Reduction of Prostate Biopsy Morbidity
1 other identifier
observational
157
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2019
CompletedFirst Posted
Study publicly available on registry
April 12, 2019
CompletedStudy Start
First participant enrolled
May 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedFebruary 10, 2022
February 1, 2022
2.5 years
April 10, 2019
February 8, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
1. Number of individual complications within 30 days
30 Days
Study Arms (2)
transperineal 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.
Traditional biopsy
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.
Interventions
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.
Eligibility Criteria
Males with clinical indication for a prostate biopsy.
You may qualify if:
- Male patients greater than 18 years of age
- Indication for prostate biopsy
You may not qualify if:
- Female patients
- Male patients under 18 years of age
- No indication for prostate biopsy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maimonides Medical Center
Brooklyn, New York, 11219, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 10, 2019
First Posted
April 12, 2019
Study Start
May 1, 2019
Primary Completion
October 31, 2021
Study Completion
December 31, 2021
Last Updated
February 10, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share