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

NCT04146142 | Completed

• 1 other identifier: 2019/1266
• Study Type: interventional
• Target: 550
• Locations: 2 countries
• Sites: 2

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.

Conditions

Prostate Biopsy; Antibiotic

Keywords

Prostate Cancer; Biopsy; Complication; Randomization

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Pain during the local anesthesia application

  Immediately after the intervention

• Pain during the prostate biopsy

  Immediately after the intervention

Study Arms (2)

Transperineal prostate biopsy with antibiotic profylaxis

ACTIVE COMPARATOR

Cefuroxim 1.5 g will be applied intramuscularly before prostate biopsy

Procedure: Transperineal prostate biopsy with or without antibiotic prophylaxis

Transperineal prostate biopsy without antibiotic profylaxis

EXPERIMENTAL

No antibiotics will be used before or after prostate biopsy

Procedure: Transperineal prostate biopsy with or without antibiotic prophylaxis

Interventions

Transperineal prostate biopsy with or without antibiotic prophylaxis PROCEDURE

As described above.

Transperineal prostate biopsy with antibiotic profylaxis; Transperineal prostate biopsy without antibiotic profylaxis

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Oslo: collaborator

Study Sites (2)

Vivantes Klinikum am Urban

Berlin, Germany

Location

Oslo University Hospital, Aker

Oslo, 0514, Norway

Location

Related Publications (2)

• 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.

  PMID: 38679416 DERIVED

• 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.

  PMID: 35839791 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Antibiotic Prophylaxis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chemoprevention; Drug Therapy; Therapeutics; Premedication

Study Officials

• Eduard Baco, MD, PhD

  Oslo University Hospital, Oslo, Norway

  PRINCIPAL INVESTIGATOR

• Erik Rud, MD,PhD

  Oslo University Hospital, Oslo, Norway

  STUDY CHAIR

• Karsten Gunzel, MD

  Vivantes Klinkum Am Urban, Berlin, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Randomized study 1:1

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 31, 2019
• Study Start: November 11, 2019
• Primary Completion: February 28, 2021
• Study Completion: April 30, 2021
• Last Updated: December 7, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); NO (1)