Clinical trial · Interventional
Infective Complications in TP Biopsy Without Antibiotic Prophylaxis
Infective Complications in Transperineal Prostate Biopsy Without Antibiotic Prophylaxis: A Prospective Cohort Study
NCT06359964CI-TRIAL-00115789completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a prospective cohort study to delineate the infective outcomes and incidence after transperineal prostate biopsy with no antibiotic prophylaxis, compared to the existing data on outcomes on patients receiving transperineal prostate biopsy with antibiotic prophylaxis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transperineal Biopsy with antibiotics prophylaxis | Procedure | — | UNRESOLVED |
| Transperineal Biopsy without antibiotics prophylaxis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TP BIospy without antibiotic prophylaxis
- description
- Transperineal Biopsy without antibiotic prophylaxis
- interventionNames
- Procedure: Transperineal Biopsy without antibiotics prophylaxis
- type
- ACTIVE_COMPARATOR
- label
- TP BIospy with antibiotic prophylaxis
- description
- Transperineal Biopsy with antibiotic prophylaxis
- interventionNames
- Procedure: Transperineal Biopsy with antibiotics prophylaxis
Primary outcomes (2)
- measure
- The difference in UTI hospitalization rate between the two groups after biopsy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All consecutive patients in participating centres receiving transperineal USG-guided biopsy for any indication including: * Elevated PSA * Abnormal DRE * Follow-up biopsy in active surveillance * Suspicion of CAP recurrence after radiotherapy * Follow-up biopsy after focal therapy * Consenting to the study Exclusion Criteria: * Recent suspected UTI within 1 month * Recent culture proven bacteriuria within 1 month * History of recurrent UTI * Indwelling urinary catheter * Immunocompromised state * High risk of infective endocarditis (including prosthetic heart valve, congenital heart disease, or previous history of infective endocarditis * Incompetent or incapable of understanding the nature of the study or giving informed consent
References
Publications (9)
- BACKGROUNDDerin O, Fonseca L, Sanchez-Salas R, Roberts MJ. Infectious complications of prostate biopsy: winning battles but not war. World J Urol. 2020 Nov;38(11):2743-2753. doi: 10.1007/s00345-020-03112-3. Epub 2020 Feb 24. PMID 32095882
- BACKGROUNDLi JKM, Wang LL, Lau BSY, Tse RTH, Cheng CKL, Leung SCH, Wong CYP, Tsui SKW, Teoh JYC, Chiu PKF, Ng CF. Oral antibiotics perturbation on gut microbiota after prostate biopsy. Front Cell Infect Microbiol. 2022 Aug 16;12:959903. doi: 10.3389/fcimb.2022.959903. eCollection 2022. PMID 36051239
- BACKGROUNDCastellani D, Pirola GM, Law YXT, Gubbiotti M, Giulioni C, Scarcella S, Wroclawski ML, Chan E, Chiu PK, Teoh JY, Gauhar V, Rubilotta E. Infection Rate after Transperineal Prostate Biopsy with and without Prophylactic Antibiotics: Results from a Systematic Review and Meta-Analysis of Comparative Studies. J Urol. 2022 Jan;207(1):25-34. doi: 10.1097/JU.0000000000002251. Epub 2021 Sep 24. PMID 34555932
- BACKGROUNDBasourakos SP, Alshak MN, Lewicki PJ, Cheng E, Tzeng M, DeRosa AP, Allaway MJ, Ross AE, Schaeffer EM, Patel HD, Hu JC, Gorin MA. Role of Prophylactic Antibiotics in Transperineal Prostate Biopsy: A Systematic Review and Meta-analysis. Eur Urol Open Sci. 2022 Jan 29;37:53-63. doi: 10.1016/j.euros.2022.01.001. eCollection 2022 Mar. PMID 35243391
- BACKGROUNDJacewicz M, Gunzel K, Rud E, Sandbaek G, Magheli A, Busch J, Hinz S, Baco E. Antibiotic prophylaxis versus no antibiotic prophylaxis in transperineal prostate biopsies (NORAPP): a randomised, open-label, non-inferiority trial. Lancet Infect Dis. 2022 Oct;22(10):1465-1471. doi: 10.1016/S1473-3099(22)00373-5. Epub 2022 Jul 12. PMID 35839791
- BACKGROUNDSinghal U, Qi J, Daignault-Newton S, George AK. Antibiotic prophylaxis for transperineal prostate biopsy? An unanswered question. Lancet Infect Dis. 2022 Dec;22(12):1662. doi: 10.1016/S1473-3099(22)00738-1. Epub 2022 Nov 7. No abstract available.