Localized Low-Intermediate Risk Prostate Cancer Clinical Trial
Official title:
Focal MR-Guided Focused Ultrasound Treatment of Localized Low-Intermediate Risk Prostate Cancer: Feasibility Study
The hypothesis of this feasibility study is that focal treatment with ExAblate MRgFUS has the
potential to be a safe and effective non-invasive treatment for low to intermediate risk,
organ-confined prostate cancer involving 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.
Based on the result of this study, InSightec will initiate a larger study in an effort to
approve low risk, organ-confined prostate cancer as an indication for its ExAblate MRgFUS
device.
Objective of this feasibility trial is to assess safety and initial effectiveness of ExAblate
MRgFUS in the treatment of low to intermediate risk, localized (organ confined) prostate
cancer tumors.
ExAblate treatment will be implemented as a focal tumor-selective therapy, directed at
pre-defined volume(s)/sector(s) in the prostate, (identified as cancerous by mapping biopsy
with or without 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 low risk organ confined prostate cancer. The risk of ExAblate
treatment-related incontinence and impotence will also be assessed in this study.
Effectiveness: determine the tumor control effect of ExAblate's MRgFUS focal treatment of low
risk organ-confined prostate cancer (confirmed by TRUS-guided Transperineal Mapping Biopsy
results).
;