Cooled laser focal therapy shows promise for localized prostate cancer

The phase 2 PFLT-PC trial reported favorable oncologic and functional outcomes following cooled laser focal therapy (cLFT) with the ProFocal device, supporting the safety and efficacy of this approach for the management of localized prostate cancer.¹

The findings were published in BJU International.

The ProFocal Device is designed to directly target the cancer while sparing the surrounding prostate tissue. According to the authors, “There is direct, real-time temperature monitoring of the prostate tissue ([utilizing] a temperature monitor present at the tip of the ablation device), which helps provide more reliable and reproducible ablation parameters than other existing LFT systems.”

“This new technology is very promising with excellent cancer control while preserving patients’ quality of life,” said lead author Jonathan Kam, MD, of Nepean Hospital, Australia, in a news release on the findings.² “Traditional radical prostatectomy and radiotherapy for prostate cancer results in very high rates of incontinence and erectile dysfunction. With this new technology, patients can have their prostate cancer treated with very low risk of suffering the [adverse] effects associated with traditional prostate cancer treatments.”

In total, the study included 100 patients with localized prostate cancer who underwent the cLFT procedure under general anesthesia as a day procedure. To be eligible for enrollment, patients needed to have a prostate-specific antigen (PSA) level of 15 ng/mL or lower, T stage ≤T2c, and ISUP score 2 to 3 concordant with multiparametric MRI (mpMRI). The median age of patients was 66 years (IQR, 60 to 72).

The primary outcome measures for the study were the adequacy of tissue ablation per mpMRI within 72 hours and biopsy at 3 month follow-up. Secondary outcomes included functional measures using the International Prostate Symptom Score (IPSS), Sexual Health Inventory for Men (SHIM), Expanded Prostate Cancer Index Composite (EPIC), and the 12-item Short-Form Health Survey. The investigators also assessed adverse events (AEs) within 90 days of the procedure.

Overall, the median treatment time was 60 minutes (IQR, 47 to 70).

Oncological results were promising, with 77% of patients having no ISUP grade group 2 or higher prostate cancer on any of their treatment biopsies. Additionally, 84% of men showed no ISUP grade group 2 or higher prostate cancer on 3-month treatment zone biopsies.

Erectile dysfunction was reported in 12% of men at the 3-month follow-up assessment. The mean reduction in SHIM and EPIC-sexual domain scores was 15%. There was also a 4.5% decline in EPIC-urinary domain scores, although the investigators noted no change in IPSS. Further, no differences were found in bowel functional outcomes nor quality of life outcomes.

In total, 6% of patients experienced an AE at the time of treatment, and 28% reported an AE at 3 months following treatment. The majority of AEs were grade 1 to 2, with 1 grade 3 AE reported. The most common AEs were hematuria (15%) and erectile dysfunction (12%).

“Our study showed that cLFT provides similar oncological outcomes to existing literature on other FT devices but with an improved safety profile with no fistulae and low rates of incontinence,” the authors concluded. “Compared to previous studies on [radical prostatectomy], cLFT has lower rates of incontinence and erectile dysfunction, but long-term follow-up is required to assess the long-term oncological and functional outcomes in patients treated with cLFT.”

REFERENCES

1. Kam J, Hanna B, Jackson S, et al. Focal therapy using a novel cooled laser device for prostate cancer: early trial results. BJU Int. 2026. doi: 10.1111/bju.70150

2. Novel laser therapy device generates promising results in prostate cancer clinical trial. News release. Wiley. January 28, 2026. Accessed January 29, 2026. https://www.eurekalert.org/news-releases/1113899