Clinical trial NCT02252978: Ciprofloxacin Compared to Placebo in Diagnosing Prostate Cancer in Patients Undergoing Prostate Biopsy
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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-09-30
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Prostate cancer detection rates
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Change in PSA
timeFrame: Up to 8 weeks
measure: Rates of post-biopsy complications (including duration of hematuria, hematochezia, hematospermia, fever > 101°F, and hospital admission rates related to biopsy, sepsis, and pain)
timeFrame: Up to 8 weeks
Other outcomes:
measure: BPH or erectile dysfunction
timeFrame: Up to 8 weeks
measure: Change in urinalysis pre- and post-treatment
timeFrame: Up to 8 weeks
measure: Change in prostate massage outcomes
timeFrame: Up to 8 weeks
measure: Change in flora levels
timeFrame: 2 weeks
measure: Prostate symptom severity (IPSS) and erectile function (IIEF-5)
timeFrame: Day 1
measure: Pathology findings
timeFrame: Up to 1 month
Locations:
city: Salisbury
country: United States
facility: Veterans Administration Medical Center.
state: North Carolina
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: K. C. Balaji
role: PRINCIPAL_INVESTIGATOR
References: