Eur Urol Oncol. 2026 Mar 10:S2588-9311(26)00040-4. doi: 10.1016/j.euo.2026.02.003. Online ahead of print.
ABSTRACT
BACKGROUND AND OBJECTIVE: 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.
CLINICAL TRIAL DESIGN AND TIMEFRAME: 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.
ENDPOINTS: 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.
DATA SOURCES AND STATISTICAL ANALYSIS PLAN: 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 AND LIMITATIONS: Strengths include the prospective and multicentre design. The main limitation is the open-label design.
FUNDING: TARGET is funded by Ramsay Générale de Santé (Paris, France), and supported by the Prostate Cancer Committee of Association Française d’Uologie.
ETHICS AND TRIAL REGISTRATION: The trial was assessed by the CPP Ouest VI ethics committee and is registered on ClinicalTrials.gov as NCT07296042.
PATIENT SUMMARY: 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.
PMID:41813528 | DOI:10.1016/j.euo.2026.02.003
