About half of the men who received focal therapy for prostate cancer in the United States over the past decade fell outside the risk groups that current treatment guidelines support for the procedure, according to a national analysis published in JAMA. Some were treated more aggressively than their cancer warranted. Others had diseases for which guidelines say focal therapy should not be used at all outside a clinical trial.
For men currently weighing treatment options, the finding is not a warning about the technique itself. It is a warning about matching. Focal therapy is a genuinely appealing option for the right patient, and the study's senior author said as much. The question the data raise is whether the men receiving it are the men most likely to benefit.
The analysis covered 1,179,384 men aged 50 and older diagnosed with nonmetastatic prostate cancer between 2010 and 2023 at Commission on Cancer-accredited centers.
The Numbers Behind the Mismatch
Focal therapy remains uncommon. It accounted for 1.3 percent of the study population overall, or 15,672 men.
Within that group, 7,985 patients, or 51 percent, had low-risk, high-risk, or very high-risk disease. The remaining 7,687, or 49 percent, had intermediate-risk disease, the category where guidelines see a potential role.
Current AUA and ASTRO guidelines advise clinicians to inform patients with low- and intermediate-risk disease that whole-gland or focal ablation remains investigational because high-quality data comparing it with surgery, radiation, and active surveillance are lacking. For high-risk disease, the guidance is firmer: clinicians should not recommend focal ablation outside a clinical trial.
The pattern is moving in different directions depending on the group. Among men with favorable intermediate-risk disease, focal therapy use rose from 2.1 percent in 2010 to 2.9 percent in 2023. Among unfavorable intermediate-risk patients, it fell from 2.5 percent to 1.9 percent, among high-risk patients from 2.1 percent to 0.9 percent, and among very high-risk patients from 1.8 percent to 0.5 percent. Use in low-risk disease did not change significantly, moving from 1.8 percent to 2.2 percent.
Read together, that suggests the field is narrowing its use at the aggressive end while the low-risk end has held steady, and low-risk prostate cancer is precisely where active surveillance is the preferred approach.
The technology itself has turned over, according to a summary of the analysis. Cryotherapy accounted for 79.8 percent of focal procedures in 2010 but 19.1 percent in 2023, while laser ablation rose from 14.6 percent to 45.8 percent and other approaches, including high-intensity focused ultrasound, rose from 5.6 percent to 35.1 percent.
Focal therapy destroys the portion of the prostate containing the tumor while leaving surrounding tissue intact. It sits between doing nothing immediately and treating the whole gland. Active surveillance monitors low-risk cancer with periodic testing and biopsy. Radical prostatectomy removes the prostate, and radiation treats the whole gland, both carrying meaningful risks of erectile dysfunction and incontinence.
The appeal of focal therapy is its aim to control cancer while preserving function. The problem is that long-term comparative evidence does not yet exist, which is why guidelines call it investigational rather than a fourth-standard option.
Where the Discordance Concentrates
The analysis identified specific patterns in who receives focal therapy. Adjusted predicted probabilities were higher among older patients, men with low-risk disease, men with greater comorbidity burden, men with nonprivate insurance, and men treated at community facilities or at higher-volume centers.
Two deserve attention. Older men with more health problems may be steered toward focal therapy as a gentler alternative, but for low-risk disease, the alternative guidelines actually endorse is surveillance, not ablation. The community facility signal suggests that where a man is treated may influence what he is offered as much as what his biopsy shows.
Separate work using a different national database has found that men with high-risk disease treated with focal therapy had higher cancer-specific mortality than comparable men who underwent radical prostatectomy, and its authors concluded the practice should be discouraged in that group.
Quoc-Dien Trinh, professor and chair of urology at the University of Pittsburgh School of Medicine and the study's senior author, said in a university news release that for appropriately selected intermediate-risk patients, focal therapy "aims to preserve quality of life while treating the cancer."
He added that as new technologies become widely available, understanding which patients are most likely to benefit ensures treatment decisions are guided by evidence and aligned with guidelines.
The Limits of What This Study Can Tell Patients
This is a research letter drawing on the National Cancer Database, and its authors were direct about what it cannot answer.
The database captures care at Commission on Cancer-accredited centers. Focal therapy performed elsewhere, including at freestanding centers that market these procedures directly to patients, may not be counted, meaning true use is likely underestimated.
The analysis also contains no information on long-term cancer outcomes, side effects, quality of life, retreatment rates, or costs. It does not tell us how these men fared. It tells us who was treated.
Missing as well are tumor multifocality, patient preferences, and whether a man was enrolled in a clinical trial or registry. Some procedures counted as discordant may have occurred within research protocols that guidelines permit.
The authors framed the takeaway as "distinguishing selective investigational use from routine adoption" in the absence of appropriate evidence. That is a statement about how a technology enters practice, not a claim that any individual patient was harmed.
Nothing in this analysis changes existing guidance. Men already treated with focal therapy should continue their scheduled follow-up rather than reading this as a signal that something went wrong.
Questions Worth Asking Before Choosing Treatment
Men newly diagnosed can use this finding practically. Ask which NCCN risk group the cancer falls into, whether low, favorable intermediate, unfavorable intermediate, high or very high risk. That single answer determines which options guidelines support.
Ask whether active surveillance is appropriate, particularly for low risk disease, and ask why if the answer is no. Ask whether a proposed focal procedure is being offered inside a clinical trial or registry, and if not, ask what evidence supports it for that specific risk group.
A second opinion at an academic center is reasonable for any prostate cancer treatment decision and is generally covered by insurance. Prostate cancer usually allows time to seek one.
The AUA and ASTRO issued a guideline amendment in 2026, and future updates will incorporate accumulating focal therapy data. Prospective studies reporting oncologic and functional outcomes, rather than database analyses of who received what, are what will eventually settle the question.
Key Questions Answered
What is focal therapy for prostate cancer?
A treatment that destroys the part of the prostate containing the tumor while sparing the rest of the gland, using energy sources such as laser, cryotherapy, or high-intensity focused ultrasound.
Which patients do the guidelines support?
AUA and ASTRO guidance describe focal ablation as investigational for low- and intermediate-risk disease and recommend against it for high-risk disease outside a clinical trial.
Does this study mean patients were harmed?
No. The analysis measured which risk groups received the procedure. It contains no data on cancer outcomes, side effects, retreatment, or quality of life.
Why would a man with low-risk cancer receive focal therapy?
The study found higher use among older men, those with more health conditions, and those treated at community facilities. For low-risk disease, guidelines generally favor active surveillance.
Should a man already treated with focal therapy be worried?
No. Continue scheduled follow-up and raise any questions with the treating urologist. This analysis does not change individual care plans.
What should a newly diagnosed man ask his doctor?
Which NCCN risk group the cancer falls into, whether active surveillance is appropriate, and whether any proposed focal procedure is part of a clinical trial or registry.
Is focal therapy covered by insurance?
Coverage varies by payer, procedure type, and risk group. Patients should verify coverage in writing before scheduling, since investigational designations can affect payment.
