Skip to main content
OpenTrials
Completed

NCT Number: NCT06027203

Transperineal Versus Transrectal Prostate Biopsy

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Maastricht University Medical Center

Maastricht, 6229HX, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prostate biopsy

Procedure

Prostate biopsy by either transrectal or transperineal technique

Primary outcomes

  1. Complications

    Time frame: 2 weeks

    Urinary tract infections, urinary retention, hematuria

Secondary outcomes

  1. Detection rate

    Time frame: 2 weeks

    Chance of detecting prostate cancer according to histopathology of needle biopsy

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 7, 2023
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.