Perineal Versus Rectal Approach for Prostate Biopsy to Prevent Iatrogenic Infections

Not Applicable

• Conditions: Prostate Cancer
• Interventions: Procedure: Transperineal prostate biopsy; Procedure: Transrectal prostate biopsy

• Registration Number: NCT03496142
• Lead Sponsor: Institut Mutualiste Montsouris

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 Timeline

• Status Verified: 2018-04
• Study Start: 2018-04
• Study First Submitted: 2018-04-05
• Study First Submitted QC: 2018-04-05
• Last Update Submitted: 2018-04-05
• Study First Posted: 2018-04-12
• Last Update Posted: 2018-04-12
• Primary Completion: 2020-05
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 340

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transperineal prostate biopsy	Transperineal prostate biopsy	Patient will have a transperineal prostate biopsy.
Transrectal prostate biopsy	Transrectal prostate biopsy	Patient will have a transrectal prostate biopsy.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institut Mutualiste Montsouris; 🇫🇷 Paris, France