drugset / Trial / NCT07557901

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

NCT07557901

RandomizedParallel-groupOpen-labelDiagnostic

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.

Timeline

Start
2026-04-01
Primary completion
2027-04-01
Completion
2027-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Fosfomycin Small molecule

Indications