Focal Therapy (FT) has become an increasingly recognised treatment modality for localised prostate cancer. FT aims to spare patients from side effects which compromise quality-of-life, such as erectile dysfunction and urinary incontinence, while maintaining oncological outcomes. Different regions of the prostate are associated with unique treatment challenges. Specific to apical prostate cancers are the potential risk of injury to the urethral sphincter. ProFocal® (Medlogical Innovations, Sydney) is a novel, cooled focal laser ablation system developed for curative treatment of localised prostate cancer. The aim of this study is to report the oncological, functional and safety outcomes of FLA of apical prostate cancers using the ProFocal® system.

A retrospective subset analysis of patients with apical cancers was conducted using data from a prospective trial cohort. The PFLT-PC (ProFocal Laser Therapy for Prostate Tissue Ablation) trial (Australian New Zealand Clinical Trials Registry ID: ACTRN12618001774213p) is a prospective, institutional review board approved trial evaluating the novel ProFocal® device (Medlogical Innovations, Sydney, Australia) at Nepean Hospital, Australia for localised prostate cancer. Inclusion criteria were men with prostate cancer with PSA ≤15 ng/mL, stage ≤T2c, ISUP 2–3, and 1–2 MRI visible lesions which were concordant with biopsy results. Following ProFocal treatment, patients underwent a post-treatment MRI within 72 hours, and a 3-month follow-up transperineal prostate biopsy to assess treatment efficacy. Functional outcomes were measured using validated questionnaires (IPSS, SHIM, EPIC, SF-12) at baseline, 3, 6, and 12 months. Statistical analysis was performed using SPSS 29.0. The Friedman test was performed to analyse differences between related non-parametric variables across multiple time points.

From the trial cohort of 100 men who underwent FLA, 32 patients were identified and included in the analysis, having completed a 3-month surveillance biopsy and at least 12 months of follow-up. All cases were completed as day only procedures, with no significant peri- or post-operative complications (Clavien-Dindo 3+). On 3-month surveillance biopsy, only 1 (3.1%) patient had evidence of clinically significant prostate cancer, with ISUP 2 disease in a single core, on their in-field biopsies only. Patient reported functional outcomes were excellent with no significant changes across all domains.

Treatment of apical prostate cancers with the ProFocal® system demonstrated excellent oncological, functional outcomes and safety profile. On surveillance biopsy, 96.9% of patients demonstrated successful infield treatment of disease, and functional outcomes were excellent across all domains, with no significant worsening in urinary, bowel, quality of life or sexual reported outcome measures.