An interventional study of Transperineal prostate biopsy with or without antibiotic prophylaxis in Prostate Biopsy and Antibiotic, sponsored by Oslo University Hospital. Completed at 2 sites in 2 countries. Open to male participants. Per ClinicalTrials.gov, last updated 2021-12-07.
Sponsored by Oslo University Hospital · Not applicable, Interventional, and Treatment
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.
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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Inclusion Criteria: Clinical indication for prostate cancer
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Exclusion Criteria:
Patients with high risk for infective endocarditis [European Society of Cardiology]
Cefuroxim 1.5 g will be applied intramuscularly before prostate biopsy
Procedure: Transperineal prostate biopsy with or without antibiotic prophylaxis
No antibiotics will be used before or after prostate biopsy
Procedure: Transperineal prostate biopsy with or without antibiotic prophylaxis
As described above.
Incidence of sepsis
Post biopsy sepsis will be defined by SIRS criteria
Time frame: Up to 30 days
Incidence of post biopsy urinary tract infection
Post biopsy urinary tract infection not demanding hospital admission within 30
Time frame: Up to 30 days
Pain during the local anesthesia application
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.
Time frame: Immediately after the intervention
Pain during the prostate biopsy
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.
Time frame: Immediately after the intervention
Plan to share: No — All data generated during this study will be evaluated at Oslo University Hospital
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Oslo University Hospital