Status:
WITHDRAWN
Ciprofloxacin Compared to Placebo in Diagnosing Prostate Cancer in Patients Undergoing Prostate Biopsy
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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)...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the non-inferiority of the rate of detection of prostate cancer in men with decreased serum PSA values treated with placebo compared to ciprofloxacin prior to pros...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02252978
Start Date
July 1 2016
End Date
July 1 2016
Last Update
July 5 2018
Active Locations (2)
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1
Veterans Administration Medical Center.
Salisbury, North Carolina, United States, 28144
2
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States, 27157