Infective Complications in TP Biopsy Without Antibiotic Prophylaxis

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Procedure: Transperineal Biopsy with antibiotics prophylaxis; Procedure: Transperineal Biopsy without antibiotics prophylaxis

• Registration Number: NCT06359964
• Lead Sponsor: Chinese University of Hong Kong

Brief 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.

Study Timeline

• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-04-08
• Study First Posted: 2024-04-11
• Study Start: 2024-08-04
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22
• Primary Completion: 2026-12-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 1900

Inclusion Criteria

• All consecutive patients in participating centres receiving transperineal USG-guided biopsy for any indication including:
• Elevated PSA
• Abnormal DRE
• Follow-up biopsy in active surveillance
• Suspicion of CAP recurrence after radiotherapy
• Follow-up biopsy after focal therapy
• Consenting to the study

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Exclusion Criteria

• Recent suspected UTI within 1 month
• Recent culture proven bacteriuria within 1 month
• History of recurrent UTI
• Indwelling urinary catheter
• Immunocompromised state
• High risk of infective endocarditis (including prosthetic heart valve, congenital heart disease, or previous history of infective endocarditis
• Incompetent or incapable of understanding the nature of the study or giving informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TP BIospy with antibiotic prophylaxis	Transperineal Biopsy with antibiotics prophylaxis	Transperineal Biopsy with antibiotic prophylaxis
TP BIospy without antibiotic prophylaxis	Transperineal Biopsy without antibiotics prophylaxis	Transperineal Biopsy without antibiotic prophylaxis

Primary Outcome Measures

Name	Time	Method
The difference in UTI hospitalization rate between the two groups after biopsy	Within 14 days of biopsy	UTI hospitalization rate is defined symptomology requiring admission to an in-patient facility
The difference in urosepsis rates between the two groups after biopsy	Within 14 days of biopsy	Urosepsis is defined as sepsis of likely urological source either based on symptomology or bacteriology.

Secondary Outcome Measures

Name	Time	Method
Post-biopsy UTI rates between the two groups	At post-biopsy Day 14	The result of clean catch mid-stream urine for culture
Assessment of bacteriology and antibiotic resistant profile between the two groups	At post-biopsy Day 14	The bacteriology and antibiotic resistant profile are assessed by clean-catch urine culture.

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong