A Phase 3 Study Comparing High Resolution Micro-ultrasound and Multiparametric MRI for Prostate Cancer Screening in Men Aged 50 to 70

What this Trial Is About

Researchers are evaluating whether a new imaging method called high resolution micro-ultrasound microUS, approved by the FDA and Health Canada, is as effective as the current standard imaging technique, multiparametric MRI, for screening the prostate gland. This phase 3 clinical trial aims to identify which imaging approach better guides the decision to proceed with a prostate biopsy in men aged 50 to 70 who are at risk for prostate cancer. Participants will be randomly assigned to one of two groups to receive either the standard prostate multiparametric MRI or the experimental microUS imaging. These imaging procedures will be compared to assess their ability to detect prostate abnormalities. The study is conducted at multiple centers internationally, and both imaging methods are non-invasive diagnostic devices. Men enrolled in the study will be followed for one year after their imaging test to monitor the detection of clinically significant prostate cancer. Researchers will collect data on imaging results and biopsy decisions to evaluate each methods effectiveness. Participants will undergo standard clinical assessments, and study visits will be scheduled to track outcomes during the follow-up period.

Screening for Prostate Cancer Using High Resolution Micro-ultrasound Versus Multiparametric Magnetic Resonance Imaging.