Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GCS Ramsay Santé pour l'Enseignement et la Recherche
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.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | TransPERineal Fusion Biopsy Versus transrECTal
