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NCT Number: NCT04146142

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

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.

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Key information

Conditions

Prostate Biopsy Antibiotic Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Vivantes Klinikum am Urban, Berlin, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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]
  • Patients with a prosthetic aortic or pulmonary valve
  • Patients with previous infective endocarditis
  • 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

Treatment and study plan

Transperineal prostate biopsy with or without antibiotic prophylaxis

Procedure

As described above.

Primary outcomes

  1. Incidence of sepsis

    Time frame: Up to 30 days

    Post biopsy sepsis will be defined by SIRS criteria

  2. Incidence of post biopsy urinary tract infection

    Time frame: Up to 30 days

    Post biopsy urinary tract infection not demanding hospital admission within 30

Other outcomes

  1. Pain during the local anesthesia application

    Time frame: Immediately after the intervention

    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.

  2. Pain during the prostate biopsy

    Time frame: Immediately after the intervention

    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.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • University of Oslo

Registry information

Official study title

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

Acronym: NORAPP

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 31, 2019
Registry last updated
Dec 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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