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

The University of Chicago

Status and phase: Terminated; Phase 3

Conditions: Elevated Prostate Specific Antigen

Treatments: Drug: Ciprofloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT00840294

16368B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 2 patient groups

Observation

No Intervention group

Description:

Observation only for 2 weeks

Antibiotic

Active Comparator group

Description:

Ciprofloxacin 500 mg twice daily for 2 weeks

Treatment:

Drug: Ciprofloxacin