Focus on Safety If You Are Considering This Treatment
Some men with prostate cancer are planning expensive trips abroad — but not for vacation. They are seeking a high-tech and somewhat controversial treatment for their cancer that promises fewer side effects and a rapid recovery — and, perhaps, higher odds of survival. Not approved here in the US for prostate cancer, the minimally invasive HIFU (High Intensity Focused Ultrasound) uses focused ultrasound beams to heat the prostate to temperatures higher than 80 degrees Celsius, destroying cancer cells. While it sounds promising, this procedure, is not as simple as it first appears to be. There are risks inherent to traveling abroad for medical procedures, in general. And then there’s the treatment itself…
AN UNFINISHED TALE
HIFU treats prostate cancer without destroying surrounding tissue, reducing the likelihood of problems such as incontinence and impotence, which are often associated with other treatments such as surgery, radiation and cryotherapy. This is alluring to the growing number of prostate cancer patients who, expecting to live years beyond their treatment, want to preserve their health and quality of life. Though one in six American men will be diagnosed with the disease in their lifetime, only one in 35 will die from it.
HIFU can be an excellent technology when used “in the right hands among appropriate patients,” I was told by Thomas Gardner, MD, associate professor of urology at Indiana University School of Medicine in Indianapolis. He is a researcher involved in clinical trials of Sonablate HIFU here in the US. Phase I/II trial results, published in the Journal of Urology in December 2007, were encouraging: “High-intensity focused ultrasound in patients with previously untreated prostate cancer is generally well tolerated and it has the potential to completely ablate the prostate gland,” their study concluded, noting “with further refinement of the optimal treatment dose and technique, this technology has the potential to be an effective form of therapy for localized prostate cancer.” However, research efforts have been partly delayed for the Phase III trial due to recruitment and funding problems.
Of course, given risks of the current treatment options, such as surgery, many men are still anxious to try what appears to be a better, more tolerable and more effective method. Though there are claims of fewer side effects compared with other prostate cancer treatments, Dr. Gardner said this has yet to be proven — and the same holds true for HIFU’s long-term cure rates. No published US clinical trial data comparing long-term cure rates of HIFU with other standard prostate cancer therapies is available.
HOW HIFU WORKS
There are two types of HIFU technologies, neither approved in the US. Both use a transrectal probe to deliver ultrasound energy directly to the prostate without causing damage to areas outside of the gland. “This technology can spare nerves, whereas other prostate cancer treatments often cannot,” Dr. Gardner explained.
- Sonablate. This technology is available in Mexico as well as Canada, the Dominican Republic, Costa Rica, Argentina, Japan, Europe and South Africa. The equipment uses a split-beam technology allowing the doctor to visualize and treat the cancerous area. It has four different probes of varying focal lengths that can all be used sequentially in one treatment session. “The Sonablate is a more controllable device because it can provide adjustable focused ultrasound,” explained Dr. Gardner. HIFU with Sonablate is an outpatient procedure usually lasting between two and three hours, depending on the size of the prostate. Since it involves no incision, cutting or radiation, it can easily be repeated if necessary. It can also be used as a salvage therapy if there is a recurrence of cancer in the event other treatments fail.
- Ablatherm. In comparison, this is a device produced by the French company EDAP TMS and is approved for use in Canada, Europe, Russia, South Korea and Australia. It employs just a single focal zone length and does not allow for monitoring during treatment. It’s more of a “‘one size fits all’ device because it only delivers focused ultrasound at one distance,” says Dr. Gardner. Also, Ablatherm sometimes requires a pre-surgical procedure, called a transurethral resection of the prostate (TURP) in large prostates, while the Sonablate does not.
THE PRICE IS ONE BIG PROBLEM…
Beyond a lack of data, the real downside of HIFU for consumers is cost. Treatment can range between $10,000 and $25,000, depending on where the patient is treated. Insurance companies rarely pick up the tab. It’s perhaps understandable that some patients, especially those with deep pockets, might waive those concerns, but the problem with seeking HIFU treatment overseas is that some clinics offering the therapy may be largely motivated by big profits, says Dr. Gardner, not quality patient care. The results can be devastating. Many off-shore sites seek to treat as many patients as quickly as they can… potentially leaving a significant percentage under-treated. Due to the size of the prostate and amount of time it takes to treat it effectively, two or three HIFU treatments may be required to eradicate the cancer — and patients are not necessarily told this before they begin.
For prostate cancer patients who are nonetheless interested in pursuing HIFU, how can they protect themselves?
First, says Dr. Gardner, is to find out whether or not it’s a good therapy for their cancer. HIFU therapy is reasonable for patients who meet all these criteria:
- Early stage (T1 or T2) cancer with localized (organ-confined) tumors
- A Gleason score (a grading score of the prostate tumor that indicates how likely the tumor is to spread) of less than or equal to 6
- A PSA level less than 10 ng/mL
- Have had a recent (within six months) prostate biopsy that is positive for cancer cells.
- A prostate volume of less than 40 cc.
Be sure to carefully investigate the quality of physicians and facilities at the HIFU clinic you are considering. Dr. Gardner has concerns about the treatments in places such as Mexico or the Dominican Republic, where he believes there’s not as much control over the quality of care — a problem that gets truly dangerous when coupled with a financial incentive in some clinics to treat as many patients as possible. Also, while there is no data demonstrating Sonablate to be superior to Ablatherm, Dr. Gardner believes its flexibility makes it easier to use. How to reconcile the choice? He says wait for a clinical trial or take your chances.
However, Dr. Gardner urges caution. “Patients should be very careful,” he said. “There are several established techniques, such as surgery, radiation and cryotherapy, available in the US for the treatment of localized prostate cancer. While these do have some risk to future male function, unlike HIFU, they are generally conducted in approved hospital or surgical settings. Here in the US, it is only safe to have unapproved techniques such as HIFU in a clinical trial setting.”
Do not sign up for treatment unless you have thoroughly discussed your case and your eligibility with your doctor, he cautions.