Ciprofloxacin Compared to Placebo in Diagnosing Prostate Cancer in Patients Undergoing Prostate Biopsy
NCT ID: NCT02252978
Last Updated: 2018-07-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2016-07-31
2016-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
TRIPLE
Study Groups
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Arm I (ciprofloxacin)
Patients receive ciprofloxacin PO BID for 2 weeks.
ciprofloxacin
Given PO
quality-of-life assessment
Ancillary studies
laboratory biomarker analysis
Correlative studies
Arm II (placebo)
Patients receive placebo PO BID for 2 weeks.
placebo
Given PO
quality-of-life assessment
Ancillary studies
laboratory biomarker analysis
Correlative studies
Interventions
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ciprofloxacin
Given PO
placebo
Given PO
quality-of-life assessment
Ancillary studies
laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Men who have elected to proceed with a diagnostic prostate biopsy
* Any prostate size
* Willingness and ability to give informed consent
Exclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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K. C. Balaji
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Veterans Administration Medical Center.
Salisbury, North Carolina, United States
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States
Countries
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Other Identifiers
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NCI-2014-01594
Identifier Type: REGISTRY
Identifier Source: secondary_id
CCCWFU 99712
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00028209
Identifier Type: -
Identifier Source: org_study_id
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