Ciprofloxacin Compared to Placebo in Diagnosing Prostate Cancer in Patients Undergoing Prostate Biopsy
Withdrawn before enrolling · Phase 2 · Has a placebo group
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT02252978
- Run by
- Wake Forest University Health Sciences
- People needed
- 0
- Starts
- 2016-07-01
- Expected to finish
- 2016-07-01
- Last updated by the study team
- 2018-07-05
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Veterans Administration Medical Center. — Salisbury, North Carolina, United States
- Comprehensive Cancer Center of Wake Forest University — Winston-Salem, North Carolina, United States
Full record on ClinicalTrials.gov
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