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Reduction of Prostate Biopsy Morbidity

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03913039
Enrollment
157
Registered
2019-04-12
Start date
2019-05-01
Completion date
2021-12-31
Last updated
2022-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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.

Interventions

PROCEDURETransperineal 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.

Sponsors

Maimonides Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 120 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of clinically significant post-biopsy complications30 Days1\. Rate of any clinically significant post-biopsy complications including infectious complications and hospital readmissions within 30 days.

Secondary

MeasureTime frameDescription
1. Number of individual complications within 30 days30 Days1\. Individual complications within 30 days including urinary retention, hematuria, urinary tract infection, hospitalization

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026