Perineal Versus Rectal Approach for Prostate Biopsy to Prevent Iatrogenic Infections

Study Overview
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Brief Summary
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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
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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.

Official Title
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Perineal Versus Rectal Approach for Prostate Biopsy to Prevent Iatrogenic Infections

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: Transperineal prostate biopsy
* Procedure: Transrectal prostate biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients who will have prostate biopsy will be randomized 1:1 among transperineal or transrecal approach
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transperineal prostate biopsy<br>Patient will have a transperineal prostate biopsy. | Procedure: Transperineal prostate biopsy<br>* Puncture of 12 to 30 percutaneous prostate core biopsies through the perineum with a transrectal ultrasound probe guidance. The procedure would be performed with the Artemis (Eigen) device allowing topographic recording of the puncture and MRI / ultrasound image fusion in order to target the MRI suspected lesion.<br>|
| Active Comparator: Transrectal prostate biopsy<br>Patient will have a transrectal prostate biopsy. | Procedure: Transrectal prostate biopsy<br>* Patient would undergo 12 to 30 transrectal prostate core biopsies through the rectum with a transrectal ultrasound probe guidance. The procedure would be performed with the Artemis (Eigen) device allowing topographic recording of the puncture and MRI / ultrasound image fusion in order to target the MRI suspected lesion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of post-biopsy infection from Baseline to four weeks after prostate biopsy | Urinary infection will be assessed based on urinanalysis : 10^5 germs and 10^4 leucocytes minimum) | Four weeks post-biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of antibiotic resistant germ | Antibiotic resistant germ will be assessed on urinanalysis | One week, two weeks and four weeks post-biopsy | 
| Presence of complication post-biopsy : hematuria, urinary retention, rectoragy, any other complication | Presence of complication will be assessed during phone interview with the patient | One week, two weeks and four weeks post-biopsy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate biopsy approach, Transrectal prostate biopsy, Transperineal prostate biopsy, Iatrogenic infection, Prevention