Unpacking the Optimal Role of Focal Therapy in RCC

Focal therapy has reshaped how urologists think about the management of small renal masses, offering a middle path between watchful waiting and the operating room. But as ablative technologies grow more sophisticated and more widely available, so too does the risk of misapplication, according to Alexander Kutikov, MD, FACS.

“Focal therapy is more active than surveillance and less invasive than surgery,” Kutikov said in an interview with OncLive®. “[However], focal therapy should never be a replacement for surveillance, [and] it shouldn’t substitute for a surgical skill set. Urologists shouldn’t look at a renal mass, think it’s too complex for partial nephrectomy, and then pivot to ablation. Those are the masses that fail ablation. Anatomic complexity drives ablation outcomes, and those masses that are deeper [and] more central are tougher to treat with ablation. Ablation has its role for the right patient, but its implementation has to be precisely calibrated.”

In the interview, Kutikov shared highlights from a discussion he led during the 2026 American Urological Association (AUA) Annual Meeting on the evolving role of focal therapy in renal cell carcinoma, including patient selection considerations, how focal therapy affects disease recurrence rates compared with surgical resection, and unanswered questions in the space that necessitate further investigation.

OncLive: What characteristics are you weighing when determining which patients are suitable candidates for focal therapy?

Kutikov: Focal therapy has been best studied and best utilized in older, comorbid patients who have competing risks, but have a mass that’s growing, a mass that’s been proven to be a cancer, and a mass that needs to be treated. Focal therapy is a great alternative to a high-risk surgery, and that’s where most of our data lie. [However], there are certain patients that don’t want to undergo surgery and don’t want to pursue surveillance, and for those [patients] we can deploy focal therapy, but it’s best studied in the older comorbid cohort.

What does the current evidence tell us about recurrence rates after focal therapy compared with surgical resection?

The recurrence rates following focal therapy depend on [tumor] size, anatomic location, and the experience and expertise of the interventional radiologist that’s doing the ablation. The one thing about ablation [is that] it does still have persistent enhancement. Following ablation, you can’t retreat, so that’s a fallback that we do have with ablation. In the plenary session [at AUA], I presented data from a large Canadian data set of over 2000 patients showing that recurrence rates are higher in ablation patients vs surgical patients, even though you would expect the ablation patients to have more indolent masses.

Where do the biggest evidence gaps currently lie and what are the notable future research directions in this area?

The biggest challenge is that we really don’t have prospective randomized data. It’s very hard to obtain, but that’s what the community should strive for, especially as we get new technologies such as histotripsy. That [technology] is exciting, but the dataset for that is very limited. [For example], we have data from [approximately] 70 patients in the HOPE4KIDNEY trial [NCT05820087] that just matured in 2025, and the company [HistoSonics] just submitted [the Edison Histotripsy System] for FDA approval.^1,2 As that technology hits our operating rooms, it would behoove us as a community to really figure out prospectively what’s superior [in terms of] ablation technique and how it compares with surgery.

References

1. The HistoSonics Edison system for treatment of primary solid renal tumors using histotripsy (#HOPE4KIDNEY) (#HOPE4KIDNEY). ClinicalTrials.gov. Updated December 22, 2025. Accessed June 10, 2026. https://clinicaltrials.gov/study/NCT05820087
2. HistoSonics moves to advance additional histotripsy applications announcing FDA submission for kidney tumors. News release. HistoSonics. May 11, 2026. Accessed June 10, 2026. https://www.businesswire.com/news/home/20260511268688/en/HistoSonics-Moves-to-Advance-Additional-Histotripsy-Applications-Announcing-FDA-Submission-for-Kidney-Tumors