New treatments for wiping out prostate cancer are making their way into hospitals and medical centers in Miami and across the United States.
As of October, the Food and Drug Administration approved high intensity focused ultrasound to treat prostate cancer, nearly two decades after was approved by regulators in Asian and European countries.
The two-hour procedure is minimally invasive, with patients going home the same day, and able to carry on with their normal activities, doctors say. The treatment can be partial, focusing on the damaged tissues, or total if the cancer is affecting the total prostate.
Instead of using radiation, the procedure uses ultrasound energy to destroy the affected tissue. The ultrasound waves target the cancer within the prostate, then the temperature at the top of the probe is raised to around 90 degrees Celsius to destroy the diseased tissue. The tissue outside of the lesion remains unscathed.
Other than skin cancer, prostate cancer is the most common cancer among American men, with about 180,900 new cases each year, according to the American Cancer Society.
Dr. George Suarez, a Miami urologist, has performed more than 2,000 high intensity focused ultrasound procedures in places that had received approval from regulators, including Mexico, Canada and the Dominican Republic. He had been assisting the FDA for several years in designing clinical trials to get the procedure approved in the United States. Suarez says the technology has been around since 1950, but that original applications were for treating brain tumors.
Around the mid-1990s, medical researchers realized that the high-intensity ultrasound could also treat prostate cancer; Suarez learned about it during a conference in Europe in the early 2000s.
“It’s a cancer where existing treatments were somewhat devastating,” he says, “in that it was either radical surgery or eight weeks of radiation. Both of those things resulted in very high incidents of impotence and urinary incontinence. The treatment was worse than the cancer itself.”
In 2003, he ordered the specialized ultrasound machine for a private medical university in the Dominican Republic and began treating patients there. A year later, the original company, now called SonaCare Medical, asked him to get involved with designing clinical trials in the United States. He is co-founder of SonaCare and served on the company’s board before recently resigning to return to his practice.
A 2014 article on the website of the San Francisco Chronicle said Suarez invested $3.3 million in the company.
He told the Chronicle: “I invest in it because I believe in it,” but declined to confirm the figures.
When asked about it last week, Suarez again declined to comment, saying a confidentiality agreement prevented him from discussing his investment in the company.
Meanwhile, the clinical trials finally led the FDA to approve the treatment in October. Suarez treats about 20 patients per month at his practice, International HIFU Center on Sunset Drive. The cost is $25,000 for a one-time treatment. Suarez says the likelihood of needing a second treatment is rare.
Before the FDA approval, insurance companies usually did not cover the cost of the treatment, claiming it was experimental. With the FDA approval, insurance still doesn’t cover it, but it may cover it in the future.
Of the 240,000 men who are diagnosed with prostate cancer annually in the U.S., one-third will choose surgery, one-third will choose radiation and the remaining will choose something else. High-intensity ultrasound can be used to treat radiation failures and second recurrences.
A prostate specific antigen blood test is performed three months after the procedure to check whether the cancer has returned — and then done every four months for five years, and every six months thereafter.
“The bottom line is we have an effective treatment that offers a cure without compromising quality of life and dignity for men who want to preserve their sexual intimacy and their urinary function,” Suarez says. “There’s very little that I can think of that would be worse for a man that’s both impotent and incontinent while trying to survive prostate cancer.”
Carl Sola couldn’t agree more. The South Miami resident is a former patient of Suarez’s who was diagnosed with prostate cancer 12 years ago. He’ll be celebrating his 70th birthday next month.
The day after the procedure, I had dinner with my wife at a restaurant. The next morning I flew home, and on Monday I went to work. Not one drop of blood spilled. Not one drop. It’s not surgery — it’s a procedure.
Carl Sola, who flew to the Dominican Republic to have Dr. George Suarez, a Miami urologist, perform a high intensity focused ultrasound procedure to get rid of his prostate cancer.
At first he didn’t want to have any treatment because he saw how prostate surgery had left his uncle impotent and having to wear adult diapers because of urinary incontinence.
“I said no way am I going to do this. I’ll take my chances.”
His wife told him he didn’t have a right to decide that. He recalls that she asked him: “What about me, the five kids and eight grandkids?”
He had no idea what to do until he came across an article that featured Suarez and the high-intensity ultrasound procedure in the Miami Herald.
“I said I’d better do something before I get hit real hard.”
Sola met with Suarez and soon after booked a flight to the Dominican Republic, where Suarez performed the treatment on him. He paid $20,000 out of pocket, as insurance did not cover the treatment.
“The day after the procedure, I had dinner with my wife at a restaurant. The next morning I flew home, and on Monday I went to work. Not one drop of blood spilled. Not one drop. It’s not surgery — it’s a procedure,” he said.
He recently had another check-up and biopsy on his prostate.
“Clean,” he says, “12 years — clean. I could get an erection. I could hold my urine. I could make love to my wife.”
He says he’s spoken with countless men, advocating this procedure.
“My uncle is six years older than I am,” he says. “We’re like brothers. And it pains me to see the way he has gotten because of the misfortune of not knowing something that wouldn’t have left him in this condition. He’s a shell of the man he used to be. He doesn’t want to leave the house because he has to wear a Pamper.”
The prostate is a small gland, about the size of a walnut. Sola says his was so inflamed it was more than double the normal size.
The prostate is within a capsule. The cancer usually spreads to your lymph nodes if it erupts from its capsule “and then it’s over with,” Sola said.. “You can’t stop it when it gets into your lymph nodes — it could pop out anywhere.”
He said his was caught just in time before the cancer erupted from the capsule.
As of January, the Department of Urology and Sylvester Comprehensive Cancer Center at the University of Miami has been using “Focal Therapy” as their preferred treatment, which is a form of high intensity focused ultrasound. The main difference is that focal therapy won’t work if the entire prostate is affected.
“Because we have now improved at detecting cancer within the prostate, we can use this knowledge to offer focal therapy to only treat the cancer that’s dangerous to the prostate,” said Dr. Dipen Jaysukhial Parekh, chair of the department of urology at UM and director of robotic surgery.
If someone has full blown prostate cancer, Parekh recommends surgery or radiation. He’s treated seven men so far using focal therapy and says a big barrier for patients is paying the $20,000 bill out of pocket since insurance doesn’t cover it, as it’s a new technology.
The American Board of Urology recommends that all men over 50 get screened for prostate cancer, 40 if they have a family history of prostate cancer. If tests come back positive, they should learn as much as they can about their treatment options.
For more information
Dr. George Suarez’s International HIFU Center is located at 9195 Sunset Dr, Suite 110, Miami. Visit www.hifumedicalexpert.com, or call 305-595-0199 or 877-949-5325.