Clinical trial · Interventional
Perineal Versus Rectal Approach for Prostate Biopsy to Prevent Iatrogenic Infections
NCT03496142CI-TRIAL-00032488PRAPIunknownN/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)
Retrospective reports from literature have shown a lower rate of infections for transperineal versus transrectal approach for prostate biopsies in the setting of prostate cancer suspicion. The aim of this study would be to compare in a prospective randomized trial the rate of infection with transperineal versus transrectal approach.
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 prostate biopsy | Procedure | — | UNRESOLVED |
| Transrectal prostate biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Transperineal prostate biopsy
- description
- Patient will have a transperineal prostate biopsy.
- interventionNames
- Procedure: Transperineal prostate biopsy
- type
- ACTIVE_COMPARATOR
- label
- Transrectal prostate biopsy
- description
- Patient will have a transrectal prostate biopsy.
- interventionNames
- Procedure: Transrectal prostate biopsy
Primary outcomes (1)
- measure
- Rate of post-biopsy infection from Baseline to four weeks after prostate biopsy
- timeFrame
- Four weeks post-biopsy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Indication of prostate biopsy Exclusion Criteria: * No indication of prostate biopsy * Impossibility for prostate biopsy (e.g. major anal stenosis or history of anal amputation) * Antibiotic treatment within three months before prostate biopsy
References
Publications (0)
Data not yet available
No reference posted for this study.