Clinical trial · Observational
Reduction of Prostate Biopsy Morbidity
Reduction of Prostate Biopsy Morbidity and Hospitalization Through a Modified Biopsy Protocol Bundle and Region-specific Antibiogram
- 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)
Prostate biopsy is typically performed via either the transrectal or transperineal approach. This study is a case-control study being done to determine if a novel prostate biopsy protocol incorporating a transperineal approach, rectal swab to detect resistant bacteria and broad antibiotic prophylaxis will reduce infectious complications and hospital readmission compared to current biopsy practices.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transperineal biopsy Protocol | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- transperineal protocol
- description
- 1. Transperineal biopsy approach with avoidance of rectal flora 2. MRI-ultrasound fusion-guided biopsies with reduced number of biopsy cores, where clinically indicated 3. Rectal swab to identify the presence of fluoroquinolone resistant (FQR) bacteria 4. Multi-antibiotic prophylaxis 5. Urine culture, prostate tissue culture and rectal swab culture to define contemporary, region-specific antibiotic resistance patterns.
- interventionNames
- Procedure: Transperineal biopsy Protocol
- label
- Traditional biopsy
- description
- 1. Transrectal approach 2. Standard 12-core template 3. Surgeon-specific antibiotic prophylaxis 4. Urine culture, prostate tissue culture and FQR rectal swab culture to define contemporary, region-specific antibiotic resistance patterns.
Primary outcomes (1)
- measure
- Rate of clinically significant post-biopsy complications
- timeFrame
- 30 Days
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria: * Male patients greater than 18 years of age * Indication for prostate biopsy Exclusion Criteria: * Female patients * Male patients under 18 years of age * No indication for prostate biopsy
References
Publications (0)
Data not yet available