Men hoping to avoid some of the dreaded side effects of prostate cancer treatment are shelling out tens of thousands of dollars for a new procedure whose long-term effects are unknown, even though insurers, including Medicare, generally won’t pay for it.
Proponents say high-intensity focused ultrasound (HIFU) has comparable short-term results and may have fewer side effects than surgery or radiation, while giving some patients another option between actively monitoring their cancer for signs of spread and those more aggressive steps. Critics, however, say the procedure is being oversold, leading some patients to get a treatment they don’t need.
Device makers are busy selling the $500,000-and-up machines to doctors around the country and offering training courses. Billboards advertising this “new noninvasive treatment for prostate cancer” are springing up, while treatment center websites promise “a safer method” with benefits such as “no erectile dysfunction and no incontinence.”
But studies show that for patients undergoing treatment of the whole prostate, rates of erectile dysfunction are similar to those for more aggressive treatments, although incontinence rates are lower. When only part of the gland is treated, which proponents liken to a lumpectomy for women with breast cancer, side effects are reduced, but not eliminated, according to some studies.
The procedure can range in cost from $15,000 to $25,000.
HIFU is the latest treatment to prompt concerns over whether there should be limits — such as requiring tracking of results — placed on expensive new technology while additional data is gathered.
“This is going to join the group of uncertain-yet-available therapies that physicians can use, yet we have no clear understanding of who will benefit in a real world population,” said Art Sedrakyan, a professor of health care policy and research at Weill Cornell Medicine in New York. The treatment of prostate cancer has been a particularly controversial — and lucrative – niche, because the disease for some men can be slow-growing.
A host of new “nonsurgical’ treatments are now also available using sophisticated machines to destroy cancer cells with proton beams or other types of high-dose radiation.
Using HIFU, a device directs ultrasound waves to heat prostate tissue to about 195 degrees, destroying all or portions of the gland. Focusing on what is considered the main tumor and only removing that is a newer trend in prostate cancer treatment. Anesthesia is used.
HIFU machines have been used in Europe longer than in the United States, although national health programs in the United Kingdom and elsewhere limit coverage to patients enrolled in clinical trials or other research programs. While the devices are approved in Canada, the national health program does not pay for it. Until recently, some men in this country traveled to have the procedure done by US doctors who set up shop in Mexico, the Bahamas, or Bermuda.
In the United States, advisory committees to the Food and Drug Administration twice recommended against applications from manufacturers to market HIFU devices as a treatment for prostate cancer, citing an insufficient amount of long-term evidence.
But in October 2015, the FDA approved Charlotte, N.C.-based SonaCare Medical’s device — not for the treatment of prostate cancer per se, but for the ablation of prostate tissue. Data submitted by the company included an analysis of 116 men who had their entire prostate treated and were followed for 12 months. “While the oncological outcomes from this study are inconclusive, the results provide reasonable assurance of safety and effectiveness of the device in the context of prostate tissue ablation,” the FDA said in its review.
A device by Lyon, France-based EDAP gained a similar approval shortly thereafter.
SonaCare said it has sold more than 30 of the machines in the United States, with medical centers in California, Florida, New York, North Carolina, and Texas already using them. EDAP reported in late August that earnings from its HIFU division rose 68 percent in the first six months of 2016.
Researchers say it’s too soon to state conclusively that partially ablating the gland works as well as totally removing it. There is also debate over the type of patients best suited for the treatment: low risk, intermediate risk, or those who have failed other types of prostate cancer treatment.
Ongoing and previous studies from abroad are available, but have limitations, including fairly short follow-up periods.
“The biggest studies in the world are only four or five years into it,” said Michael Koch, chairman of the urology department at Indiana University School of Medicine, a proponent of HIFU for some patients. “We don’t have survival data to see if [it] does better than surgery or radiation.”
To get more complete answers, some physicians say it’s critical to track outcomes with de-identified patient information in a nationwide registry.
It’s not a new idea. Indeed, some technologies have been granted approval by the FDA or coverage by Medicare with a condition that patients must be enrolled in clinical trials or registries.
“Short of the FDA saying to device makers, ‘You need to do this’,” establishing a comprehensive tracking method is challenging, said Jim Hu, a urologist and a robotic surgery specialist at Weill Cornell.
Hu coauthored a paper in the Journal of the American Medical Association in July with Sedrakyan and UCLA urology resident Aaron Laviana, calling for a registry. Meetings between registry proponents, the FDA, and the device makers are ongoing, but challenges remain, Hu said, particularly around who would pay for such a registry.
“The financial piece of this is somewhat perverse,” he said. “Men are being charged $25,000 for this, yet no one feels pressure to demonstrate the efficacy of the treatment.”
A registry is currently operating in England that will soon open to US users of SonaCare Medical’s HIFU devices. While SonaCare funds the registry, which contains data only on its devices, the firm does not have control of the data, said SonaCare CEO Mark Carol. His firm will also contribute some funding to a broader US registry that Hu and his coauthors support, which would incorporate results from other HIFU devices, as well.
The evidence gathered could convince Medicare and other insurers that a treatment is valuable — and worth covering. But some practitioners may not want insurers to cover the treatment because when a treatment isn’t covered, cash payments by patients can often exceed what physicians would be paid by insurers. Currently, men usually pay for it themselves, with some successfully appealing to their insurers to cover part of the cost, said Carol.
Ultimately, insurance coverage will be needed for HIFU “to have as large a reach as possible,” said Carol. But in the meantime, surgeons using the device with cash-paying patients may not be in a rush for that to change.
“From an economic point of view, [insurance coverage] is a mixed bag” he said, because coverage usually means lower payments and surgeons would “have to treat three or four times as many patients to cover the cost of the technology.”
While registries are useful they also have limitations.
For one thing, because they are not randomly controlled trials, registries aren’t the best way to compare treatment A to treatment B, said Fred Masoudi, a professor at the University of Colorado’s medical school. But they can show how treatments, drugs, or devices perform in common use.
“It’s not a foregone conclusion that results will be the same [as in clinical trials], which is why registry programs are so important,” said Masoudi, who has been involved with other such registries.
Adding a new treatment alternative
Meanwhile, uncertainty regarding patients’ best treatment options has created an opportunity for HIFU.
Surgery and radiation can pose problems such as incontinence or impotence; while hormonal treatments also cause impotence and can also result in hot flashes, muscle weakness, and other problems.
When the cancer is aggressive, the benefit of these approaches outweigh such side effects. But for men with lower-risk profiles, based on factors such as age, and results of tests and biopsies, the choice is more difficult. Their tumors may grow so slowly that the cancer wouldn’t be fatal for many of these men. Some health care experts encourage these patients to opt for “active surveillance,” which means keeping an eye on the cancer through regular testing. A study published last month showed that men with early prostate cancer who chose active monitoring had the same small risk of dying of their cancer over the next 10 years as men who underwent surgery or radiation.
But some men are uncomfortable just watching — and that’s where HIFU could play a role.
Patients who have an area in the prostate with a higher-grade tumor could choose to treat just that portion with HIFU, said Indiana University’s Koch, who was part of the clinical trials of SonaCare’s device and has accepted funding from the company.
“If we can treat [that area] with therapy, we can get them back on active surveillance,” said Koch.
Others say more study is needed.
With prostate cancer, there may be a dominant tumor but small cancer cells elsewhere in the gland, said Justin Beckelman, associate professor of radiation oncology at the University of Pennsylvania.
Still others note that patients who choose HIFU need to select physicians with lots of experience and training because the procedure is complex.
“HIFU is a steep learning curve. Some of the doctors buying these machines are not ready for it,” said Jim Wickstrom, who had the procedure four years ago in Bermuda and is a big proponent. He said patients should do their research and choose only very experienced physicians who are willing to show their outcome data.
Wickstrom chose HIFU after studying his options and looking at data from Europe and Japan. “There’s a lot of controversy about no data, but HIFU has been done in other countries for a long time,” said Wickstrom, who had his whole gland ablated.
So far, he’s been pleased: “Everything could not have gone better. I came out of HIFU with no pain or incontinence or impotence.”
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.