Reduction of Prostate Biopsy Morbidity

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03913039
• Other study ID #: 2019-03-03
• Status: Completed
• Start date: May 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2022
• Source: Maimonides Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: December 31, 2021
• Est. primary completion date: October 31, 2021
• Gender: Male
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Maimonides Medical Center	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
Maimonides Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1. Number of individual complications within 30 days	1. Individual complications within 30 days including urinary retention, hematuria, urinary tract infection, hospitalization	30 Days