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

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ClinicalTrials.gov Identifier: NCT04146142
Recruitment Status : Completed
First Posted : October 31, 2019
Last Update Posted : May 24, 2021
Sponsor:
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Eduard Baco, Oslo University Hospital

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.


Condition or disease Intervention/treatment Phase
Prostate Biopsy Antibiotic Procedure: Transperineal prostate biopsy with or without antibiotic prophylaxis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized study 1:1
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial of Antibiotic Prophylaxis Versus None Before Transperineal MRI-TRUS Fusion Guided Prostate Biopsy
Actual Study Start Date : October 24, 2019
Actual Primary Completion Date : February 28, 2021
Actual Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Biopsy

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.




Primary Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04146142


Locations
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Germany
Vivantes Klinikum am Urban
Berlin, Germany
Norway
Oslo University Hospital, Aker
Oslo, Norway, 0514
Sponsors and Collaborators
Oslo University Hospital
University of Oslo
Investigators
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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
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Responsible Party: Eduard Baco, Principal investigator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04146142    
Other Study ID Numbers: 2019/1266
First Posted: October 31, 2019    Key Record Dates
Last Update Posted: May 24, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data generated during this study will be evaluated at Oslo University Hospital

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eduard Baco, Oslo University Hospital:
Prostate Cancer
Biopsy
Complication
Randomization
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Anti-Infective Agents