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OpenTrials
Completed

NCT Number: NCT03913039

Reduction of Prostate Biopsy Morbidity

Prostate biopsy is typically performed via either the transrectal or transperineal approach. This study is a case-control study being done to determine if a novel prostate biopsy protocol incorporating a transperineal approach, rectal swab to detect resistant bacteria and broad antibiotic prophylaxis will reduce infectious complications and hospital readmission compared to current biopsy practices.

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Key information

Age range

18 year–120 year

Sex eligibility

Male

Study type

Observational

Primary location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

About this study

This will be a prospective multi-center cohort case-control study comparing a novel transperineal prostate biopsy protocol integrating measures to reduce post procedural infection (Cases) to traditional transrectal prostate biopsies (Controls). Eligible subjects will be identified through administrative records in the Urology clinics affiliated with Maimonides Medical Center. Eligible patients will be counseled about the risks and benefits of participation and offered enrollment into the study. Demographic data including age, comorbidities and past medical history will be extracted from the medical record.

Men meeting inclusion/exclusion criteria will be prospectively enrolled. The novel transperineal protocol will include the following: (Cases)

  • Transperineal biopsy approach with avoidance of rectal flora
  • MRI-ultrasound fusion-guided biopsies with reduced number of biopsy cores, where clinically indicated
  • Rectal swab to identify the presence of fluoroquinolone resistant (FQR) bacteria
  • Multi-antibiotic prophylaxis
  • Urine culture, prostate tissue culture and rectal swab culture to define contemporary, region-specific antibiotic resistance patterns.

Traditional biopsy protocol includes: (Controls)

  • Transrectal approach
  • Standard 12-core template
  • Surgeon-specific antibiotic prophylaxis
  • Urine culture, prostate tissue culture and FQR rectal swab culture to define contemporary, region-specific antibiotic resistance patterns.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male patients greater than 18 years of age
  • Indication for prostate biopsy

Exclusion criteria

  • Female patients
  • Male patients under 18 years of age
  • No indication for prostate biopsy

Treatment and study plan

Transperineal biopsy Protocol

Procedure
  • Transperineal biopsy approach with avoidance of rectal flora
  • MRI-ultrasound fusion-guided biopsies with reduced number of biopsy cores, where clinically indicated
  • Rectal swab to identify the presence of fluoroquinolone resistant (FQR) bacteria
  • Multi-antibiotic prophylaxis
  • Urine culture, prostate tissue culture and rectal swab culture to define contemporary, region-specific antibiotic resistance patterns.

Primary outcomes

  1. Rate of clinically significant post-biopsy complications

    Time frame: 30 Days

    • Rate of any clinically significant post-biopsy complications including infectious complications and hospital readmissions within 30 days.

Secondary outcomes

  1. 1. Number of individual complications within 30 days

    Time frame: 30 Days

    • Individual complications within 30 days including urinary retention, hematuria, urinary tract infection, hospitalization

Sponsors and collaborators

Lead sponsor

Maimonides Medical Center

Other

Registry information

Official study title

Reduction of Prostate Biopsy Morbidity and Hospitalization Through a Modified Biopsy Protocol Bundle and Region-specific Antibiogram

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 12, 2019
Registry last updated
Feb 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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