Focal Point

First Urology pioneers high intensity focused ultrasound (HIFU) treatment for prostate cancer

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LOUISVILLE When I think of Nassau, Bahamas, and Cancun, Mexico, I picture white sand beaches, crystal blue waters, and vacation resorts. Perhaps the last thing on my mind would be a destination for medical treatment. But for one group of local urologists, traveling to the Bahamas and Mexico, among other international locales, was the only way to provide their patients with leading-edge therapy for prostate cancer. Until now.

Prostate cancer is the most common cancer in men and affects one out of seven men during their lifetime. The incidence is higher in African-American men and in those with a family history of prostate cancer. The traditional treatments of radical prostatectomy and radiation therapy can be curative but may have life altering side effects, such as urinary incontinence and erectile dysfunction.

Now, a new treatment is available in Louisville for patients with early to intermediate prostate cancer – high intensity focused ultrasound (HIFU). Although it’s been in existence and performed around the world for 15+ years, HIFU was just approved by the FDA in October 2015. An outpatient procedure using ultrasound energy that converges at a focal point to ablate cancer cells and spare normal tissue, HIFU promises results equal to those of conventional treatments with fewer side effects. Thanks to the efforts of John Jurige, MD, and his colleagues at First Urology, Louisville boasts the first center in the US to perform HIFU.

International Training Ground

John Jurige, MD, board-certified urologist with First Urology and Sonablate® HIFU proctor, is a native Louisvillian who completed medical school and residency at the University of Louisville (U of L). He was drawn to urology because his father was a urologist but also because he enjoyed the varied patient mix, the balance of medical and surgical interventions, and the ever-evolving technologies. “I liked having something that had a beginning and an end, something that had a disease, a treatment, and an outcome,” says Jurige. After his training, he joined his father’s practice, and later recruited other physicians. In January of 2011, they merged with Metro Urology to form First Urology.

It was nine years ago that a few of Jurige’s patients brought the idea of HIFU to him. He diligently did his research and visited centers in the Bahamas, Mexico, and Canada to observe the procedure. “I was so impressed with the precision of the energy delivery and talking to patients I met on trips who had a quick recovery and minimal impact on quality of life issues,” says Jurige.

In February 2008, Jurige took his first patient to Cancun to perform the procedure, and that favorable outcome set the future in motion. Jurige spent the next eight years traveling outside the US one or two weekends a month, primarily to Nassau and Cancun, to perform HIFU on his patients.

Around 2010, Jurige’s colleague, board-certified urologist Brooks Jackson, MD, also began performing HIFU at international centers. “What really got me interested in HIFU was the fact that it was an outpatient procedure, it provided improvement in potential complications that the other treatment options had, and the data appeared to show that the results for local, confined prostate cancer were as good as the other techniques with less side effects,” says Jackson.

Jackson is also a graduate of the U of L School of Medicine and the urologic residency program at U of L. He practices general urology in adults and children with a special interest in stone disease and urologic oncology. “The one thing about urology is it provides the ability to take care of both children and adults. It allows you the opportunity to extend your practice to endeavor upon things such as kidney transplants. You can extend as far as you want,” he says.

As one of the first US urologists to adopt HIFU and one of the most prolific, Jurige was a natural fit to open the first HIFU treatment center in the US in Louisville. The center, called HIFU Prostate Services (HPS) Kentucky, is a partnership between First Urology and HIFU Prostate Services, which provides administrative support to the practice.

Decoding Prostate Cancer

Historically, early to intermediate prostate cancer has been treated with radical prostatectomy (removal of the prostate) or radiation therapy. Prostatectomy is very effective at curing cancer but carries side effects that hinder quality of life, primarily urinary incontinence and erectile dysfunction. With radiation therapy, the side effects are fewer but the cure rate is lower.

Research has led to a better understanding of the behavior of prostate cancer in recent years, which has opened up a variety of treatment options. One of those is active surveillance. “About 80 percent of prostate cancers that we find on biopsy take about three-to-four years to double in size. That’s the reason most patients won’t manifest a problem until 10 years out,” says Jackson. “However, there is a subset of prostate cancers that can grow much more aggressively, and as such, need to be detected and treated, even in the elderly where aggressive prostate cancer may have a 30 percent mortality rate.”

Urologist John Eifler, MD, who joined First Urology in August 2015 and is the practice’s third HIFU surgeon, attributes prostate cancer’s slow-growth rates and long-term survival outlook to the advent of new techniques that look to preserve quality of life. “Often men diagnosed today may not die for 20 or 30 years, and as a result of that, we’ve started to focus more on not just curing cancer but making sure that after their treatment they not only live a long life but a good life with a functional treatment outcome.”

Eifler is also from Louisville and completed his undergraduate degree at the University of Kentucky. He attended medical school at Cornell University and then did a one-year research fellowship at the National Institutes of Health (NIH). He took his urology residency at Johns Hopkins University and pursued an oncology fellowship at Vanderbilt University. “Very few people go into medical school and think they would like to be a urologist. It was the same for me,” says Eifler, who thought he wanted to be an ENT or orthopedic surgeon. “After my electives, I loved urology.” He was drawn to the large, complex surgeries and the ability to cure a patient’s disease with surgery.

The Advantages of HIFU

HPS Kentucky uses the Sonablate HIFU, the first device FDA approved for prostate ablation. The Sonablate HIFU utilizes a specialized ultrasound probe introduced rectally that provides three-dimensional imaging of the prostate and delivers the ultrasound energy. “As these ultrasound waves come off the transducer, they are unfocused and therefore low energy. As they move through the tissue, including the rectum, the waves all converge in a focal point. At that focal point, there’s a very intense thermal reaction where the tissue reaches 100 degrees Celsius. That’s incompatible with cellular life, so the tissue is ablated, vaporized, destroyed,” says Jurige. The technology allows physicians to avoid damaging the neurovascular bundles that regulate erectile function and the muscular sphincter that provides bladder control, therefore preserving erectile and bladder function.

The procedure is performed as an outpatient at the Louisville Surgery Center. The procedure does create a temporary swelling of the prostate, so patients go home with a catheter for five to seven days until normal urinary function returns. Most can resume normal activities within a week or two.

At this time, HIFU is not covered by most insurances because Medicare has yet to assign the procedure a CPT code.

Of those eligible for the procedure, Jackson says, “The ideal candidate is a gentleman who has localized prostate cancer, has a small prostate gland, and has pretty normal erectile function. There are some patients we have to be cautious of depending on comorbid problems, as well as prostate size and a higher risk of having disease that extends beyond the confines of the prostate.”

Patients may be eligible for HIFU if they have low to intermediate risk prostate cancer and meet the following medical criteria:

Prostate specific antigen (PSA) score less than 15
Gleason score of 6 – 8 (The Gleason system is a microscopic assessment of the aggressiveness of the cancer.)
Prostate size less than 40 grams

One of the advantages of HIFU is that it can be used before or after other treatments. “One of the nice things about HIFU is that it doesn’t rule out other therapies,” says Eifler. “Another thing to note is that patients who have been treated with other forms of therapy in the past but have recurred can receive HIFU as an additional treatment option.”

Visualize, Localize, and Vaporize

HIFU is not the only new tool in urologists’ toolbox when it comes to prostate cancer.

Traditionally, prostate cancer screening has involved digital rectal exams and prostate specific antigen (PSA) blood tests. “Most cancers, when you diagnose them, you can perform an imaging study to tell you exactly where the cancer is. In prostate cancer, that has never been the case. It’s not visible on CT scans. It’s not visible on ultrasound,” says Eifler. “With newer, more powerful MRIs and MRI techniques, we are now able to identify the higher-grade aggressive prostate cancers the majority of the time.” Prior to MRI, patients with a suspicion of prostate cancer would have an ultrasound and random biopsies, which could miss the cancer completely or over diagnose it.

First Urology is not only using MRI to screen for prostate cancer but also to pinpoint the exact location of cancerous cells within the prostate and provide more targeted treatment. A technique called MRI/ultrasound fusion incorporates MRI imaging into the HIFU software, essentially drawing a bullseye directly on cancer cells. Soon, the center will offer focal HIFU, which precisely targets only the cancer cells and surrounding margin rather than the entire prostate, for patients whose cancer is localized to one area. With focal HIFU, there are essentially no side effects, and patients go back to work the next day.

Because HIFU has been performed throughout the world for over 15 years, there is published long-term data, primarily from Europe and Japan. “What the data shows is that for stage T1 prostate cancer, the 10-year cancer free survival is 92 percent. That is about equivalent with radical prostatectomy,” says Jurige. “With more advanced stages of prostate cancer, survival changes. The probability of a cure rate when cancer is outside the capsule of the prostate is about 50 percent with surgery and 50 percent with HIFU. Those patients often need additional treatment down the road.”

MRI is not the only tool being used to provide more targeted cancer therapy. “One thing that I think our group has done a great job of spearheading is using biomarkers to really individualize prostate cancer risk,” says Eifler. “Before we relied on what the pathologist sees under microscope and the PSA. Now, we can get data on literally 1.4 million different genes within the prostate cancer cell to really fine tune how your cancer is going to behave and what is going to be the best treatment for you.”

It is also important to note that HIFU does not replace radiation therapy or surgery for prostate cancer in all cases. “Primarily for more advanced disease, we still recommend surgery and radiation therapy for the people with the highest risk,” says Eifler. While controversial in some specialties, robotic surgery for radical prostatectomy has become increasingly mainstream due to the increased visualization it provides. “The robot allows us an avenue to get great visualization both in the dissection and when reconstructing the urinary tract at the end of the case,” says Eifler.

Currently, HPS Kentucky is the only HIFU center in Kentucky, and Jurige is one of only three Sonablate proctors in the US certified to train other physicians in the procedure. Soon, First Urology and HPS Kentucky will be extending their physician training within a 150-mile radius to include Lexington, Indianapolis, Columbus, and Cincinnati. In the meantime, HPS Kentucky has a concierge service that helps patients across the region with general HIFU information, travel accommodations, and more.

Whatever the tool, the new leading-edge technologies in the diagnosis and treatment of prostate cancer are allowing patients a choice and physicians a bevy of options to provide less-invasive treatment with fewer side effects and curative results.

WHY UROLOGISTS STILL RECOMMEND PSA SCREENING

According to urologist Brooks Jackson, MD, the advent of prostate specific antigen (PSA) screening for prostate cancer brought about a dramatic increase in the detection of early cancers. “We found that before PSA and the combination of annual rectal examinations with PSA, about one-third of prostate cancer patients presented with metastatic disease. That number dropped to around five percent with the advent of PSA,” says Jackson. “The problem is that studies show that 30 percent of patients with prostate cancer are possibly being over treated.” This is related to the shortcomings of ultrasound-guided biopsy alone to determine cancer risk (see cover story) and the fact that the generally slow growth rate of prostate cancer means people often die of other causes.

The overtreatment statistics led the US Preventive Services Task Force to recommend against PSA screening in 2012. However, the recommendation has left urologists concerned that prostate cancers will not be caught early enough. The American Urological Association and the American Cancer Society recommend men discuss PSA screening benefits and risks with their doctor. “In the urology community, we still feel very strongly that the PSA and digital rectal examination complement each other to detect early prostate cancer,” says Jackson.


General screening guidelines include:

Baseline screening at age 50 for men at average risk
Screening beginning at age 40–45 for men at higher risk, including African-Americans and those with family history of the disease