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Reduction of Prostate Biopsy Morbidity

NCT03913039 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 157

Last updated 2022-02-10

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Transperineal 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 & Collaborators

  • Maimonides Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2021-10-31
Completion
2021-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03913039 on ClinicalTrials.gov