Randomized Trial of Ciprofloxacin Versus Observation for Men With Elevated Prostate Specific Antigen (PSA)

Elevated Prostate Specific Antigen Clinical Trial

Official title:

Randomized, Multi-Institution Trial of Ciprofloxacin Versus Observation for Men With an Elevated Prostate Specific Antigen (PSA)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00840294
• Other study ID #: 16368B
• Status: Terminated
• Phase: Phase 3
• First received: February 9, 2009
• Last updated: July 7, 2014
• Start date: January 2009
• Est. completion date: May 2011

Study information

• Verified date: July 2014
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 85
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Elevated Prostate Specific Antigen

Intervention

Drug:
• Ciprofloxacin

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Overall Infectious Complication Rate Following Prostate Biopsy	To assess the impact of ciprofloxacin on the overall infectious complication rate following prostate biopsy	Within 24 hours of biopsy	No