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Clinical Trials/NCT06027203
NCT06027203
Completed
Not Applicable

Freehand Transperineal Prostate Biopsies Without Antibiotic Prophylaxis - the New Gold Standard?

Maastricht University Medical Center1 site in 1 country923 target enrollmentApril 15, 2023
ConditionsProstate Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Maastricht University Medical Center
Enrollment
923
Locations
1
Primary Endpoint
Complications
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Background: Prostate biopsies are essential to diagnose prostate cancer (PCa). Transrectal prostate biopsies (TR-PB) are commonly performed, however disadvantages include the requirement of antibiotic prophylaxis (AP) and higher complication rates than transperineal prostate biopsies (TP-PB). Guidelines still recommend the use of AP for TP-PB due to the limited evidence regarding complication rates after their omission. However, the rising rates of antibiotic resistance is of concern. The aim of this study was to compare the complication and detection rates of freehand TP-PB without AP versus TR-PB with AP.

Methods: This single center retrospective study was performed in an academic hospital. TP-PB were introduced in 2019 and implemented as the main technique by late 2020. To compare the two techniques, data was collected for freehand TR-PB with AP between 2017-2018 and freehand TP-PB without AP between 2021-2022. The data from 2019 and 2020 were excluded to rule out the effects of the initial learning curve during the transition period. Primary outcome measure was post-biopsy complications occurring within 2 weeks, focusing on infectious complications. Secondary outcome measures were detection rates and upgrading/reclassification in the repeat biopsy in active surveillance (AS). Statistical analysis was performed using a Fisher exact or Chi-Squared test.

Registry
clinicaltrials.gov
Start Date
April 15, 2023
End Date
July 18, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • men who underwent prostate biopsy between 2017-2018 (transrectal)
  • men who underwent prostate biopsy between 2012-2022 (transperineal)

Exclusion Criteria

  • positive urine culture before biopsy
  • patients in the transrectal biopsy group who did not take the prescribed course of antibiotic prophylaxis
  • incomplete medical dossier where the occurrence of a complication could not be assessed

Outcomes

Primary Outcomes

Complications

Time Frame: 2 weeks

Urinary tract infections, urinary retention, hematuria

Secondary Outcomes

  • Detection rate(2 weeks)

Study Sites (1)

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