MRI-guided focused ultrasound is a new noninvasive focal treatment approach for localized low- and intermediate-risk prostate cancer. It has been in clinical study the in the U.S. for the past several years in order to evaluate its safety, effectiveness and side effect profile. The Sperling Prostate Center, along with eight other important medical centers, is proud to have been a study site in demonstrating to the FDA (Food & Drug Administration) the merits of this treatment for properly qualified patients. As a result, the device used to deliver the treatment has received FDA clearance.
The device, called the Exablate Prostate system, is manufactured by Insightec, a global healthcare company. Insightec, the sponsor of the 9-center clinical study, announced on Dec. 1, 2021 that their device had received FDA 510K clearance for ablating prostate tissue with high intensity Focused Ultrasound.[i]
As designed, the Exablate Prostate system relies on MRI guidance to plan and map the delivery of high intensity focused ultrasound energy to targeted tumor tissue in the prostate. During treatment, the MRI also utilizes special heat-sensitive software to monitor tissue temperature in real time. By precisely targeting the cancerous area plus an additional margin of adjacent tissue to pre-empt cancer spread, the treatment spares surrounding healthy tissue and structure. This means that a patient’s pre-treatment urinary and sexual function can be preserved with a high degree of likelihood.
At all study sites, including ours, the outpatient treatment showed very low impact on patients’ post-op potency and continence. Perhaps more importantly, as expressed by primary Investigator Dr. Behfar Ehdaie, a urologic surgeon at Memorial Sloan Kettering Cancer Center, “Exablate focused ultrasound has been shown to provide effective control of locally confined prostate cancer in select patients based on two-year biopsy outcomes.”[ii] All of us at Sperling Prostate Center are highly confident that the Exablate Prostate system can destroy cancer while maintaining high quality of life and masculinity.
What is 510K clearance?
The FDA has three pathways for bringing a device to market, and the more a device is complex and entails risk while treating potentially lethal disease, the stricter the proving-ground. “Clearance” is a type of certification needed to bring a device to the marketplace. According to the FDA, “A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device…Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims.”
The purpose of the national clinical study involving nine sites was to accumulate the clinical evidence to support the effectiveness and safety of the Exablate Prostate system, which is then submitted for rigorous review by the FDA. Only when the FDA is satisfied that the device performance meets its high standards does the equipment earn premarket approval. This has now been achieved, and Insightec can move forward in bringing this treatment to appropriately selected prostate cancer patients.
The Sperling Prostate Center congratulates Insightec on achieving this milestone. We are grateful to our sponsor for being able to participate in this landmark clinical study, and we look forward with pride to be able to provide this treatment.
NOTE: This content is solely for purposes of information and does not substitute for diagnostic or medical advice. Talk to your doctor if you are experiencing pelvic pain, or have any other health concerns or questions of a personal medical nature.
[i] “Insightec announces FDA clearance for Exablate Prostate to treat prostate tissue.” Press release issued Dec. 1, 2021. https://insightec.com/global/insightec-announces-fda-clearance-for-exablate-prostate/
[ii] Park, Andrea. “FDA clears Insightec’s MRI-guided sound wave technology to treat prostate cancer.” Fierce Biotech, Dec. 3, 2021. https://www.fiercebiotech.com/medtech/fda-clears-insightec-s-mri-guided-sound-wave-technology-to-treat-prostate-cancer