TransPERineal Fusion Biopsy Versus transrECTal (PERFECT)

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

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

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: 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 Type: Interventional
• Enrollment (Actual): 270
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Quint-Fonsegrives, France, 31130
    • Clinique La Croix Sud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Biopsy; patient must have a biopsy for his prostate cancer
Active Comparator: 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.	Procedure: Biopsy; patient must have a biopsy for his prostate cancer

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2022
• Primary Completion (Actual): May 12, 2023
• Study Completion (Actual): May 12, 2023

Study Registration Dates

• First Submitted: September 24, 2021
• First Submitted That Met QC Criteria: September 24, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2021-A01793-38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No