Reduction of Prostate Biopsy Morbidity

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: Transperineal biopsy Protocol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Male

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| transperineal protocol<br>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<br>* 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.<br>|
| Traditional biopsy<br>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?
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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 |