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Transperineal Versus Transrectal Prostate Biopsy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06027203
Enrollment
923
Registered
2023-09-07
Start date
2023-04-15
Completion date
2023-07-18
Last updated
2023-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

prostate biopsy, prostate cancer, transperineal, transrectal

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.

Interventions

PROCEDUREprostate biopsy

Prostate biopsy by either transrectal or transperineal technique

Sponsors

Maastricht University Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Complications2 weeksUrinary tract infections, urinary retention, hematuria

Secondary

MeasureTime frameDescription
Detection rate2 weeksChance of detecting prostate cancer according to histopathology of needle biopsy

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026