Perineal Versus Rectal Approach for Prostate Biopsy to Prevent Iatrogenic Infections
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 340
- Locations
- 2
- Primary Endpoint
- Rate of post-biopsy infection from Baseline to four weeks after prostate biopsy
Study Overview
Brief Summary
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.
Detailed Description
Retrospective reports from literature have shown a lower rate of infections for the transperineal versus transrectal approach for prostate biopsies in the setting of prostate cancer suspicion.
Post-biopsy infection is becoming a more and more challenging situation due to the increase of incidence and development of antibiotic resistant germs.
The aim of this study would be to compare in a prospective randomized trial the rate of infection with transperineal vs transrectal approach.
Patient presenting an indication of prostate biopsy (PSA elevation, suspicious lesion at digital rectal, suspicious lesion on MRI) would be randomized 1:1 among transrectal vs transperineal biopsies.
Post-biopsy infection would be monitored by systemic urine analysis at one, two and four weeks after procedure and in case of clinical symptoms.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Transperineal prostate biopsy
Patient will have a transperineal prostate biopsy.
Intervention: Transperineal prostate biopsy (Procedure)
Transrectal prostate biopsy
Patient will have a transrectal prostate biopsy.
Intervention: Transrectal prostate biopsy (Procedure)
Outcomes
Primary Outcomes
Rate of post-biopsy infection from Baseline to four weeks after prostate biopsy
Time Frame: Four weeks post-biopsy
Urinary infection will be assessed based on urinanalysis : 10\^5 germs and 10\^4 leucocytes minimum)
Secondary Outcomes
- Presence of antibiotic resistant germ(One week, two weeks and four weeks post-biopsy)
- Presence of complication post-biopsy : hematuria, urinary retention, rectoragy, any other complication(One week, two weeks and four weeks post-biopsy)