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Completed

NCT Number: NCT06359964

Infective Complications in TP Biopsy Without Antibiotic Prophylaxis

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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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital

Shatin, Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transperineal Biopsy without antibiotics prophylaxis

Procedure

Transperineal Biopsy without antibiotics prophylaxis

Transperineal Biopsy with antibiotics prophylaxis

Procedure

Transperineal Biopsy with antibiotics prophylaxis

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 11, 2024
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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