Ultrasound probe device and beam

High Intensity Focused Ultrasound (HIFU)

What is HIFU?

High-Intensity Focused Ultrasound (HIFU) is a treatment for prostate cancer that is widely still considered experimental. In 2015 the FDA approved the use of HIFU for “prostate ablation” in the U.S. This means it was approved for prostate tissue removal (such as for benign prostatic hyperplasia, or BPH) and not specifically for prostate cancer treatment.

Beyond the primary purpose for BPH, in the U.S. HIFU is typically used only for localized prostate cancer (cancer that hasn’t spread outside the prostate). Because of this, it is best suited for men who are in the early stages of prostate cancer. In more advanced stages when the cancer has spread beyond the prostate, HIFU therapy is not effective.

What is focal therapy?

HIFU is a focal therapy technique that targets a specific area of the prostate rather than the whole gland. Other types of focal therapy include cryotherapy. This is why it is used only for localized prostate cancer.

Prostate cancer is considered a “multifocal disease,” meaning that there is not a single location in the prostate gland where cancer cells are always found to be present when the cancer is diagnosed through biopsy. Research has shown that pathological analyses of radical prostatectomy specimens have demonstrated that multifocal tumors are present in nearly 90% of cases and an average of 2 to 4 tumors are found in each patient.1

How does HIFU work?

In the U.S., focused ultrasound has already been available to treat uterine fibroids and relieve pain from bone metastases. In addition, there is a growing number of clinical trials in various stages of research and development around the world, including Parkinson’s disease, essential tremor, breast cancer, pancreatic cancer, and brain tumors.

High-intensity sound waves target the prostate cancer tumor through an ultrasound probe inserted into the rectum. The healthcare provider/surgeon controls the HIFU probe with a robotic arm that is calibrated to move in millimeters. The probe heats to 80 Celsius (176 degrees Fahrenheit) in order to kill the cancerous tissue.

HIFU is used for:

  • Men with localized prostate cancer
  • Men with benign prostatic hyperplasia (BPH)
  • Men with Gleason scores 6 and below

There are several factors to consider and discuss with your healthcare provier before deciding on HIFU as a treatment option. These include:

  • HIFU is a non-invasive procedure
  • Surrounding healthy tissue is not damaged by HIFU treatment

However, there are also potential side effects to consider and discuss with your healthcare provider before HIFU treatment:

Limitations of this treatment option

Because of the fairly recent FDA approval, not all hospitals offer this treatment. While the treatment procedure itself does not take very long, you may need to travel to find a specialist who performs HIFU therapy.

HIFU is a relatively new treatment option in the U.S. but it has been widely used in Europe for more than 15 years with positive results. HIFU has an 86 percent, 5-year success rate in Europe for prostate cancer in the early stage. These data also show that about 80 percent of men with prostate cancer treated with HIFU have remained free of cancer for seven years.2

One issue that makes this prostate cancer treatment hard to compare with other treatments is the lack of studies that show the effectiveness of focal therapy for long-term cancer control in comparison with radical prostatectomy or radiation therapy.

Another limitation of current research and European data is that the risk of developing secondary prostate cancer lesions after HIFU has not been measured through clinical trials. This is primarily because HIFU may not be able to reach tumors that are not localized to the prostate gland.

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