Focal MR-Guided Focused Ultrasound Treatment of Localized Low-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 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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Focal MR-Guided Focused Ultrasound Treatment of Localized Low-Risk Prostate Cancer: Feasibility Study|
- Safety and initial Effectiveness [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]Incidence and severity of device/treatment related AE's from treatment and up to 24 months follow-up
- Effectiveness [ Time Frame: 24 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Assessing post-ExAblate non-perfused volume (NPV) changes from immediate post- treatment measurement to at 6 and 24 months
- QOL [ Time Frame: 24 months ] [ Designated as safety issue: No ]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 2014|
|Estimated Primary Completion Date:||December 2014 (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 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).
|University Health Network||Recruiting|
|Toronto, Ontario, Canada, M5G 2C4|
|Contact: Paula Spensieri 416-946-4501 ext 4958 firstname.lastname@example.org|
|Principal Investigator: John Trachtenberg, MD|
|Principal Investigator: Sangeet Ghai, MD|
|Sheba Medical Center||Not yet recruiting|
|Tel Hashomer, Israel|
|Contact: Zohar Dotan, MD +97235303030 email@example.com|
|Principal Investigator: Zohar Dotan, MD|
|Sub-Investigator: Yael Inbar, MD|
|Sub-Investigator: Orith Portnoy, MD|
|Sub-Investigator: Gil Raviv, MD|
|Sub-Investigator: Jacob Ramon, Prof. MD|
|Sub-Investigator: Eddie Friedman, MD|
|Sub-Investigator: Chaim Birkenshtadt, MD|
|Sapienza University Hospital||Not yet recruiting|
|Contact: Carlo Catalano, Prof. +39 (06) 4455602 firstname.lastname@example.org|
|Principal Investigator: Carlo Catalano, Prof, MD|
|Sub-Investigator: Alessandro Napoli, MD|
|Sub-Investigator: Giulia Brachetti, MD|
|National Cancer Center Singapore||Recruiting|
|Singapore, Singapore, 168753|
|Contact: Juriyah Yatim, RN email@example.com|
|St. Mary's Hospital||Not yet recruiting|
|London, United Kingdom|
|Contact: Wladyslaw Gedroyc, Prof. MD +442033126497 firstname.lastname@example.org|
|Principal Investigator: Wladyslaw Gedroyc, Prof. MD|