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

NCT07557901 | Enrolling By Invitation

• 1 other identifier: 01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer; Infectious Complications Following Prostate Biopsy

Outcome Measures

Primary Outcomes (1)

• The incidence of post-biopsy infectious complications.

  At 3 weeks and at 2 months after the procedure

Study Arms (2)

Antibiotic prophylaxis group

EXPERIMENTAL

The study arm includes patients who received antibiotic prophylaxis for prostate biopsy.

Drug: Antibiotic prophylaxis (fosfomycin-trometamol) for prostate biopsy.

NO-Antibiotic prophylaxis group

EXPERIMENTAL

The study arm includes patients who received no antibiotic prophylaxis for prostate biopsy.

Diagnostic Test: No antibiotic prophylaxis for prostate biopsy

Interventions

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.

NO-Antibiotic prophylaxis group

Antibiotic prophylaxis (fosfomycin-trometamol) for prostate biopsy. DRUG

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

Antibiotic prophylaxis group

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica: lead

Study Sites (1)

F.D. Roosevelt teaching hospital

Banská Bystrica, Slovakia

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Antibiotic Prophylaxis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chemoprevention; Drug Therapy; Therapeutics; Premedication

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr.

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 30, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

SL (1)