About half of the men receiving focal therapy for prostate cancer in the United States have disease that falls outside the group current guidelines support treating this way, according to a research letter in JAMA from researchers at the University of Pittsburgh.
Focal therapy targets only the part of the prostate containing cancer, using heat, cold, or laser energy, and leaves the rest of the gland intact. Its appeal is straightforward: compared with removing the whole prostate or irradiating it, it aims to spare urinary and sexual function. That appeal has driven adoption faster than the evidence supporting it has accumulated.
The practical consequence of weighing options is uncomfortable but useful. Being offered focal therapy does not by itself mean it is the right match for his cancer. In roughly half of cases nationally, it is being used in men whose disease profile the guidelines do not currently endorse for the procedure, either because the cancer may not need treating yet or because it may need more.
The Mismatch the Data Reveal
The investigators used the National Cancer Database, covering hospitals accredited by the Commission on Cancer, and examined 1,179,384 men aged 50 and older diagnosed with nonmetastatic prostate cancer between 2010 and 2023.
Focal therapy remained uncommon overall, accounting for 1.3 percent of the group. Among the 15,672 men who received it, 7,985, or 51.0 percent, had low, high, or very high-risk disease. The remaining 7,687, or 49.0 percent, had intermediate-risk disease, a category in which guidelines allow for carefully selected use.
The two ends of that mismatch carry opposite problems. Men with low-risk prostate cancer are generally candidates for active surveillance, monitoring rather than intervention, and treating them exposes them to procedure risks without a demonstrated survival benefit. Men with high or very high-risk disease may need treatment of the whole gland, and a targeted ablation risks leaving cancer behind.
Trends moved in encouraging directions for the more serious categories. Use in high-risk disease fell from 2.1 percent to 0.9 percent across the study period, and in very high-risk disease from 1.8 percent to 0.5 percent. Use in unfavorable intermediate-risk disease also declined, from 2.5 percent to 1.9 percent. Meanwhile, use rose in favorable intermediate-risk disease, from 2.1 percent to 2.9 percent. In low-risk disease, the rate edged up from 1.8 percent to 2.2 percent, a change that was not statistically significant.
The technology also changed substantially, the national analysis found. Cryotherapy accounted for 79.8 percent of these procedures at the start of the period and 19.1 percent by the end, while laser ablation rose from 14.6 percent to 45.8 percent and other approaches, including high-intensity focused ultrasound, climbed from 5.6 percent to 35.1 percent.
What the Guidelines Actually Say
Current American Urological Association and American Society for Radiation Oncology guidance directs clinicians to tell men with low- and intermediate-risk prostate cancer that whole-gland or focal ablation remains investigational, because high-quality data comparing ablation against surgery, radiation, and active surveillance are lacking. For high-risk disease, the guideline advises against ablation outside a clinical trial.
Investigational does not mean unsafe or unavailable. It means the long-term comparison against established treatments has not been completed.
Senior author Quoc-Dien Trinh, professor and chair of urology at the University of Pittsburgh School of Medicine, said in the university announcement that for appropriately selected intermediate-risk patients, focal therapy is an appealing option "because it aims to preserve quality of life." He added that understanding which patients are most likely to benefit becomes more important as these technologies spread.
MedicalDaily has previously reported on long-term focal therapy outcomes from a British study that found complication rates well below those of conventional treatment in selected patients. That work and this one are not in conflict. One examined outcomes in men chosen for the procedure; the other examined who actually gets it.
Where Patients Are Most Likely to Encounter This
In adjusted analysis, focal therapy was more likely among older men, men with low-risk disease, men with a greater burden of other health conditions, men with nonprivate insurance, and men treated at community facilities or at higher-volume centers.
That pattern is worth naming plainly. It suggests the men most likely to receive a procedure outside guideline support are often those with the least access to a second opinion from an academic multidisciplinary team, and those whose other health problems may already argue for surveillance rather than intervention.
The study cannot say whether any individual decision was wrong. Registry data do not capture tumor multifocality, patient preferences, or enrollment in trials and registries, and the researchers listed those omissions as limitations. The database also excludes procedures done outside accredited centers, which may understate total use, and it contains no information on long-term cancer outcomes, side effects, quality of life, retreatment rates or cost.
For men newly diagnosed, a few questions are worth asking before agreeing to any treatment. Which National Comprehensive Cancer Network risk group is my cancer in? What do the guidelines recommend for that group? Is active surveillance an option for me? If focal therapy is proposed, is it being offered inside a clinical trial or registry? What happens if cancer is later found in untreated tissue, and what would retreatment involve?
Nobody should stop or delay treatment based on a news article. A prostate cancer diagnosis is not usually an emergency, and there is almost always time to obtain a second opinion, ideally at a center that offers surgery, radiation, surveillance, and ablation, so the recommendation is not shaped by what is available. Medicare and most insurers cover second opinions, and cancer centers commonly have patient navigators who can help arrange one.
Key Questions Answered
What did the analysis find? Among 15,672 men who received focal therapy for nonmetastatic prostate cancer, 51 percent had low, high, or very high-risk disease, categories outside current guideline-supported use. The other 49 percent had intermediate-risk disease.
Is focal therapy dangerous? The study did not measure harm. It measured whether patient selection matched guidelines. The concern is undertreatment in high-risk men and unnecessary treatment in low-risk men who could be monitored instead.
What is focal therapy? A procedure that destroys only the cancerous portion of the prostate using cold, heat, laser or focused ultrasound, preserving the rest of the gland to protect urinary and sexual function.
Why do guidelines call it investigational? Because high-quality trials comparing its long-term cancer outcomes against surgery, radiation, and active surveillance have not been completed.
Which men were most likely to receive it? Older men, men with low-risk disease, men with more coexisting health conditions, men with nonprivate insurance, and men treated at community or higher-volume facilities.
What should a newly diagnosed man ask? Which risk group the cancer falls into, what guidelines recommend for that group, whether active surveillance applies, whether any ablation is offered within a trial, and what retreatment would involve.
Should anyone who already had focal therapy be worried? Not on the basis of this study. It reports national patterns, not individual outcomes. Follow-up plans and any concerns belong with the treating urologist.
