Intervention: Drug: Ciprofloxacin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
85
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00840294
16368B
No
University of Chicago
University of Chicago
Not Provided
Principal Investigator: Scott Eggener, MD University of Chicago
University of Chicago
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP