Infective Complications in TP Biopsy Without Antibiotic Prophylaxis

April 8, 2024 updated by: CHIU Ka Fung Peter, Chinese University of Hong Kong

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

1900

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TP BIospy without antibiotic prophylaxis
Transperineal Biopsy without antibiotic prophylaxis
Procedure: Transperineal Biopsy without antibiotics prophylaxis
Transperineal Biopsy without antibiotics prophylaxis
Active Comparator: TP BIospy with antibiotic prophylaxis
Transperineal Biopsy with antibiotic prophylaxis
Procedure: Transperineal Biopsy with antibiotics prophylaxis
Transperineal Biopsy with antibiotics prophylaxis

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Peter Ka-Fung CHIU, PhD, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

March 5, 2024

First Submitted That Met QC Criteria

April 8, 2024

First Posted (Actual)

April 11, 2024

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE2023.195

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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