Clinical trial NCT04146142: Transperineal MRI-TRUS Fusion Guided Prostate Biopsy With vs Without Antibiotic Prophylaxis
Official title: A Prospective Randomized Trial of Antibiotic Prophylaxis Versus None Before Transperineal MRI-TRUS Fusion Guided Prostate Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Biopsy
Antibiotic
Keywords: Prostate Cancer
Biopsy
Complication
Randomization
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2019-10-31
Enrollment: 550
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized study 1:1
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Background: Unnecessary use of antibiotics promotes antibiotic resistance. Efforts for antibiotic use reduction without increase the risk of serious infection complications are therefore needed.

Purpose: The aim of this trial is to compare the rates of infectious complication after transperineal prostate biopsy in patients with and without antibiotic prophylaxis.

Materials and methods: A total of 450 patients will be included in this trial. A 1:1 randomization to receive or not receive antibiotics prophylaxis will be performed using randomization system WebCRF-3 system. MRI-TRUS fusion prostate biopsy will be done with transperineal prostate approach in local anesthesia in outpatient clinic. In patients with normal MRI,12-core systematic prostate biopsies with 3D biopsy registration will be done according to the EAU guidelines. In patients with positive MRI, 2-4 targeted biopsies from the suspicious MRI areas will be realized and systematic prostate biopsies will also be done. All prostate biopsies will be performed using Koelis MRI-TRUS image fusion and organ based tracking system. Post-biopsy infection and any adverse events will be systematically prospectively registered in all patients. Pain during the local anesthesia application and during the biopsy procedure will be registered using Visual Analog Score, 10 points scale questionnaire.

Eligibility criteria: Inclusion Criteria: Clinical indication for prostate cancer

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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

Primary outcomes:
measure: Incidence of sepsis
timeFrame: Up to 30 days
measure: Incidence of post biopsy urinary tract infection
timeFrame: Up to 30 days
Secondary outcomes:
Other outcomes:
measure: Pain during the local anesthesia application
timeFrame: Immediately after the intervention
measure: Pain during the prostate biopsy
timeFrame: Immediately after the intervention
Locations:
city: Berlin
country: Germany
facility: Vivantes Klinikum am Urban
city: Oslo
country: Norway
facility: Oslo University Hospital, Aker
Study officials:
affiliation: Oslo University Hospital, Oslo, Norway
name: Eduard Baco, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital, Oslo, Norway
name: Erik Rud, MD,PhD
role: STUDY_CHAIR
affiliation: Vivantes Klinkum Am Urban, Berlin, Germany
name: Karsten Gunzel, MD
role: STUDY_CHAIR
References:
citation: Jacewicz 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.