Localized Prostate Cancer Management with High-Intensity Focused Ultrasound

High-intensity focused ultrasound (HIFU) is now available at Cleveland Clinic Indian River Hospital, offering a new focal therapy option for carefully selected patients with intermediate-risk prostate cancer. This non-invasive treatment is performed by Jamil Syed, MD, a board-certified urologic surgeon with specialized training in multiple focal therapies.

About one in eight men in the United States will be diagnosed with prostate cancer in their lifetime, reports the American Cancer Society. Approximately half will be diagnosed with intermediate-risk prostate cancer and some may be candidates for focal therapy, which has emerged as a middle ground between active surveillance and whole-gland therapies like surgery or radiation.

"The category of focal therapies is growing and providing more opportunities to personalize prostate cancer care," states Dr. Syed. "HIFU is one of the options we can offer some patients who want to avoid the side effects associated with more aggressive treatments but are not comfortable with monitoring alone."

Focal therapies

HIFU delivers focused ultrasound energy to a defined area of the prostate, heating and destroying the cancerous tissue. The energy is delivered via a rectal probe, making lateral and posterior lesions more accessible, according to Dr. Syed. “These areas are easier to reach with the probe, and it allows me to follow the contour of the edges,” he says.

At Indian River Hospital, HIFU is performed using the Focal One® system. It is the same platform used at Cleveland Clinic’s main campus in Ohio, which was among the first U.S. institutions to adopt the technology following its clearance by the U.S. Food and Drug Administration in 2018 for ablating prostatic tissue.

For lesions located on the anterior or superior aspects of the prostate, however, Dr. Syed often recommends irreversible electroporation (IRE), another form of focal therapy offered at Indian River Hospital. Performed using the NanoKnife® System, this non-thermal technique uses electrical pulses to change the permeability of cell membranes, leading to cell death. 

“During IRE, probes are inserted through the perineum into the targeted treatment zone allowing the cancer cells to be ablated while preserving the surrounding structures,” describes Dr. Syed.

Research has demonstrated that both HIFU and IRE have a lower risk of urinary incontinence and erectile dysfunction than radical therapy, as well as a low risk of complications.

“With HIFU, careful preoperative planning includes evaluating rectal wall thickness, particularly in patients with prior radiation exposure,” adds Dr. Syed. “We use real-time temperature monitoring during the procedure to minimize the risk of injury.”

Patient selection is key

Focal therapy, including HIFU, is appropriate only for select patients–primarily those with Gleason Score 7 (3+4 or 4+3) tumors localized to a single region of the prostate. Dr. Syed points to advancements in biopsy techniques and genomic testing that have helped improve patient selection.

“When we biopsy the prostate, we’re taking samplings from all around the gland,” he explains. “If the cancer is isolated to one side that patient may be a good candidate for focal therapy.” 

Additional criteria to be a candidate for HIFU includes having a normal-sized prostate and no contraindications, such as rectal stricture or a latex allergy, which may limit the use of the equipment. If the prostate is too large, notes Dr. Syed, the energy may not be able to reach and ablate all the cancer cells, which can lead to positive treatment margins.

In addition to being used as a primary treatment, he also advises that HIFU may be used as a salvage treatment in certain cases when cancer has returned after radiation therapy.

Risk of recurrence

Dr. Syed notes many patients referred to him for focal therapy ultimately don’t qualify, either because their disease is more extensive or of higher risk.

“These patients are more likely to experience recurrence if not treated with whole-gland therapy,” he says. “There’s no room to gamble with under-treatment, especially if someone has 20 years or more of life expectancy.”

As such, the American Urological Association (AUA) currently recommends focal therapy only in the context of clinical trials for patients with favorable intermediate-risk disease. Standard treatment remains radical prostatectomy or radiation with ADT for individuals with unfavorable intermediate or high-risk cancer and life expectancy over 10 years.

“Because of the risk for recurrence or the development of new cancer in untreated regions, I make it clear to patients that close monitoring is critical after treatment,” he advises. “That entails PSA testing every 3 to 6 months, with repeat transperineal biopsies at the one- and two-year marks.”

Should cancer return, patients remain candidates for salvage radical prostatectomy or radiation therapy.

Investigational yet promising

Dr. Syed is currently the only Cleveland Clinic surgeon in Florida offering HIFU and IRE for localized prostate cancer management. While both treatments are still investigational, he sees their potential for improving quality of life when appropriately applied. That sentiment is echoed by the many academic centers across the U.S. that are offering focal therapies.

“With thoughtful patient selection and meticulous technique, HIFU represents a promising option in the expanding spectrum of prostate cancer treatment,” he asserts. “As experience grows and outcomes mature, focal therapies may become a mainstay for well-selected men seeking an alternative to surveillance and definitive therapy.”