Recent FDA Approval Allows Local Patients Access to New Prostate Cancer Treatment.
From left to right, John Rewcastle, from EDAP, HIFU pioneer Stefan Thüroff, MD, as well as Clifford D. Gluck, MD, and James Lin, MD, of Greater Boston Urology
For many years, and for the vast majority of patients, there traditionally have been two main approaches to the treatment of prostate cancer: surgery or radiation. Both, unfortunately, come with potential side effects, incontinence and erectile dysfunction being two of particular concern. Another treatment option that minimizes these side effects was recently approved by the FDA, and Greater Boston Urology has become the first practice in the area to offer it to local patients.
High-intensity focal ultrasound (HIFU) ablation of the prostate has been used for many years outside the United States, and more than 50,000 patients have already received the treatment globally. Physicians at Greater Boston Urology have performed the procedure many times before, but only on patients who were able to travel outside the United States for their care.
“HIFU has been around for the past 20 years in Europe, the original technology having been developed in Germany and France.” says Clifford Gluck, MD, FACS, of Greater Boston Urology. “We had been offering it in our practice for approximately five years but we had to perform the procedures in Bermuda or the Bahamas. Then in October 2015, the FDA approved HIFU for use in the United States so we are now able to bring it here.”
HIFU grew out of the idea of lithotripsy, the very common process of using extracorporeal shock waves to break down kidney stones. Taking the same idea of using energy to change tissue, it was discovered that physicians could use several ultrasound waves at low intensity, which individually could pass through the body without doing any harm, and focus them onto a precise area in order to burn a piece of tissue. The process is similar to using a magnifying glass to focus sunlight.
There are two different systems of HIFU. The one available at Greater Boston Urology is Ablatherm, which is a robotically controlled system developed by the French company EDAP TMS.
Example of medical professionals treating a patient during a typical HIFU procedure
Advantages of HIFU
“The great advantage of HIFU is that you can do this very accurately,” Dr. Gluck explains. “You can create a lesion which we know is exactly 1.7 millimeters in width and 20 to 24 millimeters in length. We can then adjust as necessary and very carefully ablate the prostate tissue using that energy. By ablating the tissue, we destroy the protein, and that allows healing to occur.”
HIFU offers several advantages over surgical treatment options, according to James Lin, MD, a board-certified urologist and colleague of Dr. Gluck’s at Greater Boston Urology.
“With surgery, we are changing the anatomy by taking the prostate out,” he says. “It’s an invasive procedure and, therefore, has a higher risk of causing erectile dysfunction or incontinence. HIFU is a minimally invasive outpatient procedure. Instead of removing the prostate, we are using high-intensity focal ultrasound to elevate the temperature to over 100 degrees Celsius to ablate the prostate. It kills the cancer cells and the prostate cells. We have an excellent chance of creating very small margins between treatment areas — hot and cold, so to speak — which translates into an excellent chance of preserving nerves and the structures that control urination.”
Similarly, HIFU offers superior outcomes to the radiation therapies that have traditionally been the primary treatment alternative for prostate cancer.
“HIFU causes the tissue damage up front, and healing occurs afterwards,” Dr. Gluck explains. “With radiation, the tissue damage occurs and continues for the rest of the patient’s life, whether that is radiation cystitis, radiation proctitis, or fistula, or some other malady.
“Another significant advantage with HIFU is that it can be repeated. And if a patient has a cancer that is localized to one side of the prostate or another, which is actually quite common, we can treat only the cancerous side and spare the healthy side, therefore sparing the patient’s continence and erectile function.”
Dr. Gluck in consultation with a prospective HIFU patient
According to Dr. Lin, almost all prostate cancer patients can be treated using HIFU.
“There isn’t an age limit on HIFU,” he says, “but there is a prostate size limit. If a patient has a prostate that is larger than 40 grams, we can first reduce the size with a conventional transurethral resection of the prostate, or TURP. That helps to downsize prostate and open up the urethra to minimize issues with urination afterwards.”
“HIFU can also be used to treat radiation failures,” Dr. Gluck says. “Patients who have failed either external beam radiation or interstitial radiation with brachytherapy can get a second chance with HIFU. It can also be used for patients who failed cryoablation of the prostate and for any patient de novo who has a rectum through which we’re able to access the prostate.”
Patients who may not be ideal candidates include those who have had rectal cancer, or rectal stenosis or abnormalities, some patients with higher-grade cancers, patients who do not have a rectum, or patients who have a severe allergy to latex.
Although Greater Boston Urology has offices across eastern Massachusetts, Drs. Gluck and Lin perform HIFU procedures at the Eastern Massachusetts Surgery Center in Norwood. Because it is a minimally invasive outpatient procedure, patients can expect to be home the same day of a procedure, which, depending on the size of the prostate, can take anywhere from an hour and a half to two hours to complete.
“Patients are under general anesthesia and are comfortable,” Dr. Lin says. “There are no incisions. They do go home with a Foley catheter to help drain urine. That catheter can usually be removed within a few days so that patients can urinate normally. The next day they can be up and around and do all normal activities. There are no restrictions.”
HIFU is not currently covered under most insurance plans and, with a $25,000 price tag, it may be out of the financial reach of most patients. The doctors at Greater Boston Urology are hopeful, though, that FDA approval will quickly lead to coverage through Medicare, which in turn often leads to most major insurance companies covering it.
And that’s a good thing, as HIFU seemingly has the potential to become the go-to treatment for prostate cancer.
For more information about HIFU, or to refer a patient, please visit www.greaterbostonurology.com or call 617-696-1826.