Twelve years ago, right after getting a diagnosis of prostate cancer, Carl Sola of Homestead flew with his wife to the Dominican Republic for a treatment he couldn't get in the United States.
His friends warned him not to risk an unproven procedure, one his insurance didn’t cover.
But being a guinea pig appealed to Sola more than the risk of prostate surgery; after a prostatectomy, a relative had been forced to wear diapers.
Sola said that after he finished the painless, bloodless procedure on a Saturday, he and his wife “went out to dinner that night, and flew home Sunday. Monday morning I was up and on the road,” working.
Now, soon to turn 70, he said he’s still cancer-free and all his parts are working fine.
“There’s nothing that can take the place of being able to feel like a total man,” he said.
Now, it’s no longer necessary for Americans like Sola to go overseas for the treatment, which is called high-intensity focused ultrasound or HIFU. The U.S. Food and Drug Administration made HIFU legal for prostate treatment in October.
Since then, at least three Florida urologists who had been doing HIFU offshore are now doing it at outpatient centers in Sarasota and Miami. They say HIFU is in demand even though insurers haven’t learned enough about it yet to give it a billing code, and some patients are paying $20,000 or more.
Urologist George Suarez, who treated Sola and 2,000 others at offshore sites, can now do HIFU at the Miami Sunset Surgery Center. Suarez predicts that HIFU will soon become the standard of care for cancer that is confined to the prostate and has not spread, which describes most cases at time of diagnosis.
“We’re looking at a real game-changer,” Suarez said. “We’re looking at one of the most dramatic and important advances (ever) in urology, if not in medicine.”
Dr. Stephen Scionti, who also has years of experience with HIFU in other countries, now does it at the Sarasota Interventional Radiology Center, along with his colleague Tracy Gapin. Working with a Birmingham company, Vituro Health, Scionti also is developing a training program for urologists who want to learn HIFU.
Still another Sarasota doctor who has been doing HIFU in Cancun, Ronald Wheeler, is now building out space in his office building for the technology.
Whether he will get to use it is an open question: Wheeler faces four state Health Department complaints that say he failed to do a biopsy before treating patients for prostate cancer.
The first step in HIFU is to locate the cancerous area of the prostate, a walnut-sized organ below the bladder where a man’s seminal fluid is made and stored. To detect what's in the gland, a software operator fuses information from an MRI taken earlier with real-time images produced by an ultrasound probe in the man’s rectum. Once a suspicious area is found, a needle is inserted into the middle of it to bring out a bit of tissue for a biopsy.
Dr. Suarez said this “targeted biopsy” is far better than the traditional “blind biopsy,” in which multiple tissue samples are gathered at random in the hope that if cancer is there one of the samples will include it. Federal data show the blind probing misses cancer up to 25 percent of the time.
If the biopsy shows cancer and it is deemed to require treatment rather than just observation, the patient can decide which treatment option he wants, based on his doctor's advice. If he chooses HIFU, a rectal ultrasound device can emit focused waves that heat up the targeted tissue enough to destroy it.
Popular Elsewhere, But Banned In U.S.
The HIFU story reveals an irony of the U.S. health care system. In an effort to protect cancer patients, the FDA wanted manufacturers of HIFU equipment to show that results of the procedure kept patients cancer-free as long as traditional treatments. Yet prostate cancer grows so slowly that it could take a decade or more to show that.
Meanwhile, the HIFU procedure became popular in Europe and Japan, and men there discovered its low risk of side effects compared to the traditional treatments, surgery and radiation. Even with the addition of robotics in surgery and proton beam in radiation, there remained substantial risk of erectile dysfunction and lack of bladder control, studies show.
Rather than hold the devices off the market in this country indefinitely, the FDA decided to reclassify them so that they would need a much shorter approval process. In October, the Sonablate device from SonaCare Medical of Charlotte, N.C., was approved for prostate “ablation,” or tissue destruction, despite objections from two advisory panels that sought more data.
A few weeks after the FDA approval of Sonablate, the agency okayed the Ablatherm device from EDAP, a publicly-traded company based in France.
Dr. Scionti of Sarasota has substantial overseas experience with HIFU. Like Suarez, the Miami urologist, he uses and trains other urologists on the Sonablate machine. Scionti said he is director of clinical education for a separate company, Vituro Health of Birmingham, Alabama. Vituro helps urology groups buy or lease the equipment and get the training.
While Scionti calls HIFU “revolutionary,” he stresses that it requires a great deal of training and experience to do it well.
“We can hurt people just as well with thermal energy as we can with any scalpel, so training becomes critical,” he said.
University of Miami urologist Mark Gonzalgo wrote in the Journal of Urology in October that there are too many unanswered questions on focal therapy, especially in terms of long-term cancer control.
While the treatment sounds like a good idea, Gonzalgo wrote, “for now it appears that the hype associated with focal therapy outweighs the hope.”
Even so, in January the UM became the first site on the East Coast to install an Ablatherm HIFU machine. Dr. Dipen Parekh, head of urologic oncology at Sylvester Comprehensive Cancer Center at UM, said he went to Germany to be trained in its use, and Germans came to the university to proctor his first cases.
Parekh describes focal therapy and HIFU as “attractive” because of the lower risk of side effects. But he said there hasn’t been enough time to determine whether patients remain cancer-free over the long term.
“I’m extremely enthusiastic and optimistic that this will be a very attractive option, but I’m not ready to say at this point that it’s revolutionary,” Parekh said. “I think we still have to wait until the data comes out from this country.”
Parekh said the European data concerned cases in which HIFU destroyed all the tissue in the prostate gland, not just one lesion. But the trend here is to define and target the identified lesion. That could be a problem, critics say, if the gland has more than one lesion, as is often the case.
“Just because something worked in Europe does not necessarily mean it will work to the same extent in the U.S.,” Parekh said.
Insurance Companies May Not Cover Procedure
Two big barriers stand in the way of rapid acceptance of HIFU. Insurers are hanging back on coverage until they learn more about it, which means patients may have to pay $20,000 or more on their own. Also, very few U.S. physicians have expertise in HIFU, since they could only acquire that overseas.
“Trying to teach someone to put away a scalpel and use a computer, it’s a completely different mind-set,” Suarez said.
"HIFU by itself is hugely enormously exciting compared to treatment options,” Suarez said. “But equally as exciting is the fact that we’ve now learned about the importance of MRI-guided biopsy.”
Suarez estimates that two-thirds of the 240,000 prostate cancers diagnosed each year may be good candidates for HIFU, because they have “localized” disease that has not spread to lymph nodes or beyond.
If he’s right, that means the new technology will disrupt the market, attracting patients away from surgery and radiation. Given the heavy investment hospitals have made in robotics and proton beam therapy, it could spark a struggle over market share.
Scionti said he worries that patients will be steered toward one treatment or another based on what a doctor knows how to do or what equipment is readily available.
"This is the confusing thing about prostate cancer," Scionti says. "The same patient, depending on who they see, who they talk to, may end up being treated in really, really different ways."
Parekh at UM, who has done more than 4,000 robotic surgeries, said he doesn’t see HIFU as a threat to his practice.
“I don’t really see doing surgeries as a business, honestly,” he said. “Whatever is best for our patients is what we should be focusing on.”