Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate Lesions

Objective of this pivotal trial is to assess safety and initial effectiveness of ExAblate MRgFUS in the treatment of intermediate risk, localized (organ confined) prostate lesions. ExAblate treatment will be implemented as a focal lesion-selective therapy, directed at pre-defined volume(s)/sector(s) in the prostate, identified by mapping biopsy and multi-parametric MRI, rather than a whole gland or hemi-ablation treatment. Safety: evaluate incidence and severity of adverse events associated with ExAblate's MRgFUS focal treatment of intermediate risk organ confined prostate lesions. The risk of ExAblate treatment-related incontinence and impotence will also be assessed in this study. Effectiveness: determine the lesion control effect of ExAblate's MRgFUS focal treatment of intermediate risk organ-confined prostate lesions (confirmed by IMAGE-guided mapping biopsy results).