Spots Global Cancer Trial Database for Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate Lesions

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

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

Study ID: NCT01657942

Conditions

Localized Intermediate Risk Prostate Lesions

Interventions

ExAblate MR Guided Focused Ultrasound

Study Description

Brief Summary: The hypothesis of this study is that focal treatment with ExAblate MRgFUS has the potential to be an effective non-invasive treatment for intermediate risk, organ-confined prostate lesions, with a low incidence of morbidity. The study hypothesis will be tested by measuring treatment-related safety and initial effectiveness parameters in the ExAblate MRgFUS treated patients, as described above.

Detailed Description: 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).