A Study Comparing Infectious Complications After Transperineal Prostate Biopsy With or Without Antibiotic Prophylaxis
Enrolling by invitation · Not applicable
Conditions studied: Infectious Complications Following Prostate Biopsy, Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT07557901
- Run by
- F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
- People needed
- 300
- Starts
- 2026-04-01
- Expected to finish
- 2027-04-01
- Last updated by the study team
- 2026-05-15
Who can join
Age: any. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- F.D. Roosevelt teaching hospital — Banská Bystrica, Slovakia
Full record on ClinicalTrials.gov
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