Prostate cancer is the most common cancer among men, after skin cancer. According to the American Cancer Society, there will be more than 161,000 new diagnoses this year alone. For decades men suffering from prostate cancer have had two primary modalities for treating prostate cancer:

(1) Watchful waiting or active surveillance—Often indicated for patients diagnosed with a low-risk disease, this “wait-and-see” option can be stressful for patients who have been told they have cancer. Urologists will typically monitor the patient over time since prostate cancer is slow growing. But the patient may prefer to seek treatment right away and not risk waiting, especially if he knows there are several efficient treatment options available.

(2) Radical treatment—Radical treatment, at the other end of the spectrum, involves either surgery or radiation therapy, both which can cause serious side effects, most notably incontinence and erectile dysfunction. If a patient is diagnosed with localized prostate cancer, cancer that has not spread beyond the prostate gland, urologists may recommend radical surgery or radiation, instead of active surveillance.

Thanks to advances in ultrasound technology, however, men have another option: High Intensity Focused Ultrasound (HIFU). HIFU is a non-invasive procedure that directs high-frequency sound waves to ablate prostate tissue, and has a low risk of the side effects associated with traditional prostate treatment modalities: incontinence and impotence.

HIFU focal ablation can fill a significant void, bridging the gap between active surveillance and radical treatments. HIFU uses a non-invasive probe that goes through a natural orifice, and only targets a small part of the prostate and destroys it without damaging other surrounding structures that control sexual and bladder function.

On June 7, 2018, the US Food and Drug Administration cleared a HIFU medical device called Focal One for prostate tissue ablation. This next generation HIFU system is even more precise in targeting diseased tissue in the prostate. Focal One fuses MR and 3D biopsy data with real-time ultrasound imaging, which allows urologists to draw close margins around the targeted tissue and ablate an even smaller portion of the prostate. This lessens the damage to healthy tissue, and, again, minimizes side effects of incontinence and impotence for patients.

HIFU is not without controversy, however. Again, HIFU is FDA cleared for prostate tissue ablation but not for prostate cancer treatment, even though 50,000 men have undergone the procedure throughout Europe and Asia, among other locations throughout the world, and urologists in the US are using HIFU as a treatment for localized prostate cancer.

In the U.S., HIFU is being studied for long-term effectiveness at the University of Miami. The 50 patients who participated in the study have so far experienced fewer side effects of incontinence and erectile dysfunction. All patients had been diagnosed with localized prostate cancer—with various Gleason scores—and were eligible for focal HIFU.

While most men who opt for the HIFU procedure pay out of pocket, that is gradually changing. In March 2018, CIGNA became the first major private health insurer in the U.S. to cover HIFU as a salvage therapy for prostate cancer patients who failed radiation. Medicare offers partial coverage as well.


Three Men Tell Their Stories about Why They Chose HIFU
Harry B.

Harry, felt he was the picture of health, having completed his 75th marathon [26.2 miles] at age 75. So, he was as shocked as anyone when he got the diagnosis: aggressive prostate cancer.

“I had no symptoms whatsoever,” Harry recalls. “My cardiologist was concerned after doing some routine blood work. My PSA level [prostate-specific antigen] was elevated and she recommended I get my prostate checked.”

After a trip to a urologist and an MRI, Harry was referred to the offices of Dipen Parekh, MD, urologist, surgeon. Dr. Parekh offered Harry the traditional options for addressing his condition: radical prostate surgery or radiation. He also offered HIFU because even though the cancer was aggressive it had not spread beyond the prostate.

Harry chose the HIFU procedure.

It’s less invasive and I was in and out in one day. If it fails I could still do the other procedures or repeat HIFU. If I had radiation or a prostatectomy, I couldn’t do them again. I had the procedure in March of 2017 and did three marathons after that!
Just as Harry continues to train for more marathons in the future, it seems there’s no stopping him.

Thomas N.

If I could have blown a whistle and called a foul in the doctor’s office I might have done it.

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Thomas wasn’t out on the court. Instead, he was trying to make sense of what the doctor was saying. “I could see his mouth moving, but I couldn’t understand a word. My wife urged me to listen.”

At 64, Thomas was diagnosed with early-stage localized prostate cancer. He was being treated by Dr. Clifford Gluck, a urologist in Hingham, MA and the first in the Boston area to offer HIFU. Dr. Gluck explained the pros and cons of his medical options, including HIFU.

Thomas decided upon HIFU when he heard that within a month of having the procedure he’d likely be able to get back to refereeing, working with school kids, teaching them basketball and helping them stay out of trouble. “Also my primary physician told me if he had to make the choice, he’d go with HIFU too.”

Thomas was pleased that the HIFU procedure would lower the risks of side effects like incontinence or impotence.

Because my wife is a 23-year breast cancer survivor, I could relate to the comparison between HIFU and a breast lumpectomy, where the surgeon removes only the area containing cancerous tissue, not the entire breast. With HIFU, the process is similar, because the doctor uses a probe to target the exact location of a suspicious area within the prostate and directs the ultrasound waves to destroy only that diseased tissue, which spares the remainder of the prostate gland.
During recovery, Thomas got stronger and stronger. He was able to jog and lift weights within six to eight weeks and run up and down the court. “I did have a catheter initially, and after it was removed I wore protective undergarments because there was some leakage in the early stages. Now, that’s less and less and I didn’t really have the two major side effects.”

Thomas is very glad he went through the HIFU procedure.

I only wish more men would pay attention to taking care of their bodies. When I tell my fellow African-American friends about how important their health is, they look at me like I have two heads. But they need to get over the idea of having their prostates checked, especially because African-American males are twice as likely to die from prostate cancer as white men [bold added for emphasis].

Charles B.

Charles was diagnosed with prostate cancer in 2016. He is 66, and as of July 1st, 2017, retired. “The last time I was in a hospital was for a hernia operation, nearly 40 years ago.”

At a routine check-up, Charles’ physician ran a battery of tests and noticed his PSA count was elevated, and sent him to a urologist.

My PSA count was higher still. Looking at records of past check-ups, my PSA had been steadily rising and was cause for concern. The doctor ordered an MRI which unfortunately indicated a high probability of cancer. The urologist suggested I consider prostatectomy—removing the entire prostate. I was in a state of shock.
Charles’ urologist recommended he see Dr. Arieh Shalhav at UChicago Medicine (UCM) because he is considered a leader in the field of minimally invasive urologic surgery.

Dr. Shalhav discussed the various conventional treatments. First, Charles needed to have a biopsy to better understand what was actually there. “My MRI was used to guide the biopsy, which confirmed the cancer. Fortunately, it was confined to one side of the prostate, meaning it had not spread beyond that, but it needed to be addressed.”

Dr. Shalhav discussed robotic prostatectomy, as opposed to the conventional open surgery, and also mentioned that UCM had installed a medical device called Ablatherm Robotic HIFU. He thought Charles was a good candidate for HIFU because the cancer was localized.

Charles wanted more opinions but wanted to avoid surgery to remove the prostate because of the two common side effects. He saw a doctor at Northwestern University who strongly recommended robotic prostatectomy.

Based on his advice, and what I had read about survival and complication statistics, I was about ready to do the full prostatectomy—the radical nerve-sparing procedure. I went ahead and scheduled the procedure. However, the idea of cutting out the entire prostate and the urethra, and all that goes with that kind of surgery continued to nag at me. I spent more time on the Internet researching treatments until one day I saw that Medicare had approved partial coverage of the HIFU procedure.
Just two days before the scheduled surgery Charles called Dr. Shalhav and confirmed he would go ahead with HIFU instead.

“I chose HIFU because when I looked at the statistics for this procedure versus a radical prostatectomy, it just seemed HIFU was the way to go and would give me a better quality of life. Unlike some of the other technologies, if they weren’t able to remove all the cancer with HIFU I could repeat the procedure, and if, in the end, the only answer became a prostatectomy, I still had that option.

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I know too many people who have, in fear of the worst disease outcomes, gone to extremes for treatment. The side effects of the treatment had a lot of other negative consequences. So it appealed to me to start with something that’s not quite so dramatic and HIFU seemed to be the answer.

I’m sure there are thousands of guys across the country who are in the exact position I was in. It’s important they know that HIFU is available and more accessible than ever because of partial Medicare reimbursement (and CIGNA reimbursement for HIFU as a salvage therapy). HIFU enables people like me to use something more appropriate for treatment rather than the more intrusive, extensive surgery like prostatectomy.”

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