Ciprofloxacin Compared to Placebo in Diagnosing Prostate Cancer in Patients Undergoing Prostate Biopsy
NCT02252978 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2018-07-05
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.
Conditions
Interventions
- DRUG
-
Given PO
- OTHER
-
placebo
Given PO
- OTHER
-
quality-of-life assessment
Ancillary studies
- OTHER
-
laboratory biomarker analysis
Correlative studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Wake Forest University Health Sciences
lead OTHER
Principal Investigators
-
K. C. Balaji · Wake Forest University Health Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-07-31
- Primary Completion
- 2016-07-31
- Completion
- 2016-07-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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