Focal laser ablation (FLA) is an emerging, minimally invasive treatment for localised prostate cancer. ProFocal® device (Medlogical Innovations, Sydney, Australia) is a novel, cooled, focal laser ablation device for prostate cancer with the pivotal PFLT-PC study completed in 2023. We aimed to assess the real-world oncological outcomes in patients undergoing FLA with the ProFocal® device.

Following the completion of the PFLT-PC trial, we established a prospective database tracking patients treated with the ProFocal® device across four institutions in Australia. Inclusion criteria were PSA ≤15 ng/mL, clinical stage ≤T2c, ISUP 2–3, and one or two MRI-visible lesions concordant with biopsy findings. Treatment success was assessed by transperineal biopsy at 3 months post-procedure.

The data from 87 patients with a total of 97 MRI-biopsy concordant lesions were analysed. The median age was 67 years (IQR 62–74), PSA 6.0 ng/mL (IQR 4.1–7.1), prostate volume 42cc (IQR 32–57) and MRI lesion volume 0.90cc (IQR 0.5 – 1.35). All cases were completed as day only procedures. Median treatment duration was 57.4 minutes (IQR 45–75), involving a median of 8 ablations (IQR 7–10) across 4 locations (IQR 3–5). PSA significantly decreased at 3 months, with a median reduction of 1.05 ng/mL (IQR 0.0–3.4; p < 0.001). Follow-up biopsies identified residual cancer (ISUP ≥2) in 17 of the patients. Four patients with infield residual cancer also had ISUP ≥2 in their outfield biopsies, thus overall true treatment failure occurred in 15% of patients.

FLA using the ProFocal® device provides promising oncological outcomes in a multi-centre, real world Australian context, achieving successful infield ablation in 85% of patients with a treatment duration of under one hour, highlighting its efficiency and clinical value.