TransPERineal Fusion Biopsy Versus transrECTal

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Procedure: Biopsy

• Registration Number: NCT05069584
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

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.

Study Timeline

• Study First Submitted: 2021-09-24
• Study First Submitted QC: 2021-09-24
• Study First Posted: 2021-10-06
• Study Start: 2022-01-17
• Status Verified: 2023-05
• Primary Completion: 2023-05-12
• Study Completion: 2023-05-12
• Last Update Submitted: 2023-05-22
• Last Update Posted: 2023-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 270

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
transrectal biopsy	Biopsy	The comparison strategy is based on performing targeted and systematized prostate biopsies performed by the transrectal route. Biopsy must be performed as part of the usual treatment for prostate cancer diagnosis.
transperineal biopsy	Biopsy	The strategy evaluated is based on performing targeted and systematized prostate biopsies performed by the transperineal route. Biopsy must be performed as part of the usual treatment for prostate cancer diagnosis.

Primary Outcome Measures

Name	Time	Method
Efficacy of the targeted biopsy in terms of detection of significant cancers.	Day 21	Number of patients (%) diagnosed with International Society of Urological Pathology cancer grade ≥ 2 on targeted biopsies.

Trial Locations

Locations (1)

Clinique La Croix Sud; 🇫🇷 Quint-Fonsegrives, France