Clinical trial · Interventional
Transperineal MRI-TRUS Fusion Guided Prostate Biopsy With vs Without Antibiotic Prophylaxis
A Prospective Randomized Trial of Antibiotic Prophylaxis Versus None Before Transperineal MRI-TRUS Fusion Guided Prostate Biopsy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prostate biopsy is indicated in patients with suspected prostate cancer and has been traditionally performed through the rectum using antibiotic prophylaxis. Increasing antibiotic resistance of intestinal bacteria is causing a growing number of patients to get post-biopsy infections. Sepsis rate after transrectal biopsies is approximately 4-10%. To reduce the risk of post-biopsy infections, transperineal approach in general anesthesia and antibiotic prophylaxis has been used. The investigators at Oslo University Hospital Aker developed MRI -TURS elastic image fusion guided transperineal prostate biopsy technique in local anesthesia and Bactrim prophylaxis as outpatient procedure. The investigators found 0.4% post-biopsy infection rate. Afterwards a pilot study using the same biopsy technique however without antibiotic prophylaxis was realized in 90 patients. None of these subjects experienced infection. The investigators wish to perform a prospective randomized trial of antibiotic prophylaxis versus none before transperineal MRI-TRUS fusion guided prostate biopsy in local anesthesia in outpatient clinic.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Antibiotic | — | UNRESOLVED | — |
| Prostate Biopsy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transperineal prostate biopsy with or without antibiotic prophylaxis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Transperineal prostate biopsy with antibiotic profylaxis
- description
- Cefuroxim 1.5 g will be applied intramuscularly before prostate biopsy
- interventionNames
- Procedure: Transperineal prostate biopsy with or without antibiotic prophylaxis
- type
- EXPERIMENTAL
- label
- Transperineal prostate biopsy without antibiotic profylaxis
- description
- No antibiotics will be used before or after prostate biopsy
- interventionNames
- Procedure: Transperineal prostate biopsy with or without antibiotic prophylaxis
Primary outcomes (2)
- measure
- Incidence of sepsis
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: Clinical indication for prostate cancer \- Exclusion Criteria: * Patients with symptoms of urinary tract infection or positive findings on urine dipstic before biopsy * Patients with indwelling urethral catheter * Patients with immunodeficiency disorders * Patients with high risk for infective endocarditis \[European Society of Cardiology\] 1. Patients with a prosthetic aortic or pulmonary valve 2. Patients with previous infective endocarditis 3. Patients with congenital heart disease who are cyanotic and those who have had palliative shunts/conduits/other prostheses * Patients with a history of thromboembolic disease * Patients with a history of allergy to the study drug * Patients who do not wish to participate in the study
References
Publications (2)
- DERIVEDJacewicz M, Rud E, Lauritzen P, Baco E. Non-infectious adverse events of transperineal prostate biopsies performed under local anaesthesia. BJU Int. 2024 Aug;134(2):300-306. doi: 10.1111/bju.16383. Epub 2024 Apr 28. PMID 38679416
- DERIVEDJacewicz M, Gunzel K, Rud E, Sandbaek G, Magheli A, Busch J, Hinz S, Baco E. Antibiotic prophylaxis versus no antibiotic prophylaxis in transperineal prostate biopsies (NORAPP): a randomised, open-label, non-inferiority trial. Lancet Infect Dis. 2022 Oct;22(10):1465-1471. doi: 10.1016/S1473-3099(22)00373-5. Epub 2022 Jul 12. PMID 35839791