Spots Global Cancer Trial Database for Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI

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Trial Identification

Brief Title: Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI

Official Title: Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI: A 3-arm Randomized Controlled Trial Evaluating the Role of 29MHz Micro-ultrasound in Guiding Prostate Biopsy in Men With Clinical Suspicion of Prostate Cancer.

Study ID: NCT05220501

Conditions

Prostate Cancer

Interventions

Micro-US Targeted Biopsy

MRI Targeted Biopsy

Study Description

Brief Summary: OPTIMUM is a study designed to compare the ability of ultra-high resolution transrectal micro-ultrasound (microUS) and multiparametric MRI (mpMRI)/US fusion to guide prostate biopsy.

Detailed Description: The purpose of the Clinical Investigation Plan and Study Protocol is to present information for the OPTIMUM clinical investigation, including the scientific basis for the study, the procedural details, the ExactVu High Resolution Micro-Ultrasound System, its safety details, and administrative details. It has been designed in such a way as to optimize the scientific validity and reproducibility of the results of the study in accordance with current clinical knowledge and practice so as to fulfill the objectives of the investigation.