NEW YORK – A Miami physician who has developed a Federal Drug Administration-approved treatment for prostate cancer that does not require surgery, radiation therapy or chemotherapy, is now researching ways to use the technology to treat even the most advanced stages of the disease.
As WND reported last month, the High-Intensity Focused Ultrasound treatment, or HIFU, directs acoustic energy into the body and destroys cancerous cells in the prostate.
George M. Suarez, M.D., F.A.C.S., F.A.A.P., a board-certified urologist and a former faculty member of the University of Miami Department of Urology, has worked since 2001 to develop the HIFU technology. He finally received FDA official approval to use HIFU as a medical treatment for prostate cancer on Oct. 9, 2015, after spending more than $250 million to complete clinical trials.
“The treatments that are available today for advanced stage prostate cancer are mostly palliative,” Suarez told WND in a telephone interview. “Even with surgery, you can have a PSA reoccurrence of the cancer.”
Prostate-specific antigen, or PSA, is a protein produced by prostate cells. Elevated levels of PSA, measured by blood tests, is typically associated with an increased risk of prostate cancer.
Many of the existing traditional therapies for prostate cancer come with associated risks that patients must take into account.
“The problem with radiation therapy is that you can only have radiation therapy one time in your life,” he pointed out. “Radiation therapy increases the chances of getting a second cancer, including leukemia, bladder cancer and rectal cancer. With hormone therapy there is an increased probability of accelerating heart disease, with a heightened risk of heart attacks, as well as the risk of accelerating diabetes or osteoporosis, a weakening of the bones.”
Today, Suarez, who has now treated several thousand patients over the past 13 years, is widely known as the pioneering urologist who spearheaded the HIFU clinical trials with the FDA. He is acknowledged as the foremost expert in the United States on the HIFU procedure applied to the treatment of prostate cancer.
“It’s an amazing technology in that, unlike surgery or radiation, with HIFU a doctor can now determine the targeted cancer area that requires treatment and visualize the vital structures necessary for preserving quality of life,” said Suarez.
“This means we can work around and maintain the neurovascular bundles that are responsible for preserving sexual potency in a man, or the external sphincter that preserves urinary continence – extremely life-altering side effects that can compromise a man’s quality of life,” he explained.
The challenge Suarez faces today is that while his HIFU treatments are highly effective at eliminating isolated groups of cancerous prostate cells, the treatment does not as immediately apply to treating metastic prostate cancer.
Metastic prostate cancer develops when cancer cells break away from a tumor in the prostate gland and travel through the blood or the lymphatic system.
There is no cure for prostate cancer that has metastasized, and the survival rates under traditional therapies are not encouraging. Patients with metastic prostate cancer have only a 56 percent chance of surviving five
years. But if the metastic prostate cancer includes bone metastasis, the chances of a five-year survival drops to only 3 percent.
Treatment for terminally ill
Suarez explained he has learned how to adapt HIFU therapy to treat advanced-stage prostate cancer.
“When you perform HIFU, there is a release of proteins called heat-shock proteins, much as if you took a piece of fruit, like a plum, and you squeeze it until the fruit inside pops out,” he explained.
“The fruit that squeezes out is the heat-shock protein,” he continued. “We have learned to take these cells out of the body and manipulate them to increase their immune response, such that when these post-HIFU cells are injected back into the body, they now recognize and attack cancer cells as foreign body.”
Suarez explained the technique is similar to experimental immunotherapy treatments that have shown remarkable results. Some 94 percent of terminal leukemia patients who have been told they have just months to live go into remission.
The experimental therapy removes from the body “white blood T-cells” and genetically treats them. When the cells are injected back into the body, they become highly effective at targeting and destroying the cancer.
He has worked with cellular biologists to develop a unique process that has produced promising results.
Before HIFU received FDA approval, Suarez obtained a favorable response in 60 percent of the 20 patients he treated outside of the United States, working with patients considered terminally ill because their prostate cancer was continuing to advance after having failed all other treatments including in some cases, a combination of surgery, radiation and hormone therapy.
“By virtue of the fact that prostate cancer in the Caribbean is typically diagnosed at advanced stages, and patients have limited resources for treatment, we have been able to provide the most advanced prostate cancer immunotherapy treatments to them at no cost,” said Suarez.
“And now that HIFU is an FDA-approved protocol, I plan on beginning a study by the end of April, working again with prostate cancer patients considered terminally ill because they have exhausted all of the traditional medical procedures without stopping the disease.”
Fully funded trial
Suarez, along with longtime associate Dr. Rafael Estrella, will spearhead the trial, which is fully funded and will engage third party international academic prostate cancer specialists to audit the outcomes. It was with Estrella that Suarez established the first HIFU treatment center of the Americas 13 years ago.
Suarez stressed that while medical scientists have been working on immune cell research for years, his application of immune cell therapy with the HIFU ultrasound technology is unique. He believes it will soon be proven to be an effective therapy for curing even advanced-stage metastasized prostate cancer in patients normally considered terminal cases.
“The experimental methodology I have developed working with the cellular microbiologists applies the HIFU ultrasound therapy in a unique way,” he elaborated. “We can extract and manipulate cells from a patient’s own body is in a way that is very similar to stem cell research, in that before injecting the cells back into the patient’s body we can modify the cells and grow the, we can even bank the cells for future use.
“Here we are taking your own immune system, and we are retraining it, recalibrating it, to say, ‘Go fight the cancer cells,’” he stressed. “I really think this is where we are headed in all medicine – minimally invasive therapies like HIFU, and the re-engineering of your own immune system to combat diseases like advanced-stage prostate cancer for which no known effective treatment exists today.”
The website for Suarez’s Prostate Cancer Institute in Miami describes how his HIFU treatments for prostate cancer utilizes the state-of-the art Sonablate-500 HIFU device.
The machine allows imaging and precise delivery of HIFU energy to the prostate. The neurovascular bundle can be detected via an embedded ultrasound Doppler that permits a potency-preserving HIFU treatment of the minimum amount required.
The Sonablate-500 technology destroys cancer cells in the prostrate by focusing ultrasound energy, or sound waves, on the cancer cells. At a temperature of nearly 195 degrees Fahrenheit, the ultrasound energy destroys the targeted tissue while leaving the tissue located outside of the focal lesion unharmed.
“The HIFU treatment for prostate cancer also has the advantage of being an outpatient procedure that generates absolutely no pain,” Suarez said. “The most amazing thing is the patient can go home about an hour after the procedure is done and out on the golf course the next day playing 18 holes, something unimaginable with typical prostate cancer surgery.” said Suarez.
The outcome of the procedure is determined by measuring the PSA with a simple blood test, and the result is typically “zero.” A successful procedure results in PSA being undetectable for about a month.
“In other words, for our typical patient, the HIFU procedure is successful and the targeted prostate cancer is removed,” Suarez said.
“Unlike the 13 years it took to get FDA approval for HIFU, this time it is different because we are dealing with prostate cancer patients that are at the end of the line, having exhausted all other possibilities for treatment,” Suarez pointed out. “The FDA approval to try experimental medical therapies on terminally ill patients is not nearly the difficult process we have already been through successfully.”
Suarez estimates he will have FDA approval for his combination HIFU and immune cell genetic re-engineering treatment within the next five years.
“We already have patients with advance-stage prostate cancer that we’ve treated with this new combination of HIFU and immunotherapy that have lived for 10 years,” he noted. “HIFU is already FDA-approved and the manipulation of a patient’s blood has already been used to treat a wide range of diseases, including multiple sclerosis, cancer of the kidneys and cancer of the lungs.”
He observed the FDA had already approved Provenge, a medication developed by the biotechnology Dendreon Corporation as an immunotherapy for advanced prostate cancer that takes the body’s own immune cells and reprograms them to attack advance cancer.
“It’s a lot like saying hot dogs go better with mustard,” he commented, “It shouldn’t take a genius to figure out that if I combine two things I know work – HIFU plus white blood cell immunotherapy – the combination should be better than either one alone.
Suarez stressed his innovation is to combine HIFU, an FDA-approved therapy for treating prostate cancer, with his own proprietary techniques to re-engineer white blood cells extracted, anticipating that combining the two enhances the ability of either one alone to combat prostate cancer after it has metastasized.
“We are confident we will be able to demonstrate to the FDA’s satisfaction in the next five years that men with metastasized prostate cancer survive if they treated with our combination HIFU and immune cell therapy survive,” Suarez concluded.