Infectious Complications Following Prostate Biopsy, Prostate Cancer
Conditions
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.
Interventions
DIAGNOSTIC_TESTNo 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.
DRUGAntibiotic prophylaxis (fosfomycin-trometamol) for prostate biopsy.
Patients who received antibiotic prophylaxis (fosfomycin-trometamol) for prostate biopsy.
Sponsors
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of post-biopsy infectious complications. | At 3 weeks and at 2 months after the procedure |
Countries
Slovakia
Outcome results
None listed