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

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Infectious Complications Following Prostate Biopsy Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

F.D. Roosevelt teaching hospital

Banská Bystrica, Slovakia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No antibiotic prophylaxis for prostate biopsy

Diagnostic Test

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.

Drug

Patients who received antibiotic prophylaxis (fosfomycin-trometamol) for prostate biopsy.

Primary outcomes

The incidence of post-biopsy infectious complications.

Time frame: At 3 weeks and at 2 months after the procedure

Sponsors and collaborators

Lead sponsor

F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

Other

Registry information

Official study title

A Prospective Randomised Non-Inferiority Study Comparing Infectious Complications After Transperineal Prostate Biopsy

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Apr 30, 2026
Registry last updated: May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Enrolling by Invitation