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A Study Comparing Infectious Complications After Transperineal Prostate Biopsy With or Without Antibiotic Prophylaxis.
Sponsor: F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
Summary
Prostate biopsy performed through the perineal skin (the area between the testicles and the anus), known as a transperineal biopsy, is currently considered the standard procedure for diagnosing prostate tumors, having replaced the biopsy performed directly through the rectum. A prostate biopsy involves taking small samples of tissue from the prostate in order to confirm or rule out suspicious changes. The reason for this shift is the lower risk of infectious complications. For this type of biopsy, it has not yet been clearly established whether preventive administration of antibiotics is necessary. Existing studies indicate that the incidence of infection is similar even without antibiotic prophylaxis. The aim of the monitoring is to confirm the safety of performing transperineal prostate biopsy without the use of antibiotics.
Official title: A Prospective Randomised Non-Inferiority Study Comparing Infectious Complications After Transperineal Prostate Biopsy
Key Details
Gender
MALE
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2026-04-01
Completion Date
2027-04-01
Last Updated
2026-05-11
Healthy Volunteers
No
Interventions
No antibiotic prophylaxis for prostate biopsy
The study includes patients who received antibiotic prophylaxis for prostate biopsy, compared with a second arm consisting of patients who did not receive antibiotics during the procedure.
Antibiotic prophylaxis (fosfomycin-trometamol) for prostate biopsy.
Patients who received antibiotic prophylaxis (fosfomycin-trometamol) for prostate biopsy.
Locations (1)
F.D. Roosevelt teaching hospital
Banská Bystrica, Slovakia