Clinical trial · Interventional
Ciprofloxacin Compared to Placebo in Diagnosing Prostate Cancer in Patients Undergoing Prostate Biopsy
A Phase II, Double-Blind, Placebo-Controlled Prospective Randomized Clinical Trial Evaluating the Role of an Empiric 2-Week Course of Ciprofloxacin on Rates of Detection of Cancer by Prostate Biopsy in Men With Abnormal Serum Prostate Specific Antigen Found at Screening (PREP Trial)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No funding support
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ciprofloxacin | Drug | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
| quality-of-life assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (ciprofloxacin)
- description
- Patients receive ciprofloxacin PO BID for 2 weeks.
- interventionNames
- Drug: ciprofloxacin
- Other: quality-of-life assessment
- Other: laboratory biomarker analysis
- type
- PLACEBO_COMPARATOR
- label
- Arm II (placebo)
- description
- Patients receive placebo PO BID for 2 weeks.
- interventionNames
- Other: placebo
- Other: quality-of-life assessment
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Prostate cancer detection rates
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available