Transperineal Versus Transrectal Prostate Biopsy

NCT ID: NCT06027203

Last Updated: 2023-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

923 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-15

Study Completion Date

2023-07-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

transrectal biopsy

prostate biopsy

Intervention Type PROCEDURE

Prostate biopsy by either transrectal or transperineal technique

transperineal biopsy

prostate biopsy

Intervention Type PROCEDURE

Prostate biopsy by either transrectal or transperineal technique

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

prostate biopsy

Prostate biopsy by either transrectal or transperineal technique

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Maastricht University Medical Center

Maastricht, , Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MUMC-Pbx23

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Ga-68-PSMA-11 in High-risk Prostate Cancer
NCT03362359 COMPLETED PHASE1/PHASE2