Initial experience of the first inhuman trial of focal laser ablation (ProFocal-Rx®) for localised prostate cancer: assessment of sexual function 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 sexual function outcomes for men treated with the novel 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. Sexual function outcomes were assessed with the Sexual Health Inventory for Men (SHIM) and Expanded Prostate Cancer Index Composite scores – sexual 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, most men had mild-moderate erectile dysfunction, with a median SHIM score of 15.7 (range 5-25). At the 3 months post treatment there was no significant change in SHIM scores, median 14.3, p=0.08. There was a small decrease in the EPIC- sexual domain scores at the 3-month post-treatment assessment (median 56.1 vs. 48.2, p=0.003). Prior to treatment 5 men were taking PDE-5 inhibitors for erectile dysfunction. Of the remaining 36 men, only 3 commenced medications for erectile dysfunction at the 3-month assessment.
Conclusion: Our initial experience with the novel focal laser ablation of prostate cancer shows that sexual function is mildly affected for a small proportion of men undergoing this treatment. This represents a major improvement compared to the current radical treatments available for prostate cancer which result in a significant effect on men’s sexual function.