Prostate cancer is the second most common cancer among men, behind skin cancer. About 1 in 9 men will be diagnosed with this disease during his lifetime. Here at the University of Miami Miller School, we conducted the first U.S. clinical cohort study with 50 patients using the Ablatherm Robotic HIFU (High Intensity Focused Ultrasound) system for treatment of early stage prostate cancer. The results were very promising, and the study is on going as we continue to enroll patients.
For decades men suffering from prostate cancer have had two primary choices for treatment – radiation therapy or radical surgery to remove the entire prostate – both of which cause life-altering side effects of impotence or incontinence. HIFU, the result of advances in ultrasound technology, is a noninvasive procedure that directs high-frequency sound waves to ablate prostate tissue, with a low risk of the side effects associated with traditional treatments.
Study Confirms HIFU’s Safety, Efficacy and Benefits for Patients’ Quality of Life
Preliminary results of the study demonstrated promising oncological short-term outcomes, even in clinically significant prostate cancer.
All patients who participated had been diagnosed with localized prostate cancer, cancer that has not spread beyond the prostate gland, and were eligible for focal HIFU therapy.
As noted, the treatment options before HIFU – radiation or surgery – caused significant physical side effects, and the only other possibility took an emotional toll. Doctors sometimes would employ what was known as “watchful waiting,” or “active surveillance.” For patients diagnosed with a low-risk disease, this “wait-and-see” option involved urologists monitoring the patient over time, since prostate cancer is slow growing. Though medically valid, it was stressful for patients with active cancer and many ultimately preferred more aggressive treatment options despite the side effects.
HIFU focal ablation has the potential to fill that void between active surveillance and radical treatments. It allows patients to maintain their quality of life. It uses a noninvasive 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, the Food and Drug Administration cleared a HIFU medical device called Focal One for prostate tissue ablation. This next-generation HIFU system fuses MRI and 3D biopsy data with real-time ultrasound imaging, which allows urologists to ablate an even smaller portion of the prostate. This lessens the damage to healthy tissue, and, again, minimizes side effects for patients.
Miami resident Harry Bateman (“Bate”) Blair who eventually enrolled in the University of Miami study, felt he was the picture of health, having completed his 75th marathon at age 75. He topped that feat the following year when he finished his 76th marathon at age 76, nearing his goal of running in all 50 states. So, he was as shocked as anyone when he got the diagnosis: prostate cancer.
“I had no symptoms whatsoever,” said Blair, “but my cardiologist was concerned after doing some routine blood work. My PSA level (prostate-specific antigen) was elevated and she recommended that I get my prostate checked.”
Blair ultimately was referred to the offices of Dipen Parekh, MD, urologist, surgeon and co-investigator of the University of Miami study. Parekh performed a MRI-guided biopsy, which determined Blair had a more aggressive type of prostate cancer.
Parekh offered him the traditional options for his condition – radical prostate surgery or radiation. Typically, focal ablation is not offered to patients diagnosed with aggressive prostate cancer. However, testing indicated Blair’s cancer was limited to one specific area of the prostate.
Blair chose the HIFU procedure “because it’s less invasive and I was in and out in one day. And if it fails I could still do the other procedures. But if I had radiation or a prostatectomy, I couldn’t do them again.” He is being closely followed, as required by the study.
“I had the procedure in March 2017 and did three marathons after that.” And, today, he continues to train for future marathons.
The positive results from the cohort study come on the heels of other positive HIFU news.
Earlier this year, renowned medical institutions, including the University of Miami, Weil Cornell, Houston Methodist Hospital, Duke University and the University of Southern California joined forces to launch the Focal Robotic Ultrasound Ablation (FoR-UsA) Registry – the first U.S.-based HIFU registry created to collect high quality clinical data on hundreds of patients.
In addition, CIGNA became the first major private health insurer in the U.S. to cover HIFU salvage therapy for prostate cancer patients who failed radiation following the update from the recommendations of the National Comprehensive Cancer Network (NCCN) guidelines.
The oldest medical school in Florida, founded in 1952, the University of Miami Leonard M. Miller School is the only medical university in Florida where the HIFU procedure is available to prostate cancer patients.