Prostate Cancer Clinical Trial
Reduction of Prostate Biopsy Morbidity
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.
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
Urine culture, prostate tissue culture and rectal swab culture to define contemporary, region-specific antibiotic resistance patterns.
Traditional biopsy protocol includes: (Controls)
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.
Male patients greater than 18 years of age
Indication for prostate biopsy
Male patients under 18 years of age
No indication for prostate biopsy
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There is 1 Location for this study
Brooklyn New York, 11219, United States
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