The big news from yesterday is that the Food and Drug Administration (FDA) has approved a MRI-guided, focused ultrasound therapy for the treatment of bone pain associated with metastatic advanced prostate cancer.
In a media release written by InSight, an Israeli company states that its ExAblate® MRI-guided, focused ultrasound technology is indicated to treat pain from bone metastases in patients with advanced prostate cancer who do not respond or cannot undergo radiation treatment for their bone pain. The quantity of allowable radiation is limited and once the threshold has been reached the only alternative a man with advanced prostate cancer currently has available are heavy duty pain drugs, including opiates and methadone.
Severe bone pain is common in men with late stage advanced prostate cancer. This approval could have a significant impact on men in this situation, providing pain relief without all the associated side effects of pain medication.
The FDA approval was based an international, multi-center, randomized clinical trial. The trial included sites in over 15 centers including Fox Chase Cancer Canter, Stanford University, UCSD, UVA, Moffitt, and Brigham and Women’s Hospital in the US as well as University of Toronto, La Sapienza University in Rome, Sheba and Rambam Medical Centers in Israel, Petrov Research Institute of Oncology and Rostov Medical University in Russia. According to Dr. Kobi Vortman, President and CEO of InSightec,the trial provided data that showed “ExAblate therapy significantly reduces pain caused by bone metastases” and that “Patients also reported lasting improvement in well being and function, along with a decrease in the need for medication.”
The therapy system uses a combination of acoustic ultrasound waves with continuous guidance and treatment monitoring with an MRI. Clinicians use the MRI to plan and guide the focused ultrasound therapy and monitor treatment outcome. The ultrasound energy destroys the nerves causing the pain, leading to a significant reduction in pain as well as an overall improvement of their quality of life.
Currently there are over 20 specialized centers in Europe, Asia and Australia capable of providing this type of MRI-guided, focused ultrasound therapy There has not been any indication where in the United States this treatment will become available, but it is a reasonable assumption that the American centers involved in the trial will be given the opportunity.
The FDA is requiring InSightec to carry out a multi-center post-marketing study of 70 US patients with painful bone metastases and to establish a registry to collect data about patients undergoing ExAblate therapy among other, similar patients.
Joel T. Nowak, M.A., M.S.W.