Reduction of Prostate Biopsy Morbidity
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|ClinicalTrials.gov Identifier: NCT03913039|
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : April 12, 2019
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Procedure: Transperineal biopsy Protocol|
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.
|Study Type :||Observational|
|Estimated Enrollment :||154 participants|
|Official Title:||Reduction of Prostate Biopsy Morbidity and Hospitalization Through a Modified Biopsy Protocol Bundle and Region-specific Antibiogram|
|Estimated Study Start Date :||April 15, 2019|
|Estimated Primary Completion Date :||April 15, 2021|
|Estimated Study Completion Date :||May 31, 2021|
Procedure: Transperineal biopsy Protocol
- Rate of clinically significant post-biopsy complications [ Time Frame: 30 Days ]1. Rate of any clinically significant post-biopsy complications including infectious complications and hospital readmissions within 30 days.
- 1. Number of individual complications within 30 days [ Time Frame: 30 Days ]1. Individual complications within 30 days including urinary retention, hematuria, urinary tract infection, hospitalization
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913039
|Contact: Ariel Schulman, MD||7182836903||ASchulman@maimonidesmed.org|
|Contact: Sara Meederfirstname.lastname@example.org|
|United States, New York|
|Maimonides Medical Center||Recruiting|
|Brooklyn, New York, United States, 11219|
|Contact: Ariel Schulman, MD|