Infectious Complications Following Prostate BiopsyNCT07557901

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

A study testing No antibiotic prophylaxis for prostate biopsy and Antibiotic prophylaxis (fosfomycin-trometamol) for prostate biopsy. in people with Infectious Complications Following Prostate Biopsy and Prostate Cancer, run by F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica at 1 site in Slovakia.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

Who is it for?: Any age, men only
Conditions the study is for: Infectious Complications Following Prostate Biopsy, Prostate Cancer
What is being tested?: No antibiotic prophylaxis for prostate biopsy and Antibiotic prophylaxis (fosfomycin-trometamol) for prostate biopsy.
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 1 siteSlovakia
Study dates: 1 Apr 2026to 1 Apr 2027
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
Men only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

Indwelling urinary catheter
Active (symptomatic) urinary tract infection
Immunodeficiency
Use of immunosuppressive therapy
Ongoing antibiotic therapy for another reason
Uncontrolled diabetes mellitus

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Cardiac conditions requiring antibiotic prophylaxis for invasive procedures (e.g., prosthetic heart valves, etc.)
Ongoing chemotherapy
History of infectious complications following prostate biopsy

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Slovakia1 site

F.D. Roosevelt teaching hospital
Banská Bystrica

Other trials in Slovakia

About this study

Official title: 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.

Conditions: Infectious Complications Following Prostate Biopsy, Prostate Cancer
Being tested: No antibiotic prophylaxis for prostate biopsy, Antibiotic prophylaxis (fosfomycin-trometamol) for prostate biopsy.
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No antibiotic prophylaxis for prostate biopsyDiagnostic 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.

Study groups in NCT07557901
Study group	Role	What they receive
Antibiotic prophylaxis group	Experimental	The study arm includes patients who received antibiotic prophylaxis for prostate biopsy. Receives: 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. Receives: Diagnostic Test: No antibiotic prophylaxis for prostate biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

The incidence of post-biopsy infectious complications.
Measured: At 3 weeks and at 2 months after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20261 Apr 2027

First posted30 Apr 2026
Study start1 Apr 2026
Primary completion1 Apr 2027 (estimated)
Study completion1 Apr 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Infectious Complications Following Prostate BiopsyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 300 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07557901
Sponsor's protocol ID: 01
Status last verified: May 2026
First submitted: 22 Apr 2026
Last updated: 15 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No