NCT06359964

Infective Complications in TP Biopsy Without Antibiotic Prophylaxis

Infective Complications in Transperineal Prostate Biopsy Without Antibiotic Prophylaxis: A Prospective Cohort Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,900 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective cohort study to delineate the infective outcomes and incidence after transperineal prostate biopsy with no antibiotic prophylaxis, compared to the existing data on outcomes on patients receiving transperineal prostate biopsy with antibiotic prophylaxis.

Detailed description

All consecutive patients receiving transperineal prostate biopsy in the PWH will be recruited to the exposure cohort after informed consent. Antibiotic prophylaxis will not be given for patients in the exposure group. All patients will undergo transperineal prostate biopsy in the usual manner and technique, under the Ginsburg protocol. Systematic and MRI-TRUS fusion for systematic plus targeted biopsy will be performed based on the usual clinical indications, depending on the clinical need. Follow-up data will be collected, with particular interest on the assessment of infective complications. Prospectively collected data will also be retrieved from the electronic patient record (ePR) under the Hospital Authority, to assess relevant information on infective complications for patients who received transperineal prostate biopsy in PWH and NDH from 2019 to 2023. These patients received antibiotic prophylaxis prior to their biopsies, and eligible patients will be included as the control cohort for comparison. Propensity score matching will be utilized in order to create a control group that is similar to the exposure group with balanced baseline. Statistical analysis will be performed on the retrieve data.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	Transperineal Biopsy without antibiotics prophylaxis	Transperineal Biopsy without antibiotics prophylaxis
PROCEDURE	Transperineal Biopsy with antibiotics prophylaxis	Transperineal Biopsy with antibiotics prophylaxis

Timeline

• Start date: 2024-08-04
• Primary completion: 2026-12-31
• Completion: 2027-03-31
• First posted: 2024-04-11
• Last updated: 2024-11-22

Locations

1 site across 1 country: Hong Kong