News Flash: FDA Approves First FUS System for Prostate

Published: 13 October 2015

FDA Approves First Focused Ultrasound System for Prostate

The US Food and Drug Administration has approved SonaCare Medical’s Sonablate 450 focused ultrasound system for the ablation of prostate tissue. Focused ultrasound enables treatment of organ-confined prostate disease while preserving surrounding healthy tissue, without radiation or surgery.

“For men with conditions like prostate cancer, the option of a non-invasive procedure that can selectively target and treat diseased tissue is very appealing,” says Neal Kassell, MD, Chairman of the Focused Ultrasound Foundation. “American men have been traveling overseas for focused ultrasound treatment for prostate diseases for years, and we are pleased that they will now have access to this innovative treatment at leading centers in the United States.”

More than 50,000 men around the world have been treated with focused ultrasound for prostate cancer. It is the leading clinical application of the technology -- more than 50% of the patients who have undergone focused ultrasound around the globe have had prostate disease treated.

The technology has been successfully used to treat a wide variety of diagnoses, including benign prostatic hyperplasia (BPH), partial gland cancer, localized whole-gland prostate cancer, and recurrent prostate cancer.

“I believe that we are at a pivotal point in prostate care,” said Michael Koch, MD, Sonablate trial investigator and Chairman of the Department of Urology at Indiana University. “Simultaneous advances in imaging, fusion technologies, and now more focused therapies are going to allow us to precisely diagnose prostate conditions and ablate these targeted areas rather than perform whole gland prostate surgery, which carries a significant burden on quality of life. Focused ultrasound will become the work-horse of subtotal prostate therapy.”

In addition to Sonablate, EDAP’s Ablatherm focused ultrasound system for treating the prostate is under FDA review and may be approved soon. Focused ultrasound devices have been cleared to treat the prostate in more than 40 countries since the first approval in 2000. Several systems for focused ultrasound ablation of prostate tissue are commercially available or being researched in other geographic regions with differing guidance methods (ultrasound vs. magnetic resonance imaging) and approach (transrectal or transurethral).

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About Focused Ultrasound
Focused ultrasound is a non-invasive, radiation-free method to treat localized prostate cancer. Using real-time image guidance, the physician directs 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.

About Prostate Cancer
Prostate cancer is the most common type of cancer in US men, with around 186,000 new cases and 28,600 deaths reported each year. It is the second leading cause of cancer death in American men, behind lung cancer.

Prostate cancer originates from the epithelial cells within the gland. Screening exams for prostate cancer include digital rectal examination and a blood test to measure prostate-specific antigen (PSA) levels. A physician can only make a definitive prostate cancer diagnosis based on biopsy results.

Other Prostate Cancer Treatments
Because prostate cancer often grows very slowly, some men (especially those with low grade cancer, or those who are older or have other serious health problems) may never need treatment for their prostate cancer. Instead, their doctors may recommend actively monitoring the disease. For patients requiring treatment, common options for men with localized prostate cancer include radical prostatectomy and radiation therapy. Less common approaches include androgen deprivation therapy and cryoablation. The choice of therapy depends on a number of factors, including cancer stage, presence of comorbidities, and patient preferences.

Depending on the therapy, the precision of the procedure and approach, prostate cancer treatment can be associated with side effects including urinary dysfunction, bowel dysfunction and erectile dysfunction. These effects may range in severity and may diminish over time after treatment.