Transperineal Versus Transrectal Prostate Biopsy

Completed

• Conditions: Prostate Cancer
• Interventions: Procedure: prostate biopsy

• Registration Number: NCT06027203
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-15
• Primary Completion: 2023-06-15
• Study Completion: 2023-07-18
• Study First Submitted: 2023-07-18
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-05
• Last Update Submitted: 2023-09-05
• Study First Posted: 2023-09-07
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 923

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
transperineal biopsy	prostate biopsy	-
transrectal biopsy	prostate biopsy	-

Primary Outcome Measures

Name	Time	Method
Complications	2 weeks	Urinary tract infections, urinary retention, hematuria

Secondary Outcome Measures

Name	Time	Method
Detection rate	2 weeks	Chance of detecting prostate cancer according to histopathology of needle biopsy

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands