NCT05220501

Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 804 (actual)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Microultrasonography Targeted Biopsy	All subjects will be biopsied no matter their arm randomization. In this group, MicroUS targets will be identified and sampled.
DIAGNOSTIC_TEST	MRI Targeted Biopsy	All subjects will be biopsied no matter their arm randomization. In this group, mpMRI targets will be identified and sampled.

Timeline

• Start date: 2021-12-15
• Primary completion: 2024-09-06
• Completion: 2024-09-06
• First posted: 2022-02-02
• Last updated: 2025-11-10
• Results posted: 2025-11-10

Locations

22 sites across 8 countries: United States, Austria, Belgium, Canada, France, Germany, Italy, Spain

Regulatory

• FDA-regulated device study