Infections after prostate biopsy through the skin, with or without antibiotics
Compares infection rates after prostate biopsy done with or without fosfomycin-trometamol.
Plain-language title generated from the registry record
Registry title: A Study Comparing Infectious Complications After Transperineal Prostate Biopsy With or Without Antibiotic Prophylaxis
Key facts
- Where
- Banská Bystrica, SlovakiaSee the site
Where in Slovakia
- F.D. Roosevelt teaching hospitalBanská Bystrica, SlovakiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
- Trial code
- NCT07557901
- Record updated
- 15 May 2026
- Original description
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.Read full original descriptionShow less
A Prospective Randomised Non-Inferiority Study Comparing Infectious Complications After Transperineal Prostate Biopsy
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.
Inclusion: Suspicion of prostate cancer based on an elevated PSA level and/or findings on prostate MRI and/or a positive finding on digital rectal examination; Cognitive ability sufficient to understand and sign informed consent; Health status allowing for local anesthesia and a surgical procedure.
Exclusion: Use of immunosuppressive therapy; Ongoing antibiotic therapy for another reason; Ongoing chemotherapy; Active (symptomatic) urinary tract infection; Uncontrolled diabetes mellitus; Cardiac conditions requiring antibiotic prophylaxis for invasive procedures (e.g., prosthetic heart valves, etc.); History of infectious complications following prostate biopsy; Indwelling urinary catheter; Immunodeficiency.