NCT03496142

Perineal Versus Rectal Approach for Prostate Biopsy to Prevent Iatrogenic Infections

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 340 (estimated)
• Sponsor: Institut Mutualiste Montsouris · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	Transperineal prostate biopsy	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.
PROCEDURE	Transrectal prostate biopsy	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.

Timeline

• Start date: 2018-04-01
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2018-04-12
• Last updated: 2018-04-12

Locations

1 site across 1 country: France