A Study Comparing Infectious Complications After Transperineal Prostate Biopsy With or Without Antibiotic Prophylaxis

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 Criteria:

• 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 Criteria:

• Indwelling urinary catheter
• Active (symptomatic) urinary tract infection
• Immunodeficiency
• Use of immunosuppressive therapy
• Ongoing antibiotic therapy for another reason
• Uncontrolled diabetes mellitus
• Cardiac conditions requiring antibiotic prophylaxis for invasive procedures (e.g., prosthetic heart valves, etc.)
• Ongoing chemotherapy
• History of infectious complications following prostate biopsy