ProFocal Cooled Laser Therapy Demonstrates 84% Local Control Rate in Prostate Cancer Phase 2 Trial
Key Insights
The PFLT-PC phase 2 trial showed 84% of patients had no clinically significant prostate cancer (search) on biopsy at 3 months following ProFocal (search) cooled laser focal therapy (search) treatment.
The therapy demonstrated a favorable safety profile with only 1% incontinence (search) rate and 12% erectile dysfunction (search), significantly lower than traditional radical prostatectomy.
The single-center study enrolled 100 patients with localized prostate cancer (search) eligible for focal therapy, with median age 66 years and PSA 5.9 ng/mL.
A novel cooled laser focal therapy (search) device has demonstrated promising early results for treating localized prostate cancer (search), with 84% of patients showing no clinically significant disease on follow-up biopsy, according to findings from the phase 2 PFLT-PC trial published in BJU International.
The ProFocal (search) device achieved local disease control in the majority of patients while maintaining a favorable safety profile compared to traditional whole-gland treatments. In the study, 84% of enrolled patients had no clinically significant prostate cancer (search), defined by an International Society of Urological Pathology (ISUP) score of less than 2, on in-field biopsy at 3 months after the procedure. Additionally, 77% of patients had no ISUP score of 2 or greater in any of their post-treatment biopsies.
Study Design and Patient Population
The single-center, open-label PFLT-PC trial enrolled 100 patients with prostate cancer (search) who were eligible for focal therapy. Inclusion criteria included a PSA level of 15 ng/mL or less, clinical stage T2c disease or lower, ISUP grade 2 or 3 prostate adenocarcinoma, and at least 2 suspicious tumor regions with no evidence of extracapsular extension.
The median patient age was 66 years (IQR, 60-72), with a median prostate-specific antigen (PSA) level of 5.9 ng/mL (IQR, 3.9-7.6). The median lesion volume was 0.84 mL (IQR, 0.57-1.2), and the median number of prostate biopsy cores taken was 26 (IQR, 21-34). Most patients had ISUP grade 2 disease (78%), tumors on the posterior axial plane (64%), and tumors on the middle sagittal plane (67%).
Safety and Functional Outcomes
The cooled laser focal therapy (search) demonstrated a notably improved safety profile compared to traditional treatments. Safety data indicated low rates of incontinence (search) (1%) in the first 3 months after therapy. The most common adverse events included hematuria (search) (14%), erectile dysfunction (search) (12%), and voiding dysfunction (11%). No deaths were observed in the trial.
Regarding functional outcomes, a 4.5% decrease in urinary function was found based on Expanded Prostate cancer (search) Index Composite (EPIC)-urinary domains (P = .03), but there was no change in the International Prostate Symptom Score (IPSS). No significant differences in bowel functional or quality of life outcomes were observed. A mean reduction of 15% was observed in the Sexual Health Inventory for Men (SHIM) and EPIC-sexual domain scores (P < .001; P < .001).
Following the procedure, 19 patients had indwelling catheters placed, primarily as a precautionary measure, due to hematuria (search) and retention in 1% and 2% of patients, respectively.
Clinical Significance and Comparative Outcomes
"The PFLT-PC trial demonstrates the safety and efficacy of [prostate cancer (search)] treatment with the [ProFocal (search)] device. Our study showed that [cooled laser focal therapy (search)] provides similar oncological outcomes to existing literature on other [focal therapy] devices but with an improved safety profile with no fistulae and low rates of incontinence (search)," wrote Jonathan Kam, MD, FRACS, urologist at Nepean Hospital (search) and Sydney Medical School (search) in Sydney, New South Wales, Australia, along with study coinvestigators.
The researchers noted that compared with previous studies on robot-assisted radical prostatectomy, cooled laser focal therapy (search) demonstrated lower rates of incontinence (search) and erectile dysfunction (search), though they emphasized that long-term follow-up is required to assess the long-term oncological and functional outcomes in patients treated with this approach.
The primary endpoint of the study was the adequacy of tumor ablation, while safety endpoints included outcomes of functional and quality of life measures. The results suggest that cooled laser focal therapy (search) may offer an effective treatment option for patients with localized prostate cancer (search) who are candidates for focal therapy, potentially providing similar cancer control with reduced treatment-related morbidity.