Infective Complications in TP Biopsy Without Antibiotic Prophylaxis

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Procedure: Transperineal Biopsy without antibiotics prophylaxis; Procedure: Transperineal Biopsy with antibiotics prophylaxis

Study type: Interventional

Funder types: Other

Identifiers

NCT06359964

CRE2023.195

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,900 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,900 participants in 2 patient groups

TP BIospy without antibiotic prophylaxis

Experimental group

Description:

Transperineal Biopsy without antibiotic prophylaxis

Treatment:

Procedure: Transperineal Biopsy without antibiotics prophylaxis

TP BIospy with antibiotic prophylaxis

Active Comparator group

Description:

Transperineal Biopsy with antibiotic prophylaxis

Treatment:

Procedure: Transperineal Biopsy with antibiotics prophylaxis