Ciprofloxacin Compared to Placebo in Diagnosing Prostate Cancer in Patients Undergoing Prostate Biopsy

• Status: Withdrawn
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

This phase II trial studies ciprofloxacin compared to an inactive treatment (placebo) in diagnosing prostate cancer in patients undergoing removal of prostate cells or tissues for examination (biopsy). Ciprofloxacin is an antibiotic, a type of drug used to treat infections caused by bacteria. Giving ciprofloxacin to patients undergoing a prostate biopsy may help to lower abnormal prostate-specific antigen (PSA) levels caused by bacterial infection of the prostate gland and may or may not affect the detection rate of prostate cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Ciprofloxacin

Criteria

Inclusion Criteria:

• Abnormal serum PSA (total > 2.5 ng/ml or other clinically important biomarker parameters, including PSA velocity and density) associated with or without normal digital rectal examination

• Men who have elected to proceed with a diagnostic prostate biopsy

• Any prostate size

• Willingness and ability to give informed consent

Exclusion Criteria:

• History of prostate cancer

• Urine culture positive for significant urinary tract infection (UTI)

• A history of antibiotic use within one month prior to initial PSA level measurement

• Allergy to fluoroquinolones

• Currently taking imperative medications with significant drug-drug interaction with ciprofloxacin

• Compromised renal function with estimated glomerular filtration rate (GFR) of < 30 ml/min/1.73m^2