Reduction of Prostate Biopsy Morbidity

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: Transperineal biopsy Protocol

Detailed Description

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)

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

Traditional biopsy protocol includes: (Controls)

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

• Study Type: Observational
• Enrollment (Actual): 157

Contacts and Locations

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11219
      • Maimonides Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Males with clinical indication for a prostate biopsy.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
transperineal protocol; 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.	Procedure: Transperineal biopsy Protocol; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of clinically significant post-biopsy complications	1. Rate of any clinically significant post-biopsy complications including infectious complications and hospital readmissions within 30 days.	30 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Number of individual complications within 30 days	1. Individual complications within 30 days including urinary retention, hematuria, urinary tract infection, hospitalization	30 Days

Collaborators and Investigators

• Sponsor: Maimonides Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: April 10, 2019
• First Submitted That Met QC Criteria: April 11, 2019
• First Posted (Actual): April 12, 2019

Study Record Updates

• Last Update Posted (Actual): February 10, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2019-03-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No