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

NCT04146142 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2021-12-07

No results posted yet for this study

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

Interventions

PROCEDURE

Transperineal prostate biopsy with or without antibiotic prophylaxis

As described above.

Sponsors & Collaborators

  • University of Oslo

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Eduard Baco, MD, PhD · Oslo University Hospital, Oslo, Norway

  • Erik Rud, MD,PhD · Oslo University Hospital, Oslo, Norway

  • Karsten Gunzel, MD · Vivantes Klinkum Am Urban, Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-11
Primary Completion
2021-02-28
Completion
2021-04-30

Countries

  • Germany
  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04146142 on ClinicalTrials.gov