Transperineal MRI-TRUS Fusion Guided Prostate Biopsy With vs Without Antibiotic Prophylaxis (NORAPP)

A Prospective Randomized Trial of Antibiotic Prophylaxis Versus None Before Transperineal MRI-TRUS Fusion Guided Prostate Biopsy

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.

Study Overview

• Status: Completed
• Conditions: Prostate Biopsy; Antibiotic
• Intervention / Treatment: Procedure: Transperineal prostate biopsy with or without antibiotic prophylaxis

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.

• Study Type: Interventional
• Enrollment (Actual): 550
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Vivantes Klinikum Am Urban
• Norway
  • Oslo, Norway, 0514
    • Oslo University Hospital, Aker

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Transperineal prostate biopsy with antibiotic profylaxis; Cefuroxim 1.5 g will be applied intramuscularly before prostate biopsy	Procedure: Transperineal prostate biopsy with or without antibiotic prophylaxis; As described above.
Experimental: Transperineal prostate biopsy without antibiotic profylaxis; No antibiotics will be used before or after prostate biopsy	Procedure: Transperineal prostate biopsy with or without antibiotic prophylaxis; As described above.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of sepsis	Post biopsy sepsis will be defined by SIRS criteria	Up to 30 days
Incidence of post biopsy urinary tract infection	Post biopsy urinary tract infection not demanding hospital admission within 30	Up to 30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain during the local anesthesia application	Patients will be asked to mention the intensity of pain during the anesthesia using Visual Analog Score for pain, range: 0 to 10, the worse is 10.	Immediately after the intervention
Pain during the prostate biopsy	Patients will be asked to mention the intensity of pain during the prostate biopsy using Visual Analog Score for pain, range: 0 to 10, the worse is 10.	Immediately after the intervention

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University of Oslo
• Investigators: Principal Investigator: Eduard Baco, MD, PhD, Oslo University Hospital, Oslo, Norway; Study Chair: Erik Rud, MD,PhD, Oslo University Hospital, Oslo, Norway; Study Chair: Karsten Gunzel, MD, Vivantes Klinkum Am Urban, Berlin, Germany

Publications and helpful links

General Publications

• Jacewicz M, Günzel K, Rud E, Sandbæk 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2019
• Primary Completion (Actual): February 28, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: October 28, 2019
• First Submitted That Met QC Criteria: October 29, 2019
• First Posted (Actual): October 31, 2019

Study Record Updates

• Last Update Posted (Actual): December 7, 2021
• Last Update Submitted That Met QC Criteria: December 4, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Prostate Cancer; Biopsy; Randomization; Complication
• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 2019/1266

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: All data generated during this study will be evaluated at Oslo University Hospital

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No