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

Prostate Cancer Clinical Trial

Official title: 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)

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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 prostate biopsy.

SECONDARY OBJECTIVES:

I. To compare the change in PSA from randomization to biopsy in men treated with ciprofloxacin versus those treated with placebo.

II. To compare the rates of post-biopsy complications (including duration of hematuria, hematochezia, hematospermia, fever > 101°F, and hospital admission rates related to biopsy, sepsis, and pain) between men treated with ciprofloxacin versus those treated with placebo.

TERTIARY OBJECTIVES:

I. To determine if benign prostatic hyperplasia (BPH) or erectile dysfunction are associated with abnormal PSA or prostatic inflammation reported in the biopsy specimen.

II. To determine the correlation between change in PSA from randomization to biopsy and urinalysis pre- and post-ciprofloxacin versus placebo.

III. To determine the correlation between change in PSA and prostate massage pre- and post-ciprofloxacin versus placebo.

IV. To determine the qualitative and quantitative difference in flora (ciprofloxacin resistant organisms) obtained from rectal swab pre- and post- two week course of ciprofloxacin vs. placebo.

V. To correlate prostate symptom severity (International Prostate Symptom Score [IPSS]) with erectile function (International Index of Erectile Function [IIEF-5]) at baseline.

VI. To correlate urinary, prostate massage or rectal swab findings to pathology findings including cancer, inflammation, prostatic intra-epithelial neoplasia (PIN), atypical acinar proliferation (ASAP) or other findings at the end of the study.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive ciprofloxacin orally (PO) twice daily (BID) for 2 weeks.

ARM II: Patients receive ciprofloxacin PO BID for 2 weeks. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT02252978
• Study type: Interventional
• Source: Wake Forest University Health Sciences
• Status: Withdrawn
• Phase: Phase 2
• Start date: July 2016
• Completion date: July 2016