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

Prostate Biopsy Clinical Trial

— NORAPP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04146142
• Other study ID #: 2019/1266
• Status: Completed
• Phase: N/A
• Start date: November 11, 2019
• Est. completion date: April 30, 2021

Study information

• Verified date: December 2021
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: April 30, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic
• Prostate Biopsy

Intervention

Procedure:
• Transperineal prostate biopsy with or without antibiotic prophylaxis
As described above.

Locations

Country	Name	City	State
Germany	Vivantes Klinikum am Urban	Berlin
Norway	Oslo University Hospital, Aker	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	University of Oslo

Countries where clinical trial is conducted

Germany,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	Incidence of sepsis	Post biopsy sepsis will be defined by SIRS criteria	Up to 30 days
Primary	Incidence of post biopsy urinary tract infection	Post biopsy urinary tract infection not demanding hospital admission within 30	Up to 30 days