FDA Gives Green Light to Focused Ultrasound for Ablation of Prostate Cancer

Focused ultrasound uses real-time image guidance allowing the physician to direct a focused beam of ultrasound energy to a selected volume in the patient’s prostate gland.

The energy heats the targeted tissue at the focal point and thermally coagulates the targeted cells within seconds. This process is repeated until the selected volume or the entire gland is destroyed.

Focused ultrasound treatments are performed with no incisions, leading to few complications and minimal discomfort, enabling patients to return to daily activities rapidly. Because there is no radiation involved, the procedure can be repeated, if necessary.

“The best candidates for this treatment are men with intermediate-risk prostate cancer (prostate specific antigen<10; Gleason 7 or less; digital rectal exam: negative or small nodule) with cancer only on one side. Concern is overtreatment of indolent cancers (low or very low risk cancers by National Comprehensive Cancer Network criteria), which are currently managed by active surveillance,” said Julio Pow-Sang, MD, chair of the Genitourinary Oncology Program at Moffitt Cancer Center, Tampa, FL.

He said while this new technology may be helpful, he is concerned about how it will be used and in which patients. In addition, he noted that the studies have not confirmed that it can help prostate-related mortality.

“The procedure should be less morbid than surgery or radiation therapy,” Dr. Pow-Sang told Cancer Therapy Advisor.

“There are no long-term (>10 years) data for focal therapy as compared to established procedures for clinically significant cancer. So, the question remains regarding impacting cancer-specific mortality or overall mortality.”

There are a growing number of clinical applications of focused ultrasound in various stages of research and development around the world, including in Parkinson’s disease, essential tremor, breast cancer, pancreatic cancer, and brain tumors.²

References

1. Department of Health & Human Services. DEN150011 Sonablate® 450 evaluation of automatic class III designation – de novo request regulation number: 21 CFR 876.4340 regulation name: high intensity ultrasound system for prostate tissue ablation regulatory classification: class II product code: PLP dated: March 23, 2015 Received: March 24, 2015 [letter]. http://www.accessdata.fda.gov/cdrh_docs/pdf15/DEN150011.pdf. Published October 9, 2015. Accessed October 19, 2015.
2. Focused Ultrasound Foundation. FDA approves first focused ultrasound system for treating the prostate. http://www.fusfoundation.org/news/129-press-room/1668-fda-approves-first-focused-ultrasound-system-for-treating-the-prostate. Published October 13, 2015. Accessed October 19, 2015.