An interventional study of No antibiotic prophylaxis for prostate biopsy and Antibiotic prophylaxis (fosfomycin-trometamol) for prostate biopsy. in Infectious Complications Following Prostate Biopsy and Prostate Cancer, sponsored by F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica. Enrolling by invitation at 1 site in Slovakia. Open to male participants. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica · Not applicable, Interventional, and Diagnostic
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 300 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study arm includes patients who received antibiotic prophylaxis for prostate biopsy.
Drug: Antibiotic prophylaxis (fosfomycin-trometamol) for prostate biopsy.
The study arm includes patients who received no antibiotic prophylaxis for prostate biopsy.
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.
Patients who received antibiotic prophylaxis (fosfomycin-trometamol) for prostate biopsy.
The incidence of post-biopsy infectious complications.
Time frame: At 3 weeks and at 2 months after the procedure
Started Apr 2026 (actual). Primary completion is estimated for Apr 2027, 12 months after the start.
Of 1,098 non-industry interventional studies with no phase under Prostatic Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 86. This study's planned 12 months is below that.
Counting every sponsor, half of 1,155 studies reached it within 43 months; a quarter within 22 and three quarters within 84.
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F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica