Initial experience of the first inhuman trial of focal laser ablation (ProFocal-Rx®) for localised prostate cancer: assessment of urinary functional outcomes
Jonathan KAM1, 2, 3, George MCCLINTOCK1, 3, Joshua MAKARY1, 2, 3, Alice GRANT 1, 3, Mohan ARIANAYAGAM 1, 2, 3, Bertram CANAGASINGHAM 1, 2, 3, Richard FERGUSON1, 2, 3, Ahmed GOOLAM 1, 2, 3, Nicola JEFFERY 1, 2, 3, Mohamed KHADRA 1, 2, 3, Raymond KO 1, 2, 3, Nicholas MEHAN 1, 3, Isaac THANGASAMY 1, 2, 3, Matthew WINTER 1, 2, 3, Celalettin VAROL 1, 2, 3
1 Nepean Urology Research Group, Kingswood, Australia
2 Sydney Medical School, University of Sydney, Australia
3 Nepean Hospital, Kingswood, Australia
Aim: To evaluate the functional urinary outcomes for men treated with focal laser ablation for localised prostate cancer.
Methods: A prospective trial was performed evaluating focal laser ablation for localised prostate cancer using the novel ProFocal-Rx™ device (Medlogical Innovations, Sydney, Australia) at Nepean Hospital, NSW, Australia. Institutional review board was approved by the Nepean Blue Mountains Human Research Ethics Committee. Inclusion criteria included men with prostate cancer with a PSA ≤15 ng/ml, stage ≤T2c, ISUP 2-3, and 1-2 MRI visible lesions which were concordant with biopsy results. Urinary functional outcomes were assessed with the International Prostate Symptom Score (IPSS) and Expanded Prostate Cancer Index Composite scores – urinary domains (EPIC) prior to focal laser ablation and at 3 months post treatment. Data analysis was performed using SPSS 24.0.
Results: The first forty-one men recruited for this trial who underwent focal laser ablation and have reached their 3-month follow-up were included in this analysis. The median age was 69, PSA 6 (range 0.7-15) and MRI lesion volume 0.82cc (range 0.12-3.76).
Pre-treatment, the median IPSS score was 6.5 (mild symptom score) with a range of 0-19. At 3 months there was no significant change in the IPSS score – median 7 (range 0-21), p=0.43. There was also no significant difference between the pre-treatment and 3-month post-treatment EPIC- urinary domain score (median 88.5 vs. 85.9, p=0.23)
Conclusion: Our initial experience with the novel focal laser ablation of prostate cancer shows that urinary function is preserved. This represents a major improvement compared to the current radical treatments available for prostate cancer which result in a significant effect on men’s urinary function.