Caution Urged With High Intensity Focused Ultrasound Therapy in Prostate Cancer

The U.S. Food and Drug Administration has approved 2 types of minimally invasive, high intensity focused ultrasound therapy for treating prostate cancer.
The U.S. Food and Drug Administration has approved 2 types of minimally invasive, high intensity focused ultrasound therapy for treating prostate cancer.

The U.S. Food and Drug Administration (FDA) has approved 2 types of minimally invasive, high intensity focused ultrasound (HIFU) therapy for treating prostate cancer. However, this advanced revolutionary technology requires significant urologic training as the technology is complex and caution is being urged.

“Well-selected prostate cancer patients can benefit by maintaining their quality of life and still treating their prostate cancer. However, due to training requirements, I believe that the technology should roll out slowly over 12 to 24 months. Patients should be cautioned that excellent outcomes are only consistently obtained by highly trained users of the technology,” said Stephen Scionti, MD, who is medical director of Vituro Health and founder of the Scionti Prostate Center in Sarasota, FL.

Dr Scionti has been involved in the treatment of approximately 1000 patients over the last decade at the International HIFU Prostate Cancer Centers in the Caribbean and Mexico and as lead proctor for the FDA trials in the United States. He said patients should carefully inquire about the skill level and the experience of the HIFU surgeon and should seek out only highly experienced physicians as this technology rolls out into the US market.

He noted that the FDA has granted regulatory approval to both the Sonablate and the Ablatherm devices via the 510 K pathway. The FDA approved indication is for prostate tissue ablation. “Skilled physicians can employ this technology to ablate prostate tissue in a variety of conditions. However I believe that the technology will be most commonly used to ablate prostate cancer tissue,” Dr Scionti told Cancer Therapy Advisor. “HIFU treatment offers an alternative approach to treating localized prostate cancer. Tissue ablation with HIFU is an option to traditional treatments such as surgery or radiation. The technology allows for focal targeted therapy and allows MRI images to be fused to ultrasound images to allow for targeted ablation in the prostate. The best candidates are men who have localized prostate cancer, a normal sized prostate, and a desire to preserve sexual and urinary function.”

He said HIFU for prostate cancer is not new. The technology has been available in Europe and Asia for more than 15 years. Dr Scionti said long-term studies out beyond 10 years have documented comparable efficacy to other treatments for localized prostate cancer. “The side-effect profiles are favorable with excellent preservation of both urinary and sexual function,” said Dr Scionti.

He said he became an early adopter of HIFU because of the promise of an outpatient, non-invasive procedure where it was possible to customize treatment to the patient through proper understanding of where the tumor was in their prostate. Dr Scionti said HIFU offers an opportunity in properly selected patients to treat cancer with a much reduced side-effect profile that preserves quality of life, including less chance of urinary leakage and sexual issues.

On Dec. 4, 2015, 61-year-old Graceville, FL resident Daniel Hazell was the first patient of Dr Scionti's to be treated with HIFU on American soil. Dr Scionti said what is so remarkable with this approach is that within a week most of the patients won't even notice that they had a procedure done.

The use of HIFU is now offering considerable promise. However, just how widely it is adopted will be determined as more patients are treated and long-term outcomes are validated. Gerald Andriole, MD, who is Chief of Urologic Surgery at Washington University School of Medicine in St. Louis, MO, said ablation of the entire prostate or targeted ablation of only the malignant parts of the prostate, are possible by a variety of technologies.

“HIFU is now an option to consider in addition to cryo-ablation, radiofrequency, microwave, laser, vascular targeted, and electroporation devices among others. The side-effect profile, cost, and the length of the learning curve for effective use of the modality will determine which will be most widely used,” Dr Andriole told Cancer Therapy Advisor. “Most urologists are more conversant with transperineal needle ablation approaches, while HIFU represents a new approach with a completely new learning curve without, at this time, a demonstrated superiority over the other modalities. Time will tell whether it will emerge as a commonly used modality."

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