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.
Trial 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. Read more about this study
- 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
- Are there results?
- Not yet: the study is under way
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
Show all 9Show fewer
- 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.
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Viktor Kováčik, F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
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
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Non-Inferiority Study Comparing Infectious Complications After Transperineal Prostate Biopsy
- ClinicalTrials.gov ID
- NCT07557901
- Acronym / sponsor ID
- 01
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- F.D. Roosevelt Teaching Hospital with Policlinic Banska BystricaUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic prophylaxis group | Experimental | Drug: Antibiotic prophylaxis (fosfomycin-trometamol) for prostate biopsy.The study arm includes patients who received antibiotic prophylaxis for prostate biopsy. |
| NO-Antibiotic prophylaxis group | Experimental | Diagnostic Test: No antibiotic prophylaxis for prostate biopsyThe study arm includes patients who received no antibiotic prophylaxis for prostate biopsy. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- Indwelling urinary catheter
- Active (symptomatic) urinary tract infection
- Immunodeficiency
- Use of immunosuppressive therapy
- Ongoing antibiotic therapy for another reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No antibiotic prophylaxis for prostate biopsyThe 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. | Diagnostic test | NO-Antibiotic prophylaxis group |
| Antibiotic prophylaxis (fosfomycin-trometamol) for prostate biopsy.Patients who received antibiotic prophylaxis (fosfomycin-trometamol) for prostate biopsy. | Drug | Antibiotic prophylaxis group |
Primary outcome
The incidence of post-biopsy infectious complications.
Time frame: At 3 weeks and at 2 months after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
Related trials for Infectious Complications Following Prostate Biopsy
Recruiting
Routine Probe Compression After Transrectal Prostate Biopsy(RPCAB) to Reduce Bleeding and Infectious Complications
Prostate Biopsy, Post Biopsy Bleeding
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of post-biopsy infectious complications. (time frame: At 3 weeks and at 2 months after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.