TransPERineal Fusion Biopsy Versus transrECTal

Prostate Cancer Clinical Trial

— PERFECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05069584
• Other study ID #: 2021-A01793-38
• Status: Completed
• Phase: N/A
• Start date: January 17, 2022
• Est. completion date: May 12, 2023

Study information

• Verified date: May 2023
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: May 12, 2023
• Est. primary completion date: May 12, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Biopsy
patient must have a biopsy for his prostate cancer

Locations

Country	Name	City	State
France	Clinique La Croix Sud	Quint-Fonsegrives

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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