Infective Complications in TP Biopsy Without Antibiotic Prophylaxis

Trial Title: Infective Complications in TP Biopsy Without Antibiotic Prophylaxis

NCT ID: NCT06359964

Condition: Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms
Anti-Bacterial Agents
Antibiotics, Antitubercular

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Transperineal Biopsy without antibiotics prophylaxis
Description: Transperineal Biopsy without antibiotics prophylaxis
Arm group label: TP BIospy without antibiotic prophylaxis

Intervention type: Procedure
Intervention name: Transperineal Biopsy with antibiotics prophylaxis
Description: Transperineal Biopsy with antibiotics prophylaxis
Arm group label: TP BIospy with antibiotic prophylaxis

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.

Criteria for 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

Gender: Male

Gender based: Yes

Gender description: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: April 1, 2024

Completion date: March 31, 2027

Lead sponsor:
Agency: Chinese University of Hong Kong
Agency class: Other

Source: Chinese University of Hong Kong

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06359964