Transperineal Versus Transrectal Prostate Biopsy

Sponsor
Maastricht University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT06027203
Collaborator
(none)
923
1
3.1
298.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: prostate biopsy

Study Design

Study Type:
Observational
Actual Enrollment :
923 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Freehand Transperineal Prostate Biopsies Without Antibiotic Prophylaxis - the New Gold Standard?
Actual Study Start Date :
Apr 15, 2023
Actual Primary Completion Date :
Jun 15, 2023
Actual Study Completion Date :
Jul 18, 2023

Arms and Interventions

Arm Intervention/Treatment
transrectal biopsy

Procedure: prostate biopsy
Prostate biopsy by either transrectal or transperineal technique

transperineal biopsy

Procedure: prostate biopsy
Prostate biopsy by either transrectal or transperineal technique

Outcome Measures

Primary Outcome Measures

  1. Complications [2 weeks]

    Urinary tract infections, urinary retention, hematuria

Secondary Outcome Measures

  1. Detection rate [2 weeks]

    Chance of detecting prostate cancer according to histopathology of needle biopsy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Maastricht University Medical Center Maastricht Netherlands 6229HX

Sponsors and Collaborators

  • Maastricht University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT06027203
Other Study ID Numbers:
  • MUMC-Pbx23
First Posted:
Sep 7, 2023
Last Update Posted:
Sep 7, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Maastricht University Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 7, 2023