N/A
N=687
PReclude Infection EVEnts With No Prophylaxis Transperineal Biopsy
Infection
Bottom Line
View on ClinicalTrials.gov: NCT04843566 ↗Enrolled (actual)
687
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: 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) — 1.4; 0; 1.1; 0.3 percentage of participants — p=0.04
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transperineal MRI-guided prostate biopsy (Procedure); Transrectal MRI-guided prostate biopsy (Procedure); Antibiotic (prophylaxis) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
1.4; 0; 1.1; 0.3; 0.4; 0 | 0.04 sig |
| SECONDARY Percentage of Patient Reporting Biopsy Pain and Discomfort |
3.0; 3.7; 3.8; 4.2; 3.6; 4.5 | 0.002 sig |
| SECONDARY Change in Patient-reported Anxiety, as Measured on a 0-10 Likert Scale |
4.2; 3.9 | 0.23 |
| SECONDARY Detection of Clinically Significant Disease as Measured by Gleason Grade Group ≥ 2 |
141; 151; 62; 49; 77; 87 | 0.59 |
| SECONDARY Change in Adverse Events, as Measured on Transrectal Ultrasound Guided Prostate Biopsy Questionnaire (TRUS-BxQ) |
4; 0; 3; 1; 1; 0 | 0.04 sig |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04843566). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.