NCT07557901Enrolling by invitation
A Study Comparing Infectious Complications After Transperineal Prostate Biopsy With or Without Antibiotic Prophylaxis
A Prospective Randomised Non-Inferiority Study Comparing Infectious Complications After Transperineal Prostate Biopsy
Source: ClinicalTrials.gov · Last updated 15 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 22 Apr 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT07557901
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 1 Apr 2026 to the primary completion date, 1 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of immunosuppressive therapy
- Ongoing antibiotic therapy for another reason
- Ongoing chemotherapy
Other illness
- Active (symptomatic) urinary tract infection
- Uncontrolled diabetes mellitus
- Cardiac conditions requiring antibiotic prophylaxis for invasive procedures (e.g., prosthetic heart valves, etc.)
- History of infectious complications following prostate biopsy
Other
- Indwelling urinary catheter
- Immunodeficiency
Who the study is looking for
- 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
Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| F.D. Roosevelt teaching hospital Coordinator of this site? Confirm its status | Banská Bystrica | Slovakia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.