Multiparametric magnetic resonance imaging (mpMRI) with targeted biopsies improves detection of clinically significant prostate cancer (csPC), commonly defined as Gleason grade group (GG) ≥2. Current practice combines targeted and systematic biopsies, which increases csPC detection but also increases detection of insignificant PC (GG 1), which contributes to overdiagnosis.
Perilesional sampling around MRI-visible lesions has been proposed as a strategy to mitigate targeting imprecision while limiting sampling outside the MRI lesion area and GG 1 detection. The primary objective is to determine the diagnostic performance of the experimental targeted + perilesional biopsy scheme for detection of csPC in comparison to the standard targeted + systematic biopsy scheme.
TARGET is a prospective, multicentre, open-label, comparative clinical trial. Each patient acts as their own control, as each patient will undergo all three types of biopsy (targeted, perilesional, and systematic). The inclusion period will last for 21 mo, and the participation duration for each patient is 3 mo.
The primary endpoint is the sensitivity and specificity of the targeted + perilesional scheme for csPC detection in comparison to the targeted + systematic scheme. Secondary endpoints include differences in the detection rate for insignificant PC (GG 1) and aggressive PC (GG ≥3) between the experimental and standard biopsy schemes.
The data collected will include patient demographics and laboratory, radiology, and pathology reports. Analyses will be performed with SAS version 9.4 using a locked database.
Strengths include the prospective and multicentre design. The main limitation is the open-label design.
TARGET is funded by Ramsay Générale de Santé (Paris, France), and supported by the Prostate Cancer Committee of Association Française d'Uologie.
The trial was assessed by the CPP Ouest VI ethics committee and is registered on ClinicalTrials.gov as NCT07296042.
Our multicentre trial is comparing two different approaches for prostate biopsy to determine if sampling the area around lesions seen on an MRI (magnetic resonance imaging) scan can maintain the detection rate for clinically significant prostate cancer while reducing detection of low-risk disease.
European urology oncology. 2026 Mar 10 [Epub ahead of print]
Michael Baboudjian, Federica Sordelli, Jean-Jacques Patard, Bahjat Moussi, Vivien Graffeille, Victor Basset, Dorian Legraverend, Cyrille Bastide, Laurent Daniel, Jean-Baptiste Beauval, Morgan Rouprêt, Gregoire Robert, Guillaume Ploussard
Department of Urology, North Hospital, AP-HM, Aix-Marseille University, Marseille, France; INSERM U1326, CERIMED 13005, Aix-Marseille University, Marseille, France., Department of Urology, North Hospital, AP-HM, Aix-Marseille University, Marseille, France; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy. Electronic address: ., Department of Urology, CH Mont-de-Marsan, Mont-de-Marsan, France., Department of Urology, Hôpital des Peupliers, Paris, France., Department of Pathology, La Timone Hospital, Aix-Marseille University, Marseille, France., Department of Urology, La Croix du Sud Hôpital, Quint Fonsegrives, France., GRC 5 Predictive Onco-Uro Group, Department of Urology, Pitie-Salpetriere Hospital, AP-HP, Sorbonne University, Paris, France., Department of Urology, University Hospital Bordeaux, Bordeaux, France.
PubMed http://www.ncbi.nlm.nih.gov/pubmed/41813528