Transperineal Versus Transrectal Prostate Biopsy

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06027203
• Other study ID #: MUMC-Pbx23
• Status: Completed
• Start date: April 15, 2023
• Est. completion date: July 18, 2023

Study information

• Verified date: September 2023
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 923
• Est. completion date: July 18, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications	Urinary tract infections, urinary retention, hematuria	2 weeks
Secondary	Detection rate	Chance of detecting prostate cancer according to histopathology of needle biopsy	2 weeks