TransPERineal Fusion Biopsy Versus transrECTal

NCT ID: NCT05069584

Last Updated: 2023-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-17
• Study Completion Date: 2023-05-12

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

transperineal 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.

Group Type: EXPERIMENTAL

Biopsy

Intervention Type: PROCEDURE

patient must have a biopsy for his prostate cancer

transrectal 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.

Group Type: ACTIVE_COMPARATOR

Biopsy

Intervention Type: PROCEDURE

patient must have a biopsy for his prostate cancer

Interventions

Biopsy

patient must have a biopsy for his prostate cancer

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique La Croix Sud

Quint-Fonsegrives, , France

Countries

France

Other Identifiers

2021-A01793-38

Identifier Type: -

Identifier Source: org_study_id