HIFU for Prostate Cancer: Fewer Side Effects and No Surgery or Radiation for Some Patients

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MSK medical oncologist Behfar Ehdaie, who specializes in treating prostate cancer.

Urologic cancer surgeon Dr. Behfar Ehdaie said the new treatment approach "is safe and effective to treat specific areas and greatly reduce the burden on patients.”

For people with prostate cancer considered “intermediate risk” —  small tumors confined to one area of the prostate – doctors are increasingly using a treatment known as focal therapy (partial gland ablation). One approach uses an advanced and highly precise energy source known as high-intensity focused ultrasound (HIFU). This treatment is being researched at Memorial Sloan Kettering Cancer Center (MSK) to preserve the quality of life for prostate cancer patients.

“We believe this treatment strategy will improve the lives of many prostate cancer patients,” says MSK urological cancer surgeon Behfar Ehdaie, MD, MPH. “Instead of removing all the tissue in the prostate, we have learned that it is safe and effective to treat specific areas, which is much easier for patients.”

HIFU uses ultrasound waves to kill cancer cells by heating them to high temperatures. In some patients, HIFU can be used to treat prostate cancer without having to use surgery, radiation, or chemotherapy, according to Dr. Ehdaie. This approach can reduce side effects such as such as urinary, bowel, and sexual problems.

In 2022, a clinical trial reported in Lancet Oncology demonstrated this less-invasive method works well for controlling prostate cancer in many people. The phase 2 trial, led by Dr. Ehdaie, used a particular type of HIFU treatment, called “MR-guided focused ultrasound (MRgFUS),” for men with intermediate-risk cancer.

Intermediate Risk Prostate Cancer

Approximately 40% to 50% of prostate cancers are classified as “intermediate risk,” based on PSA level, imaging tests, and information from a prostate biopsy such as Gleason score. When these cancers are confined to the prostate gland, the standard treatment options have traditionally included active surveillance (close monitoring) and – if needed — surgery, and radiation.

Dr. Ehdaie and colleagues are currently studying the five-year outcomes of patients treated in the phase 2 HIFU trial to determine if it is as effective as those other treatments at preventing prostate cancer from coming back. They also have begun a larger trial to evaluate how to improve HIFU outcomes, including making adjustments during the procedure to boost treatment intensity at precise spots in the prostate.

How Does HIFU for Prostate Cancer Work?

HIFU is an outpatient treatment given in a single session that takes about two hours:

  1. Patients are put under anesthesia, and a rectal probe is placed which enables real-time imaging and treatment.
  2. After the machine takes an image of the prostate, the doctors outline the treatment area and deliver the focused ultrasound waves, guided by ultrasound images.
  3. The ultrasound waves come from different directions, intersecting to kill the prostate cancer cells by heating the tumor to more than 158 °F (70 °C).
  4. Doctors are studying new methods to achieve real-time feedback using ultrasound micro-bubbles during the procedure to enhance ablation and ensure the right spots are treated. They can make real-time adjustments.
  5. The patient wakes up from the anesthesia and goes home. There are no incisions or wounds on the body to heal. Patients can return to normal activities right away.

HIFU for Prostate Cancer Clinical Trial Results

In the phase 2 clinical trial, 101 men received the HIFU treatment.  They were biopsied six months and 24 months later. For nearly 90% of the patients, there was no intermediate- or higher-risk cancer left in the treated area.

We have demonstrated the procedure is safe for patients, and they can return to normal activity right away.
Behfar Ehdaie surgeon

“Probably most important was the preservation of quality of life and minimal side effects,” Dr. Ehdaie says. “Nobody in the study reported urinary incontinence or experienced bowel problems. Most men were able to achieve erections.”

Based on this data, the FDA granted approval for the technology to treat prostate tissue. MSK has been on the cutting edge of many focal therapy treatments, including irreversible electroporation, which also recently received FDA approval for prostate tissue ablation in a trial led by urologic surgeon Jonathan Coleman, MD.

Prostate Cancer HIFU Treatment Patient Success

John Brannan is grateful he was able to be treated with HIFU.  He was diagnosed with prostate cancer at age 65 after his prostate-specific antigen (PSA) began rising steeply in 2016.  Although prostate cancer is usually not hereditary, he was alarmed because his father, uncle, and two cousins all died from the disease. A local doctor in Boston suggested surgery to remove the cancer as soon as possible.

Then John learned about MSK’s clinical trial investigating HIFU and met with medical oncologist Howard Scher, who referred him to Dr. Ehdaie.

MSK prostate cancer patient John Brannan with wife.

John Brannan, with wife Lita, called the HIFU treatment “a phenomenal use of technology.”

John was eager to enroll. “In addition to personal reasons for wanting this treatment, I also hoped to help the next generation who might benefit,” he says. “I’ve seen the effect this disease can have on my own family.”

John says participating in the clinical trial was easy. Dr. Ehdaie scheduled the HIFU procedure at Memorial Hospital in September 2016. John walked out several hours later and went back to the hotel with his wife and had dinner.

“It was pretty much back to normal right away,” he says. “No cutting, no stiches, no lying in a hospital bed for days or weeks. I wore a catheter for the first 24 hours and was a little tired, but that was it. The treatment was actually less painful than the biopsies I have had.”

A More Nuanced Approach to Prostate Cancer Treatment

Dr. Ehdaie says that using HIFU focal therapy for intermediate-risk cancers became possible due to two important developments over the past 15 years. First, it became acceptable to use active surveillance to monitor patients with low-grade tumors. Second, new imaging methods were incorporated into ultrasound treatment. As a result, the therapy is delivered with extreme precision.

“In the past two decades, we have found better ways to treat prostate cancer successfully while preserving quality of life for patients,” says Dr. Ehdaie. ”Now focal therapy is becoming another option for patients whose disease has not spread.”

‘A New Lease on Life’

Nearly nine years after HIFU treatment, John is still doing well and has avoided surgery and radiation treatment. He has yearly follow-up checkups and periodic surveillance biopsies at MSK to make sure the disease has not returned. Now 73, he lives in Florida with his wife, Lita, and stays active by buying and renovating properties. They recently opened a floral and gift studio.

Since his treatment, he has received calls from friends and acquaintances all over the country asking how they can get it too.

“I feel like I was given a new lease on life, so I’m trying to make the most of it,” John says. “It’s a phenomenal use of technology, and I think it’s going to absolutely take off across the world.”

Key Takeaways

  • Some men with intermediate-risk prostate cancer may not need surgery or radiation.
  • A new approach uses high-intensity focused ultrasound (HIFU) to destroy prostate tumors.
  • The treatment can control prostate cancer with greatly reduced side effects.
  • This approach could change treatment for many prostate cancer patients.
  • MSK experts are studying long-term outcomes using HIFU focal therapy and starting clinical trials to improve energy inside the prostate gland as well as ways to reduce disease recurrence.

 

 

The study was partially supported by NIH/NCI Cancer Center Support Grant P30 CA008748. In addition, the MSK authors acknowledge the support of MSK’s Sidney Kimmel Center for Prostate and Urologic Cancers.

Please see the full paper for additional funding and disclosure information.