TOPLINE

A retrospective study provides the largest contemporary analysis of long-term outcomes of focal therapy in patients with nonmetastatic prostate cancer, reporting low 10-year cancer-specific mortality (0.13%) and metastasis rates (3.3%) among the nearly 3500 patients who received focal therapy using high-intensity focused ultrasound (HIFU) or cryotherapy.

METHODOLOGY

• Long-term outcome data for focal therapy using HIFU or cryotherapy to treat nonmetastatic prostate cancer remain limited.
• The current analysis included 3477 patients with nonmetastatic prostate cancer who underwent primary focal HIFU (n = 2897) or cryotherapy (n = 580) with at least 6 months of follow-up.
• Patients were identified from prospectively maintained HEAT and ICE registries across 14 UK centers between 2004 and 2024. Most had favorable intermediate-risk (48%), unfavorable intermediate-risk (23%), or high-risk disease (25%) according to European Association of Urology risk criteria.
• The intervention included up to two focal ablative sessions. The primary outcome was cancer-specific mortality; secondary outcomes included all-cause mortality, metastasis development, local retreatment, and radical treatment.
• Researchers conducted intention-to-treat and per-protocol analyses for local retreatment and radical treatment outcomes. Median follow-up for patients alive at last follow-up was 3.3 years, with 1118 patients having ≥ 5 years of follow-up and 173 having ≥ 10 years of follow-up.

TAKEAWAY

• The estimated 10-year cancer-specific mortality was 0.13%, with two prostate cancer deaths occurring among the 3477 patients treated with focal therapy.
• The 10-year cumulative incidence of metastasis was 3.3% (42 events), and all-cause mortality was 12% (101 events).
• In the intention-to-treat analysis, 10-year local retreatment was 33% (414 events) and radical treatment was 30% (373 events). In per-protocol analysis, rates were 13% (139 events) and 8.9% (99 events), respectively.
• In the landmark analysis of 426 patients with at least 7 years of event-free follow-up, there were no prostate cancer-specific deaths, and 10-year cumulative incidence of metastasis was only 0.45% (1 event).

IN PRACTICE

“Focal therapy using up to two sessions of focal HIFU or cryotherapy could be considered as a first-line treatment for well-selected patients of nonmetastatic prostate cancer alongside radical treatment,” study authors concluded.

However, outside experts commenting through the Science Media Centre emphasized that the observational findings should not be interpreted as evidence that focal therapy is equivalent to radical treatment.

Freddie Hamdy, professor of urology and head of the Nuffield Department of Surgical Sciences, University of Oxford, Oxford, England, explained that “caution must be exercised before recommending focal therapy as standard of care in the management of localized prostate cancer” based on these findings.

Alastair Lamb, clinical reader at the Barts Cancer Institute, St Bartholomew’s Hospital, London, England, commented that, while the registry study shows that focal therapy is safe, it “doesn’t show that it works compared to standard of care radical treatment (prostatectomy and radiotherapy) which have RCTs [randomized controlled trials] showing their efficacy in long-term survival outcomes.”

“We eagerly await the results of the PART Trial, the first and only large [RCT] comparing focal vs radical therapy in prostate cancer that needs treatment — until then focal therapy remains a very promising experimental treatment,” Lamb added.

SOURCE

The study, led by Alexander Light, Imperial Prostate, Department of Surgery and Cancer, Imperial College London, London, was published online on July 11 in European Urology.

LIMITATIONS

The observational design and lack of a radical treatment comparator are major limitations. Registry data are also subject to biases from missing data and right-censoring. Clinical practice, including patient selection, treatment delivery, and follow-up, likely varied across institutions and evolved over time, potentially influencing outcomes. The use of additional local treatments and androgen deprivation therapy (ADT) was not standardized, and the reasons for these treatment decisions, including whether ADT was combined with other systemic therapies, were not recorded. Relatively few patients had 10 years of follow-up, although long-term outcomes were estimated using time-to-event analyses.

DISCLOSURES

The HEAT registry received support from an unrestricted grant provided by Sonablate. Hamdy reported being an investigator on the National Institute for Health and Care Research’s PART Trial, an advisor for Evidence Generation Group and Intuitive Surgical, and a lecturer for Pfizer, Ipsen, and Recordati. Lamb reported receiving educational support from Intuitive Surgical, BXT Accelyon, GSK, Astellas, Lilly, AstraZeneca, and Ipsen. Other disclosures can be found here.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.