Infective Complications in TP Biopsy Without Antibiotic Prophylaxis

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-04

Study Completion Date

2027-03-31

Brief Summary

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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.

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Detailed Description

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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

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Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TP BIospy without antibiotic prophylaxis

Transperineal Biopsy without antibiotic prophylaxis

Group Type EXPERIMENTAL

Transperineal Biopsy without antibiotics prophylaxis

Intervention Type PROCEDURE

Transperineal Biopsy without antibiotics prophylaxis

TP BIospy with antibiotic prophylaxis

Transperineal Biopsy with antibiotic prophylaxis

Group Type ACTIVE_COMPARATOR

Transperineal Biopsy with antibiotics prophylaxis

Intervention Type PROCEDURE

Transperineal Biopsy with antibiotics prophylaxis

Interventions

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Transperineal Biopsy without antibiotics prophylaxis

Intervention Type PROCEDURE

Transperineal Biopsy with antibiotics prophylaxis

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No