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



Status:Not yet recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2015

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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)

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.

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
We found this trial at
2
sites
Salisbury, North Carolina 28144
Principal Investigator: Kethandapatti C. Balaji
Phone: 336-716-4131
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Medical Center Boulevard
Winston-Salem, North Carolina 27157
336-716-2255
Principal Investigator: Kethandapatti C. Balaji
Phone: 336-716-4131
Comprehensive Cancer Center of Wake Forest University Our newly expanded Comprehensive Cancer Center is the...
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Winston-Salem, NC
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