Reduction of Prostate Biopsy Morbidity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

157 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-01

Study Completion Date

2021-12-31

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.

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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)

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.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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transperineal 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.

Transperineal biopsy Protocol

Intervention Type PROCEDURE

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

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.

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE