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

NCT ID: NCT04146142

Last Updated: 2021-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 550 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-11
• Study Completion Date: 2021-04-30

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.

Conditions

Prostate Biopsy; Antibiotic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transperineal prostate biopsy with antibiotic profylaxis

Cefuroxim 1.5 g will be applied intramuscularly before prostate biopsy

Group Type: ACTIVE_COMPARATOR

Transperineal prostate biopsy with or without antibiotic prophylaxis

Intervention Type: PROCEDURE

As described above.

Transperineal prostate biopsy without antibiotic profylaxis

No antibiotics will be used before or after prostate biopsy

Group Type: EXPERIMENTAL

Transperineal prostate biopsy with or without antibiotic prophylaxis

Intervention Type: PROCEDURE

As described above.

Interventions

Transperineal prostate biopsy with or without antibiotic prophylaxis

As described above.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

-

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

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Oslo

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Eduard Baco

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eduard Baco, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital, Oslo, Norway

Erik Rud, MD,PhD

Role: STUDY_CHAIR

Oslo University Hospital, Oslo, Norway

Karsten Gunzel, MD

Role: STUDY_CHAIR

Vivantes Klinkum Am Urban, Berlin, Germany

Locations

Vivantes Klinikum am Urban

Berlin, , Germany

Oslo University Hospital, Aker

Oslo, , Norway

Countries

Germany; Norway

References

Jacewicz M, Rud E, Lauritzen P, Baco E. Non-infectious adverse events of transperineal prostate biopsies performed under local anaesthesia. BJU Int. 2024 Aug;134(2):300-306. doi: 10.1111/bju.16383. Epub 2024 Apr 28.

Reference Type: DERIVED

PMID: 38679416 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35839791 (View on PubMed)

Other Identifiers

2019/1266

Identifier Type: -

Identifier Source: org_study_id