NCT02252978

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 30, 2014

Completed
1.8 years until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 5, 2018

Status Verified

July 1, 2018

Enrollment Period

Same day

First QC Date

July 31, 2014

Last Update Submit

July 3, 2018

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Prostate cancer detection rates

    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.

    Up to 8 weeks

Secondary Outcomes (2)

  • Change in PSA

    Up to 8 weeks

  • Rates of post-biopsy complications (including duration of hematuria, hematochezia, hematospermia, fever > 101°F, and hospital admission rates related to biopsy, sepsis, and pain)

    Up to 8 weeks

Other Outcomes (6)

  • BPH or erectile dysfunction

    Up to 8 weeks

  • Change in urinalysis pre- and post-treatment

    Up to 8 weeks

  • Change in prostate massage outcomes

    Up to 8 weeks

  • +3 more other outcomes

Study Arms (2)

Arm I (ciprofloxacin)

EXPERIMENTAL

Patients receive ciprofloxacin PO BID for 2 weeks.

Drug: ciprofloxacinOther: quality-of-life assessmentOther: laboratory biomarker analysis

Arm II (placebo)

PLACEBO COMPARATOR

Patients receive placebo PO BID for 2 weeks.

Other: placeboOther: quality-of-life assessmentOther: laboratory biomarker analysis

Interventions

ciprofloxacinDRUG

Given PO

Also known as: Cipro, CPFX
Arm I (ciprofloxacin)
placeboOTHER

Given PO

Also known as: PLCB
Arm II (placebo)
quality-of-life assessmentOTHER

Ancillary studies

Also known as: quality of life assessment
Arm I (ciprofloxacin)Arm II (placebo)
laboratory biomarker analysisOTHER

Correlative studies

Arm I (ciprofloxacin)Arm II (placebo)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Veterans Administration Medical Center.

Salisbury, North Carolina, 28144, United States

Location

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Ciprofloxacin

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • K. C. Balaji

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2014

First Posted

September 30, 2014

Study Start

July 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

July 5, 2018

Record last verified: 2018-07

Locations

US(2)