NCT01657942

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: InSightec · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Localized Intermediate Risk Prostate Lesions

Interventions

Type	Name	Description
DEVICE	ExAblate MR Guided Focused Ultrasound	ExAblate MR Guided Focused Ultrasound - Local treatment of prostate lesions using Magnetic Resonance Imaging guided endorectally applied focused ultrasound energy.

Timeline

• Start date: 2013-10-01
• Primary completion: 2019-10-01
• Completion: 2021-05-01
• First posted: 2012-08-06
• Last updated: 2024-11-13
• Results posted: 2024-11-13

Locations

9 sites across 1 country: United States