Men hoping to avoid some of the dreaded side effects of prostate cancer treatment are spending tens of thousands of dollars for a new procedure whose long-term effects are unknown, although insurers, including Medicare, usually will not 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 some patients another option between the active supervision of their cancer signs propagation and those more aggressive measures. Critics, however, say the procedure, leading to some patients for a treatment that is not necessary is oversold.
device manufacturers are busy selling $ 500,000-and-machines in which doctors across the country and offer training courses. Billboards advertise this “new non-invasive treatment for prostate cancer” are emerging, while websites treatment centers promise “a safer method” with benefits such as “without erectile dysfunction without incontinence.”
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But studies show that for patients undergoing treatment of the entire prostate, rates of erectile dysfunction are similar to those of more aggressive treatments, although incontinence rates are lower. When only part of the gland is, proponents compared with a lumpectomy for women with breast cancer side effects are reduced but do not eliminate, according to some studies.
The procedure can range in cost from $ 15,000 to $ 25,000.
HIFU treatment is the latest to raise concerns about whether there should be limits – such as the requirement of monitoring results -. Placed on the new expensive technology, while additional data are gathered
“This is going to join the group of uncertain therapies still available doctors can use, but do not have a clear understanding of which will benefit from a population in the real world,” said Art Sedrakyan, professor of politics health and research at Weill Cornell Medical College in New York. Treatment of prostate cancer has been particularly controversial – and lucrative -. Nicho, because the disease for some men can be slow growing
A number of new non-surgical treatments ” are now also available with sophisticated machines to destroy cancer cells with proton beams or other types of high-dose radiation.
Using HIFU device directs ultrasonic waves for heating prostate tissue to about 195 degrees, the destruction of all or part of the gland. Focusing on what is considered the primary tumor and only eliminate that is a recent trend in cancer treatment prostate . anesthesia is used.
HIFU machines have been used in Europe as in the United States, although national health programs in the UK 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 performed by US doctors who settled in Mexico, the Bahamas or Bermuda.
In the United States, advisory committees of the Food and Drug Administration recommended twice against applications from manufacturers of HIFU devices market as a treatment for prostate cancer, citing insufficient evidence long-term.
However, in October 2015, the FDA approved Charlotte-based device N.C. SonaCare doctor – not for the treatment of prostate cancer per se, but to ablate prostate tissue. The data presented by the company include an analysis of 116 men who had treated his entire prostate and were followed for 12 months. “While the oncological results of this study are inconclusive, the results provide a reasonable assurance of safety and efficacy of the device in the context of ablating prostate tissue,” said FDA in its review .
A device for EDAP based in France, Lyon, won a similar for approval shortly after.
SonaCare said it has sold more than 30 machines in the United States, with medical centers in California, Florida, New York, North Carolina and Texas and who use them. EDAP reported in late August that its earnings HIFU division increased 68 percent in the first six months of 2016.
Researchers say it is too early to say conclusively that the removal of the gland works partially and totally eliminate. There is also a debate on these patients best suited for the treatment :. Low risk, intermediate risk, or those who have failed other types of treatment for prostate cancer
The current and previous studies abroad are available, but they have limitations, including periods fairly short follow-up.
“The largest studies in the world are only four or five years in it,” said Michael Koch, chairman of the department of urology at the Medical Faculty of the University of Indiana, an advocate of HIFU for some patients. “We have no survival data to see if [it] does better than surgery or radiation.”
for more complete answers, some doctors say it is critical to track the results with patient information without identification in a national registry.
it is not a new idea. In fact, some technologies have been granted approval by the FDA or Medicare coverage with a condition that patients should be enrolled in clinical trials or registries.
“short of the FDA telling device makers, ‘Do this,'” establishing a method of comprehensive monitoring is a challenge, said Jim Hu, a urologist and a specialist in robotic surgery at Weill Cornell.
Hu coauthor of role in the Journal of the Medical Association of the United States in July with UCLA Urology residents Sedrakyan and Aaron Laviana, calling a record. Meetings between advocates registration, FDA and device manufacturers are ongoing, but there are still difficulties, Hu said, especially about who would pay for the registration.
“The financial part of this is a somewhat perverse,” he said. “Men are charging $ 25,000 for this, however, no one feels the pressure to demonstrate the effectiveness of treatment.”
A record is currently operating in England that will soon open to US users SonaCare HIFU medical devices. While SonaCare funds the registry, which contains data only on their devices, the company has no control data, said CEO Carol SonaCare brand. His firm also contribute some funds for broader US registry that Hu and his colleagues support, to incorporate the results of other HIFU devices as well.
The evidence gathered could convince Medicare and other insurance that a treatment is effective – and worth covering. However, some doctors may not want insurance companies to cover treatment because when treatment is not covered, cash payments by patients can often overcome what doctors would be paid by insurers. Today, men often pay for themselves, with some success appealing to their insurers to cover part of the costs, Carol said.
insurance coverage for HIFU Ultimately, it will be necessary “to have a powerful as possible,” Carol said. But in the meantime, surgeons using the device with patients who pay cash can not be in a rush for this to change.
“From the economic point of view, [insurance coverage] is a bit of everything,” he said, because coverage usually means lower payments and surgeons “would have to try three or four times more patients to cover the cost of technology. “
While records are useful also have their limitations.
On the one hand, because they are not randomized controlled trials, records are not the best way to compare the treatment of A to B treatment, said Fred Masudi, professor at the Faculty of Medicine of the University of Colorado. However, they may show how the treatments, medications or devices perform in common use.
“It is not a foregone conclusion that the results will be the same [as in clinical trials] why registration programs are so important,” Masudi, who has been involved with other such records said.
Adding a new treatment alternative
Meanwhile, uncertainty about the best treatment options for patients 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 lead to hot flashes, muscle weakness and other problems.
When Cancer is aggressive the benefit of these approaches outweigh these side effects. But for men with lower risk profiles, depending on factors such as age, and the results of tests and biopsies, the option is more difficult . Their tumors may grow so slowly that the cancer would not be fatal for many of these men. Some experts in the health care encourage these patients to opt for “active surveillance”, which means keeping an eye on cancer through regular testing. A study published last month showed that men with early prostate cancer who chose active surveillance had the same small risk of dying from their cancer in the next 10 years as men who had surgery or radiation.
However, some men feel uncomfortable just watching -. And that’s where HIFU could play a role
Patients who have an area in the prostate with a high-grade tumor could choose to treat only the portion with HIFU, Koch of the University of Indiana, who was part of clinical trials device SonaCare he said and accepted company funds.
“If we can treat [that area] therapy, can recover on active surveillance,” Koch said.
Others say that more studies are needed.
With prostate cancer, there may be a dominant tumor, but small cancer cells in the gland elsewhere, said Justin Beckelman, associate professor of radiation oncology at the University of Pennsylvania.
And others point out that patients who choose HIFU need to select physicians with experience and training because the procedure is complex.
“HIFU is a very steep learning curve. Some of the doctors who buy these machines are not ready for it,” said Jim Wickstrom, who had the procedure four years ago in Bermuda and is a great defender. He said patients should do their research and choose only experienced doctors who are willing to show their results data.
Wickstrom chose HIFU after studying its options and looking at data from Europe and Japan. “There is great controversy about any data, but HIFU has been done in other countries for a long time,” Wickstrom, who had his entire gland removed he said.
So far, it has been satisfied: “Everything could not have gone better I left HIFU without pain or incontinence or impotence..”
Kaiser Health News is a national news service health policy that is part of the nonpartisan Henry J. Kaiser Family Foundation.