TransPERineal Fusion Biopsy Versus transrECTal

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

Detailed Description
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: Biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: transperineal biopsy<br>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<br>* patient must have a biopsy for his prostate cancer<br>|
| Active Comparator: transrectal biopsy<br>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<br>* patient must have a biopsy for his prostate cancer<br>|

What is the study measuring?
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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 |