Focal ablation yields lower treatment failure rates than surgery for prostate cancer
Newly released clinical trial results suggest that focal ablation is a viable alternative to radical prostatectomy for patients with unilateral, clinically significant prostate cancer (PCa).
The Focal Ablation Versus Radical Prostatectomy (FARP) Study is the first randomized controlled trial to compare the use of ultrasound energy-based focal ablation (FA) to robot-assisted radical prostatectomy (RP). The results were shared this week during the American Urological Association’s annual meeting.
During the connference, EDAP TMS—a leader in robotic energy-based therapies that harness the power of ultrasound technology, and provider of the FA tools used in the FARP trial—revealed that the study had achieved its primary endpoint, providing ample evidence on the efficacy of FA. In fact, after three years, its failure rate was lower than that observed among trial participants who had undergone prostatectomy.
The trial included 213 patients with clinically significant PCa who were randomized to either an FA group (using transrectal high intensity focused ultrasound, Focal One) or an RP group. For the FA group, treatment failure was defined as patients having to undergo additional treatment—either RP of radiation therapy—due to the presence of high-risk PCa ineligible for repeat FA; in the RP group, this was defined as patients having post-treatment PSA levels higher than 0.2 ng/ml. MRI, biopsies and bloodwork were used to monitor treatment response.
Both groups had similar PSA levels, tumor diameters and prostate volumes at baseline and they were well matched in age. At three-year follow-up, failure rates between the two treatments were similar; FA achieved a failure rate of just 6.5%, while RP’s rate was slightly higher, at 8.5%. Though the results yielded just a 2% difference, FA’s failure rate is considered noninferior to RP, the gold standard for PCa.
Chief Executive Officer of EDAP TMS, Ryan Rhodes, expressed enthusiasm for how the trial’s results will impact prostate care in the future, as FA treatments carry significantly lower risk of negative treatment side effects.
“We anticipate that the positive data from the FARP trial, once published, combined with the recent publication of the HIFI Study, the largest prospective, comparative study ever conducted demonstrating Focal One’s ability to provide comparable cancer control and superior urinary and erectile function preservation as compared to surgery, will be instrumental in further accelerating adoption of Focal One Robotic HIFU,” Rhodes said in a release.
“The findings from this randomized controlled trial provide significant additional evidence that support the use of focal ablation with ultrasound energy for the management of organ-localized prostate cancer, in particular HIFU,” added the study’s principal investigator Eduard Baco, MD, PhD, an associate professor at the Department of Cancer Surgery at Oslo University Hospital in Norway.
Learn more about the trial’s results in this study abstract.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.