A Study Comparing Infectious Complications After Transperineal Prostate Biopsy With or Without Antibiotic Prophylaxis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No antibiotic prophylaxis for prostate biopsy, Antibiotic prophylaxis (fosfomycin-trometamol) for prostate biopsy..
- Who it may be relevant to
- Registry conditions: Infectious Complications Following Prostate Biopsy, Prostate Cancer. Basic parameters: No limits · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Slovakia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Randomised Non-Inferiority Study Comparing Infectious Complications After Transperineal Prostate Biopsy
Overview
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.
Interventions
- Diagnostic test No antibiotic prophylaxis for prostate biopsy
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. - Drug Antibiotic prophylaxis (fosfomycin-trometamol) for prostate biopsy.
Patients who received antibiotic prophylaxis (fosfomycin-trometamol) for prostate biopsy.
Primary outcome measures
- The incidence of post-biopsy infectious complications. [Time frame: At 3 weeks and at 2 months after the procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Slovakia · 1 center
- F.D. Roosevelt teaching hospital — Banská Bystrica
Identifiers
NCT: NCT07557901 · 01