When Dr. Michael Lazar makes weekend trips to Puerto Vallarta, Mexico, it’s for business — to use a high-tech device to treat men with prostate cancer.
Lazar, a Santa Rosa urologist for 30 years, is the only Northern California physician regularly treating patients with high-intensity focused ultrasound, known as HIFU, which is currently not approved for use in the United States.
But HIFU, used for a decade or more in other countries, is “hands-down,” Lazar said, the best treatment for prostate cancer, the most non-skin common cancer in men and second only to lung cancer in deaths.
HIFU is the only non-invasive and radiation-free treatment for the disease, which was diagnosed in nearly 240,000 American men last year and caused almost 30,000 deaths, Lazar said.
The process uses an “acoustic scalpel” of high-intensity sound waves focused to a tiny point and heated to 200 degrees Fahrenheit, literally burning away cancerous growth and leaving all other tissues untouched.
Lazar, who’s performed about 100 HIFU procedures since 2007, said the success rate — in terms of keeping patients cancer-free — is comparable to the conventional treatments: surgery, radiation or cryotherapy.
The payoff, he said, is that HIFU is “substantially less likely” to result in impotence or incontinence, the major risks of the other treatments.
Radiation, in addition, is a prolonged, tiring treatment that also risks cancer due to chromosome mutation and internal burns.
HIFU procedures are relatively quick, and patients, following recovery from anesthesia, experience little pain or bleeding because the ultrasound waves seal off nerves and blood vessels, Lazar said.
“You’re on your feet, you can go out and eat” the evening after surgery, he said.
Temple Smith of Cloverdale had a HIFU procedure done by Lazar more than five years ago and said he remains cancer-free. Smith’s uncle died of prostate cancer and his brother, who had surgery to remove his prostate, became incontinent.
“If you have prostate cancer and the resources to get the HIFU treatment, get it done,” Smith said.
Another patient, Harlow Plimpton of San Francisco, had the treatment in 2011 and experienced no side-effects.
“Since then I’ve been looking for a downside, but frankly I haven’t found any,” Plimpton said.
Cost is the rub, Lazar said.
HIFU costs $25,000 and may or may not be covered by insurance. “It’s a leap of faith,” Lazar said, explaining that patients pay for the procedure and take the chance it will be covered.
Many of his patients obtain a home equity loan to pay for the treatment, he said.
HIFU has been performed for years in Japan, Europe and Canada, and is approved for use in more than 30 countries. Closest to home, it is available in Puerto Vallarta and Cancun in Mexico, as well as Nassau, Bermuda, Toronto and Montreal.
Hospital San Javier in Puerto Vallarta, where Lazar works seven or eight weekends year, is accredited by the Joint Commission, which accredits U.S. hospitals.
In the U.S., HIFU is pending approval by the Food and Drug Administration, which has accepted the results of a clinical trial involving 100 American patients whose prostate cancer returned following radiation treatment.
HIFU had a 70 percent success rate in the trial, said Lazar, who was a proctor during the trial.
Dr. Stephen Scionti, a urologist and prostate cancer expert in Framingham, Mass., said that HIFU, under the right conditions, “offers the best opportunity for excellent results” in treating prostate cancer.
HIFU also has potential for treating cancers of the kidney, uterus, bladder and liver, Scionti said. It has the potential to treat breast cancer, Lazar said.
The FDA’s decision on HIFU is expected within year. Approval in the U.S. is a prolonged, expensive process, and the agency will not accept results from other countries, Lazar said.