Editorial Comment on: “Real-World Safety of Prostate Cancer Focal Therapy: MAUDE Database Analysis” by Qian et al.

As the adoption of ablative technologies to achieve focal therapy for prostate cancer continues to increase across the United States and globally, it is imperative to understand and mitigate risks of these treatments in order to ensure that these interventions provide a reassuring safety profile while effectively addressing the goal of oncologic control. Qian and colleagues should be applauded for their article investigating the reported complications from the use of HIFU, cryoablation, laser ablation, and IRE in the treatment of prostate cancer. ¹ This work helps to provide our discipline with critical insights into the safety profile of these ablative technologies when used as prostate cancer treatments, enriching the discussions between physicians and patients when planning for treatment.

The aforementioned focal therapies are often sought out by men who wish to actively treat their prostate cancer but wish to maximize preservation of quality-of-life measures by minimizing possible side effects of their treatment. ² While these treatment options can certainly be attractive to this patient population when appropriately selected, it is imperative that providers continue to counsel their patients on the full spectrum of therapeutic risks that can be life-altering for any technique, whether imparting whole gland or focal therapy approaches to care. ³ Reassuringly, findings from the MAUDE Database demonstrates that the vast majority of reported complications were minor, Clavien–Dindo grades 1 or 2. ¹ However, it is notable that the data evaluated, which was queried and analyzed for these specific technological approaches to ablation with a prostate cancer indication, did not specifically differentiate those cases which received focal therapy vs whole gland ablation. It is reasonable to surmise that the subset of cases that underwent subtotal gland ablation would be even less likely to experience procedure-related complications, particularly higher-grade complications such as rectal fistulas.

Among the more serious adverse events represented in this report, “rectal fistula” was reported as a complication for each of the four treatment modalities queried, but represented nearly 40% of documented HIFU-related complications, though an overall incidence risk was not reported. ¹ The true incidence of fistula formation in patients undergoing HIFU for the treatment of prostate cancer, including whole gland therapies, is most commonly reported in the range of only 0%–3% across multiple other published studies, most commonly reported at <1%. ^{4 –6} This emphasizes the inherent limitation of the MAUDE Database not reporting the denominator of cases performed during the period of complication reporting to assess incidence rates. Another limitation noted in the report was the lack of longitudinal patient outcomes that could provide vital and much desired information when counseling patients. Despite this, patients should always be made aware of the potential for severe complications as a part of the informed consent process, and the data summarized by Qian et al. should help clinicians frame these discussions with their patients while counseling on prostate cancer ablative options. We commend this group for sharing their insights into the safety profiles of these newer ablative therapies and emphasis on patient-centered planning of prostate cancer treatment.