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Trial record 44 of 121 for:    prostate cancer AND prostate cancer screening | ( Map: United States )

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

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ClinicalTrials.gov Identifier: NCT02252978
Recruitment Status : Withdrawn (No funding support)
First Posted : September 30, 2014
Last Update Posted : July 4, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: ciprofloxacin Other: placebo Other: quality-of-life assessment Other: laboratory biomarker analysis Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
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)
Actual Study Start Date : July 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm I (ciprofloxacin)
Patients receive ciprofloxacin PO BID for 2 weeks.
Drug: ciprofloxacin
Given PO
Other Names:
  • Cipro
  • CPFX

Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

Other: laboratory biomarker analysis
Correlative studies

Placebo Comparator: Arm II (placebo)
Patients receive placebo PO BID for 2 weeks.
Other: placebo
Given PO
Other Name: PLCB

Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

Other: laboratory biomarker analysis
Correlative studies




Primary Outcome Measures :
  1. Prostate cancer detection rates [ Time Frame: Up to 8 weeks ]
    Will be compared between groups using a binomial test to compare rates in the two groups. Groups will also be compared using logistic regression models to adjust for any pre-treatment patient level characteristics.


Secondary Outcome Measures :
  1. Change in PSA [ Time Frame: Up to 8 weeks ]
    The data will be analyzed on a logarithmic scale to stabilize the variance. The change in log PSA from randomization to biopsy will be compared between the two groups using a two-sample t-test. In addition, the baseline log PSA levels will be compared between the two groups and if they are found to be imbalanced a 1-way analysis of covariance will be used to compare groups by including the baseline pre-randomization log-PSA value as the covariate in the model.

  2. Rates of post-biopsy complications (including duration of hematuria, hematochezia, hematospermia, fever > 101°F, and hospital admission rates related to biopsy, sepsis, and pain) [ Time Frame: Up to 8 weeks ]
    Will be compared between groups using Chi-square tests (or Fisher's Exact tests if the expected cell counts are below 5).


Other Outcome Measures:
  1. BPH or erectile dysfunction [ Time Frame: Up to 8 weeks ]
    In order to determine if BPH or erectile dysfunction are associated with abnormal PSA or prostatic inflammation reported in the biopsy specimen, 2x2 Chi Square tests will be used where each measure will be dichotomized. In addition, the consistency of these associations across the two treatment groups will be examined using a 3-way table and examining the Breslow Day test to see whether the odds ratios for each treatment are comparable.

  2. Change in urinalysis pre- and post-treatment [ Time Frame: Up to 8 weeks ]
    In order to determine the correlation between change in PSA from randomization to biopsy and urinalysis pre- and post-ciprofloxacin, the Pearson correlations of the change in PSA with white blood cells pre- and post-ciprofloxacin vs. placebo will be estimated. If the data is found to be non-normal the Spearman rank correlations will be used for this analysis.

  3. Change in prostate massage outcomes [ Time Frame: Up to 8 weeks ]
    The correlation between change in PSA and prostate massage pre- and post-ciprofloxacin vs placebo will be determined. Will examine whether there is a significant difference in PSA changes between the ciprofloxacin group and placebo group for different prostate massage outcomes using a 2-way analysis of variance (ANOVA) model. Will consider creating contrasts within the ANOVA model to test whether there is an ordered (possibly linear) relationship between levels of prostate massage and PSA change values (i.e., fitting a one-degree of freedom contrast within the ANOVA models).

  4. Change in flora levels [ Time Frame: 2 weeks ]
    In order to determine the qualitative and quantitative difference in flora obtained from rectal swab pre- and post- two week course of ciprofloxacin vs. placebo 2-sample t-tests will be used to compare the change in these measures (for quantitative measures) and 2x2 Chi-Square tests to examine qualitative changes (Improve Yes/no by treatment group).

  5. Prostate symptom severity (IPSS) and erectile function (IIEF-5) [ Time Frame: Day 1 ]
    To assess the correlation between prostate symptom severity (IPSS) and erectile function (IIEF-5) at baseline to ciprofloxacin or placebo treatment, an analysis of covariance model will be fit that examines the follow-up measure (IPSS) as the outcome, with the treatment indicator and IIEF-5 measure as predictors and their interaction included to see if the relationship depends on treatment.

  6. Pathology findings [ Time Frame: Up to 1 month ]
    In order to correlate urinary, prostate massage or rectal swab findings to pathology findings including cancer, inflammation, prostatic intra-epithelial neoplasia, atypical acinar proliferation or other findings will either estimate Pearson or Spearman correlations (depending on the distribution of the measures) or one measure is binary (i.e., cancer yes/no) then will examine 2-sample t-tests.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02252978


Locations
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United States, North Carolina
Veterans Administration Medical Center.
Salisbury, North Carolina, United States, 28144
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
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Principal Investigator: K. C. Balaji Wake Forest University Health Sciences

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02252978     History of Changes
Other Study ID Numbers: IRB00028209
NCI-2014-01594 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CCCWFU 99712 ( Other Identifier: Comprehensive Cancer Center of Wake Forest University )
P30CA012197 ( U.S. NIH Grant/Contract )
First Posted: September 30, 2014    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Genital Diseases, Male
Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors