Reduction of Prostate Biopsy Morbidity

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    154
  • sponsor
    Maimonides Medical Center
Updated on 14 May 2021
biopsy of prostate

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.

Details
Condition Malignant neoplasm of prostate, Prostatic disorder, Prostate Disorders, Prostate Cancer, Early, Recurrent, Prostate Cancer, prostate carcinoma, prostate cancers
Treatment Transperineal biopsy Protocol
Clinical Study IdentifierNCT03913039
SponsorMaimonides Medical Center
Last Modified on14 May 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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