Clinical trial · Interventional
PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy
Evaluation of Transperineal Biopsy Under Local Anesthesia, a Novel Approach to Decrease Post-Biopsy Infections and Improve Cancer Detection
- 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)
Approximately one million transrectal prostate biopsies are performed annually in the U.S., and the risk of post- biopsy infection is increasing due to greater antibiotic resistance of rectal flora. Preliminary data demonstrates that a transperineal MRI-targeted biopsy approach under local anesthesia compared to the standard practice transrectal MRI-targeted prostate biopsy has a much lower risk of infection, comparable pain/discomfort and may improve detection of prostate cancer. This randomized controlled trial will be the first prospective study to evaluate in-office transperineal MRI targeted prostate biopsy. The investigators hypothesize that a transperineal MRI-targeted biopsy approach under local anesthesia compared to the standard practice transrectal MRI-targeted prostate biopsy has a much lower risk of infection, comparable pain/discomfort and may improve detection of prostate cancer.
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 |
|---|---|---|---|
| Infection | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Antibiotic (prophylaxis) | Drug | — | UNRESOLVED |
| Transperineal MRI-guided prostate biopsy | Procedure | — | UNRESOLVED |
| Transrectal MRI-guided prostate biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Transrectal
- description
- Patients will receive a transrectal MRI-guided prostate biopsy.
- interventionNames
- Procedure: Transrectal MRI-guided prostate biopsy
- Drug: Antibiotic (prophylaxis)
- type
- ACTIVE_COMPARATOR
- label
- Transperineal
- description
- Patients will receive a transperineal MRI-guided prostate biopsy.
- interventionNames
- Procedure: Transperineal MRI-guided prostate biopsy
Primary outcomes (1)
- measure
- Percentage of Subjects That Experienced Infection, Urinary Retention or Bleeding Requiring Intervention Within 7 Days of Biopsy Based on Transrectal Ultrasound Guided Prostate Biopsy Questionnaire (TRUS-BxQ)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Male sex * Age ≥18 years * Men without previous prostate biopsy (first time prostate biopsy) * Willingness to sign informed consent and adhere to the study protocol Exclusion Criteria * Acute prostatitis within the last 6 months * PSA \> 20 ng/mL in men who have previously undergone prostate biopsy * Current non-urologic bacterial infection requiring active treatment with antibiotics * Unfit to undergo prostate biopsy under local anesthesia * Prior definitive therapy for prostate cancer, such as radiation therapy or partial gland ablation * Men who have previously undergone prostate biopsy in whom artifact would reduce quality of prostate MRI (extensive orthopedic pelvic metal) * Contraindication to prostate MRI (claustrophobia, pacemaker, chronic kidney disease) in men who have previously undergone prostate biopsy
References
Publications (2)
- DERIVEDDriscoll CB, Handa N, Huang MM, Murphy AB, Hu JC, Schaeffer EM. Evaluating PI-RADS lesions and clinically significant prostate cancer in Black and Asian men: a PREVENT randomized clinical trial secondary analysis. Prostate Cancer Prostatic Dis. 2026 Jun;29(2):435-439. doi: 10.1038/s41391-025-01057-5. Epub 2025 Nov 26. PMID 41298852
- DERIVEDDriscoll C, Handa N, Huang M, Murphy A, Hu J, Schaeffer E. Evaluating PI-RADS lesions and clinically significant prostate cancer in Black and Asian men: a PREVENT randomized clinical trial secondary analysis. Res Sq [Preprint]. 2025 Jul 4:rs.3.rs-6905600. doi: 10.21203/rs.3.rs-6905600/v1. PMID 40630527