Assessing infections after prostate biopsy without antibiotics
Infective Complications in Transperineal Prostate Biopsy Without Antibiotic Prophylaxis: A Prospective Cohort Study
This study tests whether men who have a prostate biopsy without antibiotics are more likely to get infections compared to those who had antibiotics before the procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1900 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Shatin) |
| Trial ID | NCT06359964 on ClinicalTrials.gov |
What this trial studies
This study investigates the incidence of infective complications following transperineal prostate biopsy performed without antibiotic prophylaxis. It involves recruiting consecutive patients undergoing the biopsy at Prince of Wales Hospital, where they will not receive antibiotics prior to the procedure. The study will compare outcomes with historical data from patients who received antibiotic prophylaxis, utilizing propensity score matching to ensure balanced baseline characteristics. Follow-up data will be collected to assess any infective complications that arise post-biopsy.
Who should consider this trial
Good fit: Ideal candidates include men undergoing transperineal prostate biopsy for various indications such as elevated PSA levels or abnormal digital rectal exams.
Not a fit: Patients with recent urinary tract infections, recurrent UTIs, or those who are immunocompromised may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the safety of performing prostate biopsies without antibiotic prophylaxis, potentially reducing unnecessary antibiotic use.
How similar studies have performed: While there is existing data on antibiotic prophylaxis in prostate biopsies, this specific approach of comparing outcomes without prophylaxis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shatin
- Prince of Wales Hospital — Shatin, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Peter Ka-Fung CHIU, PhD — Chinese University of Hong Kong
- Study coordinator: Peter Ka-Fung CHIU, PhD
- Email: peterchiu@surgery.cuhk.edu.hk
- Phone: 35052625
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.