Spots Global Cancer Trial Database for Perineal Versus Rectal Approach for Prostate Biopsy to Prevent Iatrogenic Infections

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Trial Identification

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

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

Study ID: NCT03496142

Conditions

Prostate Cancer

Interventions

Transperineal prostate biopsy

Transrectal prostate biopsy

Study Description

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.