Focal therapy for prostate cancer frequently used outside guideline-supported groups

Approximately half of focal therapy procedures for nonmetastatic prostate cancer occurred in patients with low-, high-, or very-high risk disease, according to findings from a national US database published in a research letter in JAMA.¹

According to the authors, the findings underscore the importance of patient selection for a treatment approach that remains investigational, as routine use of focal therapy in these settings is not supported by contemporary guidelines.

Current AUA/ASTRO guidelines state that patients with low- and intermediate-risk disease should be counseled that that whole gland or focal ablation is investigational, and high-quality data comparing focal therapy with standard of care therapies are lacking.² The guideline also recommends against whole gland or focal ablation for patients with high-risk disease outside a clinical trial setting.

Related: The AUA Clinically Localized Prostate Cancer guideline: FAQs for urologists

"For appropriately selected patients with intermediate-risk disease, focal therapy is an appealing treatment option because it aims to preserve quality of life while treating the cancer," said senior author Quoc-Dien Trinh, MD, MBA, professor and chair of the Department of Urology at the University of Pittsburgh School of Medicine, in a news release on the findings.³ "But as promising new technologies become more widely available, it is important to understand which patients are most likely to benefit so that treatment decisions are guided by evidence and aligned with clinical guidelines."

National patterns of focal therapy use

The investigators used the National Cancer Database (NCDB) to examine patterns and temporal trends in focal therapy use according to National Comprehensive Cancer Network (NCCN) risk group. Patients with missing or unknown clinical N or M stage, insufficient information to assign an NCCN risk group, or age younger than 50 years were excluded.

The analysis included 1,179,384 men aged 50 years or older with nonmetastatic prostate cancer diagnosed from 2010 through 2023 at US Commission on Cancer–accredited centers. Focal therapy accounted for 1.3% of the overall study population. Of the 15,672 patients who received focal therapy, 7985 (51.0%) had low-, high-, or very-high-risk disease, whereas 7687 (49.0%) had intermediate-risk disease.

The investigators also found that the use of focal therapy differed over time.

Among patients with low-risk disease, focal therapy rates did not change significantly from 2010 to 2023, increasing from 1.8% to 2.2% (P = .46 for trend). Focal therapy use increased significantly among patients with favorable intermediate-risk disease, from 2.1% to 2.9%, while declining among those with unfavorable intermediate-risk disease, from 2.5% to 1.9%. Rates also decreased among patients with high-risk disease, from 2.1% to 0.9%, and very-high-risk disease, from 1.8% to 0.5% (P < .001 for trend for each group).

The types of focal therapy also changed substantially. Cryotherapy accounted for 79.8% of focal therapy procedures in 2010 but 19.1% in 2023. During the same period, laser ablation increased from 14.6% to 45.8%, while other tumor destruction approaches, including high-intensity focused ultrasound (HIFU), increased from 5.6% to 35.1%.

In multivariable analysis, adjusted predicted probabilities of focal therapy were higher among older patients, those with low-risk disease, those with greater comorbidity burden, those with nonprivate insurance, and those treated at community facilities or higher-volume centers.

The investigators acknowledged several limitations of the NCDB analysis. Focal therapy performed outside Commission on Cancer–accredited centers may not have been captured, potentially resulting in an underestimate of its use. The database also does not provide information on long-term oncologic outcomes, toxicity, quality of life, retreatment, or treatment costs. In addition, information on tumor multifocality, patient preferences, and clinical trial or registry participation were unavailable.

According to the authors, “These findings underscore the importance of distinguishing selective investigational use from routine adoption of focal therapy ahead of appropriate evidence.”

Trinh also concluded in the news release,² “Our main goal is to ensure that each patient receives the treatment that best matches the characteristics of their cancer and their individual needs.”

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