Researchers at Weill Cornell Medicine are calling for caution and more data to evaluate the effectiveness and safety of using high-intensity focused ultrasound (HIFU) in treating prostate cancer.
The treatment blasts high-frequency ultrasound waves through the walls of the rectum, generating enough thermal energy to destroy prostate tissue. It's designed to kill prostate cancer cells while keeping the gland intact, thus preserving urinary and sexual function.
Though the treatment holds the hope of such benefits for prostate cancer patients, the researchers said in a recently published paper in JAMA that registries should be created to generate more data and evaluate control and safety issues.
"Although I believe that this therapy will be useful for some men preferring to avoid treatment of the entire prostate, it remains to be seen what the ideal patient and tumor characteristics are for HIFU," Dr. Jim Hu, one of the authors and an oncologist at Weill Cornell Medical Center, told the Cornell Chronicle.
Although the FDA recently approved this form of treatment, which has been called a lumpectomy for men, for tissue ablation, the technique has yet to gain regulatory approval as a treatment for prostate cancer.
That means insurers won't cover the costs, which means men who want to be treated with HIFU for prostate cancer have to shell out up to $25,000.
"The lack of data--particularly comparative information--is a major hurdle for regulatory and payment decisions," said Dr. Art Sedrakyan, co-author and a professor of healthcare policy and research at Weill Cornell Medicine.
In U.K. studies the authors examined, they found that only 50% of men achieved continence and potency preservation with the absence of cancer after having HIFU. Still, Hu said, head-to-head comparisons are hard to make because European men are often diagnosed with prostate cancer at later stages than those in the U.S.
The researchers also said in the paper that although HIFU has a lower estimated cost versus alternate treatments, its costs would most likely increase over time due to treatment failure, which could lead to repeat HIFU procedures and ultimately a switch to external radiation therapy or surgical treatments.
"Our specific recommendation is that we need a registry where clinicians could contribute data, and this would allow us to do real-life evaluation of short-term and long-term outcomes," Sedrakyan said.
Both Hu and Sedrakyan as well as partners from the FDA and the device manufacturers are scheduled to meet at the FDA July 22 to develop a registry consisting of academic and community centers nationally.