It's basically MRI Guided ultrasound. The numbers given for intermediate-risk patients look good but are somewhat limited in number and the result of a single-path study. I haven't seen any reports of A:B blind testing vs other treatments.... but perhaps it's too soon.
It's misleading. It was approved for removal of prostate tissue (like a TURP), not prostate cancer. It does a terrible job at treating prostate cancer.
Allen - I had thought Urology Times was reputable. I have to guess it isn't. Here is the lead on their article:
"The first commercial patient in the United States has been treated for prostate disease with the Exablate Prostate system, according to Insightec, the developer of the technology.1
The patient received the treatment at Stanford Health Care, which had previously participated in the clinical trials examining the efficacy and safety of Exablate.
The FDA granted Exablate 510K clearance in 2021 for treating prostate tissue with high-intensity magnetic resonance (MR)–guided focused ultrasound (MRgFUS). The 510(k) clearance designation allows a company to market a medical device in the United States if the company can prove that its device is “substantially equivalent” to a device already being legally marketed."
I just noticed it says "prostate disease" - not prostate cancer. That IS deceiving. Thanks for pointing that out.
The next section of it though - under clinical support seems to indicate it's being used effectively against low risk and intermediate-risk PCa:
"Clinical findings from a phase 2b study (NCT01657942) supporting the use of Exablate MRgFUS in men with intermediate-risk prostate cancer were shared at the 2021 AUA Annual Meeting.3 Overall, the study included 101 men who were treated at 7 academic centers and 1 private practice.
The average patient age was 63 years and 86% of the cohort was White. The median PSA was 5.7 ng/mL. Eighty-four patients had at least clinical stage T1c disease. Seventy-eight percent of patients were in grade group 2 and 22% were in grade group 3.
At 24 months, 88% of men had no evidence of grade group 2 or 3 prostate cancer in the treatment area according to targeted prostate biopsy. Additionally, 60% of men had no evidence of grade group 2 or 3 disease anywhere in the prostate gland, including outside of the treatment area. Serum PSA levels decreased by almost 50% after treatment and stabilized after 6 months.
Erectile function scores were slightly worse at 24 months compared with baseline (HR, -3.5; 95% CI, -5.4 to -1.6). Ten (13%) reported no sexual activity and 81% of patients achieved erections adequate for intercourse. Lower urinary tract symptoms were similar at baseline and 24 months (mean score difference, 1.1; 95% CI, 0.33-1.8).
“Overall, approximately 75% of men were able to achieve functional reactions after treatment at 24 months without starting a new erectile function medication,” Behfar Ehdaie, MD, MS, a urologic surgeon at Memorial Sloan Kettering Cancer Center and Exablate trial PI, said at the time of the AUA presentation of the results. “No patients reported urinary incontinence and the estimated probability of urinary continence over time was excellent."
???
Isn't that what Sperling out of Florida is peddling? Same sort of thing? Focal treatment guided by MRI? When I searched on the trial number - Sperlings website popped right up with something saying he was right all along..
No, it's a commercial magazine, not peer reviewed. Publications like that depend on patients not knowing how bad the results are. 40% still had prostate cancer after treatment!
It doesn't matter how good erectile function is if it doesn't do job #1 - getting rid of the prostate cancer. BTW- similar rates of erectile function preservation are reported for SBRT or HDR brachy AND they almost always cure the prostate cancer.
When the FDA rejected HIFU as a cure for prostate cancer in 2014 based on these kind of poor results, the lawyers asked the FDA to rule on whether it could be used to get rid of prostate tissue. The FDA could not object. So it is not new that the FDA has approved its use to remove prostate tissue. All that's new is that Exablate uses MRI now. Doctors are treating patients "off-label" with it.
From time to time the FDA sends a cease-and-desist letter to doctor's websites that make unjustified claims. But they do not have the manpower to police them all.
Unscrupulous doctors depend on patients not reading the fine print. Such experiments should never be done outside of a clinical trial where the patient is fully informed.
The numbers certainly aren't great, and they aren't over an extended period of time, but for low-risk patients, IF it worked it would be excellent. The question then is if it doesn't work does use of it preclude commencing with other treatment options (which do have more chances of side effects such as ED..)?
If it leaves the patient in the same condition as they were prior to treatment, then it's doing no harm with the chance of it doing some good. If that was the case - and from the provided info one can't determine that - then it might be a reasonable 1st-try treatment for low risk (say G6 or low risk G7) patients.
Just thinking a bit outside the box.. don't take it seriously..
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59 Yr Old recently diagnosed with Prostate Cancer, seeking advice on treatment options. 
SBRT or LDR Brachytherapy Treatment Options for 54 Year Old w/GG2 Diagnosis
Options becoming clearer
Trying to decide Active Surveillance vs other options
Treatment Vs No Treatment
