Prostate Cancer
Conditions
Brief summary
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.
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.
Interventions
PROCEDURETransperineal Biopsy without antibiotics prophylaxis
Transperineal Biopsy without antibiotics prophylaxis
PROCEDURETransperineal Biopsy with antibiotics prophylaxis
Transperineal Biopsy with antibiotics prophylaxis
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The difference in UTI hospitalization rate between the two groups after biopsy | Within 14 days of biopsy | UTI hospitalization rate is defined symptomology requiring admission to an in-patient facility |
| The difference in urosepsis rates between the two groups after biopsy | Within 14 days of biopsy | Urosepsis is defined as sepsis of likely urological source either based on symptomology or bacteriology. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-biopsy UTI rates between the two groups | At post-biopsy Day 14 | The result of clean catch mid-stream urine for culture |
| Assessment of bacteriology and antibiotic resistant profile between the two groups | At post-biopsy Day 14 | The bacteriology and antibiotic resistant profile are assessed by clean-catch urine culture. |
Countries
Hong Kong
Contacts
PRINCIPAL_INVESTIGATORPeter Ka-Fung CHIU, PhD
Chinese University of Hong Kong
Outcome results
None listed