Transperineal Versus Transrectal Prostate Biopsy

NCT06027203 | Completed

• 1 other identifier: MUMC-Pbx23
• Study Type: observational
• Target: 923
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

prostate biopsy; prostate cancer; transperineal; transrectal

Outcome Measures

Primary Outcomes (1)

• Complications

  Urinary tract infections, urinary retention, hematuria

  2 weeks

Secondary Outcomes (1)

• Detection rate

  2 weeks

Study Arms (2)

transrectal biopsy

Procedure: prostate biopsy

transperineal biopsy

Procedure: prostate biopsy

Interventions

prostate biopsy PROCEDURE

Prostate biopsy by either transrectal or transperineal technique

transperineal biopsy; transrectal biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All men who underwent a transrectal prostate biopsy between January 2017 and December 2018, and/or a transperineal prostate biopsy between January 2021 and December 2022 in the Urology department of MUMC+

You may qualify if:

• men who underwent prostate biopsy between 2017-2018 (transrectal)
• men who underwent prostate biopsy between 2012-2022 (transperineal)

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, 6229HX, Netherlands

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: September 7, 2023
• Study Start: April 15, 2023
• Primary Completion: June 15, 2023
• Study Completion: July 18, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-09

Locations

NL (1)