Exablate MR-guided focused ultrasound launched in US prostate cancer market

The first commercial patient in the United States has been treated for prostate disease with the Exablate Prostate system, according to Insightec, the developer of the technology.¹

The patient received the treatment at Stanford Health Care, which had previously participated in the clinical trials examining the efficacy and safety of Exablate.

The FDA granted Exablate 510K clearance in 2021 for treating prostate tissue with high-intensity magnetic resonance (MR)–guided focused ultrasound (MRgFUS). The 510(k) clearance designation allows a company to market a medical device in the United States if the company can prove that its device is “substantially equivalent” to a device already being legally marketed.²

"We are deeply committed to continuing to transform patient care with minimally invasive, innovative surgical procedures. The Exablate Prostate system will help support a better quality of life for people diagnosed and living with prostate disease," Maurice R. Ferré MD, Insightec CEO and Chairman of the Board of Directors, stated in a news release.

Clinical support

Clinical findings from a phase 2b study (NCT01657942) supporting the use of Exablate MRgFUS in men with intermediate-risk prostate cancer were shared at the 2021 AUA Annual Meeting.³ Overall, the study included 101 men who were treated at 7 academic centers and 1 private practice.

The average patient age was 63 years and 86% of the cohort was White. The median PSA was 5.7 ng/mL. Eighty-four patients had at least clinical stage T1c disease. Seventy-eight percent of patients were in grade group 2 and 22% were in grade group 3.

At 24 months, 88% of men had no evidence of grade group 2 or 3 prostate cancer in the treatment area according to targeted prostate biopsy. Additionally, 60% of men had no evidence of grade group 2 or 3 disease anywhere in the prostate gland, including outside of the treatment area. Serum PSA levels decreased by almost 50% after treatment and stabilized after 6 months.

Erectile function scores were slightly worse at 24 months compared with baseline (HR, -3.5; 95% CI, -5.4 to -1.6). Ten (13%) reported no sexual activity and 81% of patients achieved erections adequate for intercourse. Lower urinary tract symptoms were similar at baseline and 24 months (mean score difference, 1.1; 95% CI, 0.33-1.8).

“Overall, approximately 75% of men were able to achieve functional reactions after treatment at 24 months without starting a new erectile function medication,” Behfar Ehdaie, MD, MS, a urologic surgeon at Memorial Sloan Kettering Cancer Center and Exablate trial PI, said at the time of the AUA presentation of the results. “No patients reported urinary incontinence and the estimated probability of urinary continence over time was excellent.”

References

1. First US commercial patient treated for prostate disease with Insightec incisionless focused ultrasound system. Published online February 3, 2022. Accessed February 3, 2022. https://prn.to/3AV92VY.

2. 510(k) Clearances. US Food and Drug Administration. Accessed August 27, 2021. https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances

3. Ehdaie B, Tempany C, Holland F, et al. MRI-guided focused ultrasound (MRgFUS) focal therapy for intermediate-risk prostate cancer: final results of a phase IIb multicenter study. Presented at: 2021 American Urological Association Annual Meeting; September 10-13, 2021; virtual. Abstract LBA02-12.