Focal Therapy is a minimally invasive treatment modality for prostate cancer which aims to maintain oncological outcomes, while minimising the significant morbidity associated with radical prostatectomy and radiotherapy. ProFocal® (Medlogical Innovations, Sydney) is a focal laser ablation (FLA) treatment for localised prostate cancer. A Phase I clinical trial, ProFocal® Laser Therapy for Prostate Cancer Tissue Ablation (Australian New Zealand Clinical Trials Registry ID: ACTRN12618001774213p), was designed as an open-label, single-arm, safety and efficacy trial. In this study, we evaluate the oncological outcomes of ProFocal® treatment stratified by the anatomical location of the prostate cancer foci.

Between October 2020 to April 2023, 100 patients who met trial inclusion criteria were enrolled for ProFocal® treatment at Nepean Hospital, Sydney, Australia. Study Inclusion criteria were males over the age of 18 with biopsy confirmed intermediate risk prostate cancer, PSA≤15, Gleason score ≤7, clinical stage ≤T2c, and up to three tumour suspicious regions on multiparametric MRI. Patients were excluded if they had received prior treatment for their prostate cancer. The study protocol included a post-treatment MRI within the first week, and surveillance prostate biopsy at 3 months. Tumours were stratified by anatomical location from apex to base, and anterior to posterior.

The median age of study participants was 66 years (IQR 49-82), with a median pre-treatment PSA (ng/mL) level of 5.9 (0.7-15), and a prostate volume of 39cc (17-170). Median volume of focal lesion treated was 0.86 (0.12-1.78), and the majority of patients (78%) had ISUP 2 disease while the remaining 22% had ISUP 3 disease. Twenty-five (25%) patients were found to have clinically significant cancer on 3-month surveillance biopsy. However, an initial learning curve is evident, with surveillance of the first 50 cases finding disease in 17 patients (34%), decreasing to 8 (16%) in the subsequent 50 cases, of which only 3 (6%) of cases were in-field recurrences. When stratifying oncological outcomes by tumour location, 26 patients (26%) had anteriorly located cancer foci, with clinically significant in-field recurrences observed in 3 patients (11.5%). Among the 64 patients (64%) with posteriorly located cancer foci, 10 patients (15.6%) experienced clinically significant in-field recurrences.

ProFocal Treatment for Intermediate Risk Prostate Cancer is a promising treatment modality within the field of Focal Therapy. Following the initial learning curve associated with treatment delivery, detection of in-field clinically significant disease reduced to 6%. Stratified by tumour location, the recurrence rates were 11.1% to 11.8% for anterior tumours and 15.6% initially for posterior tumours, which decreased to 0%.