Reduction of Prostate Biopsy Morbidity

Completed

• Conditions: Prostate Cancer
• Interventions: Procedure: Transperineal biopsy Protocol

• Registration Number: NCT03913039
• Lead Sponsor: Maimonides Medical Center

Brief Summary

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.

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 Timeline

• Study First Submitted: 2019-04-10
• Study First Submitted QC: 2019-04-11
• Study First Posted: 2019-04-12
• Study Start: 2019-05-01
• Primary Completion: 2021-10-31
• Study Completion: 2021-12-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-08
• Last Update Posted: 2022-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 157

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
transperineal protocol	Transperineal biopsy Protocol	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.

Primary Outcome Measures

Name	Time	Method
Rate of clinically significant post-biopsy complications	30 Days	1. Rate of any clinically significant post-biopsy complications including infectious complications and hospital readmissions within 30 days.

Secondary Outcome Measures

Name	Time	Method
1. Number of individual complications within 30 days	30 Days	1. Individual complications within 30 days including urinary retention, hematuria, urinary tract infection, hospitalization

Trial Locations

Locations (1)

Maimonides Medical Center; 🇺🇸 Brooklyn, New York, United States