Introduction: ProFocal-Rx™ (Medlogical Innovations, Sydney, Australia) is a novel, day-only, fast focal laser ablation treatment for prostate cancer. It is performed via a transperineal route and can be utilised with an MRI/US fusion targeting platform. Compared to other focal therapies available it provides precise tissue ablation with very minimal energy spread to surrounding tissues. We aimed to evaluate the interim outcomes of this novel treatment for localised prostate cancer. Methods: A prospective trial was performed following institutional review board evaluating day only, fast, focal laser ablation for localised prostate cancer using the novel ProFocal-Rx™ device (Medlogical Innovations, Sydney, Australia) at Nepean Hospital, Australia. Inclusion criteria included 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. A post treatment MRI was performed within 72 hours to confirm adequacy of tissue ablation. Patients then had a 3-month follow-up transperineal prostate biopsy to assess treatment outcomes. Results: The interim, non validated data for the 100 men recruited for this trial who underwent focal laser ablation and had a minimum of 3 months follow-up were included in the analysis. The median age was 69, PSA 6ng/ml (range 0.7-15) and MRI lesion volume 0.82cc (range 0.12-3.76). All cases were completed as day only procedures and there were no readmissions to hospital. On the 3 month follow-up biopsy, 75% of patients had no evidence of ISUP 2 or greater prostate cancer on any of their biopsies. 12% of cases proceeded to salvage robotic radical prostatectomy and 2% underwent salvage radiotherapy. 40% of cases with ISUP 2 prostate cancer on the 3-month biopsy were placed under active surveillance due to the small volume of cancer detected on these biopsies. Of the cases who underwent salvage robotic prostatectomy there was no significant difference in their outcomes compared to our contemporary cohort with nerve sparing achievable for cases and a median blood loss of 250ml. Patient reported functional outcomes were excellent with no significant worsening in quality-of-life scores (SF-12), lower urinary tract symptoms (IPSS, EPIC- urinary domains) or sexual function (SHIM and EPIC-sexual domains) between the pre-op, 3-month or 6-month assessment Conclusions: The interim results from the ProFocal-Rx™ focal laser ablation trial are promising with 85% of patients avoiding radical treatment. For patients requiring salvage surgery there appears to be no increase in adverse outcomes due to prior focal treatment. Functional outcomes are excellent with no worsening in any patient reported outcomes post treatment. SOURCE OF Funding: Medlogical Innovations sponsored this study
