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.
|Localized Low-Intermediate Risk Prostate Cancer||Device: MRgFUS Treatment||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Focal MR-Guided Focused Ultrasound Treatment of Localized Low-Intermediate Risk Prostate Cancer: Feasibility Study|
- Safety and initial Effectiveness [ Time Frame: 6 months ]
- Safety: incidence and severity of device/treatment related AEs from treatment and up to 6 months follow-up
- Evaluating Initial effectiveness of ExAblate MRgFUS to achieve adequate tumor control in low risk organ-confined prostate cancer patients, based on 6-mo Transperineal (TP) mapping biopsy (Bx) findings
- Safety [ Time Frame: 24 months ]Incidence and severity of device/treatment related AE's from treatment and up to 24 months follow-up
- Effectiveness [ Time Frame: 24 months ]Evaluating effectiveness of ExAblate MRgFUS to achieve adequate tumor control in low risk organ-confined prostate cancer patients based on periodic PSA follow-up (according to study schedule) and TPBx (Transperineal Biopsy) at two years follow-up. (TPBx will be performed between 6 and 24 months, if clinically indicated)
- Effectiveness [ Time Frame: 24 months ]Assessing post-ExAblate non-perfused volume (NPV) changes from immediate post- treatment measurement to at 6 and 24 months
- QOL [ Time Frame: 24 months ]Patients will complete the EPIC-SF12-AUASI questionnaire periodically during study (from baseline up to 24 months post treatment), according to study schedule, to evaluate patient function and satisfaction after prostate cancer treatment.
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
ExAblate Treatment Arm
Device: MRgFUS Treatment
Local treatment of prostate cancer using Magnetic Resonance Imaging guided endorectally applied focused ultrasound energy
Other Name: ExAblate 2100 Prostate system
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226576
|University Health Network|
|Toronto, Ontario, Canada, M5G 2C4|
|Sheba Medical Center|
|Tel Hashomer, Israel|
|Sapienza University Hospital|
|National Cancer Center Singapore|
|Singapore, Singapore, 168753|
|St. Mary's Hospital|
|London, United Kingdom|