Clinical trial NCT06359964: Infective Complications in TP Biopsy Without Antibiotic Prophylaxis
Official title: Infective Complications in Transperineal Prostate Biopsy Without Antibiotic Prophylaxis: A Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 1900
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: The difference in UTI hospitalization rate between the two groups after biopsy
timeFrame: Within 14 days of biopsy
measure: The difference in urosepsis rates between the two groups after biopsy
timeFrame: Within 14 days of biopsy
Secondary outcomes:
measure: Post-biopsy UTI rates between the two groups
timeFrame: At post-biopsy Day 14
measure: Assessment of bacteriology and antibiotic resistant profile between the two groups
timeFrame: At post-biopsy Day 14
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Peter Ka-Fung CHIU, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Derin O, Fonseca L, Sanchez-Salas R, Roberts MJ. Infectious complications of prostate biopsy: winning battles but not war. World J Urol. 2020 Nov;38(11):2743-2753. doi: 10.1007/s00345-020-03112-3. Epub 2020 Feb 24.
citation: Li JKM, Wang LL, Lau BSY, Tse RTH, Cheng CKL, Leung SCH, Wong CYP, Tsui SKW, Teoh JYC, Chiu PKF, Ng CF. Oral antibiotics perturbation on gut microbiota after prostate biopsy. Front Cell Infect Microbiol. 2022 Aug 16;12:959903. doi: 10.3389/fcimb.2022.959903. eCollection 2022.
citation: Castellani D, Pirola GM, Law YXT, Gubbiotti M, Giulioni C, Scarcella S, Wroclawski ML, Chan E, Chiu PK, Teoh JY, Gauhar V, Rubilotta E. Infection Rate after Transperineal Prostate Biopsy with and without Prophylactic Antibiotics: Results from a Systematic Review and Meta-Analysis of Comparative Studies. J Urol. 2022 Jan;207(1):25-34. doi: 10.1097/JU.0000000000002251. Epub 2021 Sep 24.
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