Efficacy and Safety of Prostate Biopsies by Transperineal Versus Transrectal Route: Randomized Study

GCS Ramsay Santé pour l'Enseignement et la Recherche1 site in 1 country270 target enrollmentJanuary 17, 2022

ConditionsProstate Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Enrollment: 270
Locations: 1
Primary Endpoint: Efficacy of the targeted biopsy in terms of detection of significant cancers.
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Comparison of the efficacy and safety of 2 types of prostatic biopsies: transperineal biopsy versus transrectal biopsy.

Detailed Description

Interventional, comparative, randomized, controlled study in 2 parallel groups, open-label, longitudinal, multicenter, aimed at demonstrating the non-inferiority of targeted transperineal biopsies compared to targeted transrectal biopsies in terms of diagnostic efficiency.

Registry

clinicaltrials.gov

Start Date

January 17, 2022

End Date

May 12, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient having had a multiparametric prostatic MRI with the realization of 3 sequences (T2, diffusion, perfusion) interpreted by a local referent radiologist in prostate MRI or whose PI-RADS score is confirmed by rereading by a local referent radiologist in prostate MRI in case prostate MRI performed outside the center;
•Patient with at least one PI-RADS 4-5 lesion on MRI;
•Patient eligible for prostate, transperineal and transrectal biopsies, targeted and systematized;
•Patient with negative pre-biopsy antibacteriological urine examination ;
•Patient with prostate specific antigen (PSA) level ≤ 20 ng / mL;
•Patient capable of understanding the information related to the study, answering questionnaires in French, reading the instructions and having expressed their consent to participate in the study.

Exclusion Criteria

•Patient who has already had a prostate biopsy;
•Patient with stage ≥ cT3a prostate cancer according to TNM classification version 8
•Patient with negative MRI or whose lesions have a PI-RADS score \<4;
•Patient with impassable rectal stenosis;
•Patient with a dermatological disease preventing perineal access;
•Patient with rectal amputation;
•Patient presenting with a urinary tract infection;
•Patient on anticoagulant treatment at an effective oral dose, not relayed;
•Patient participating in another clinical trial, or in a period of exclusion from another clinical trial