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

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.

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