Initial experience of the first inhuman trial of focal laser ablation (ProFocal-Rx®) for localised prostate cancer: Is PSA sufficient for follow-up?
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 if PSA is sufficient for follow-up of patients 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 PSA ≤15 ng/ml, stage ≤T2c, ISUP 2-3, and 1-2 MRI visible lesions which were concordant with biopsy results. PSA and transperineal prostate biopsy were performed 3 months post-treatment.
Results: The first forty-one men recruited for this trial who underwent focal laser ablation and follow-up PSA and biopsy were analysed. The median age was 69, PSA 6 (range 0.7-15) and MRI lesion volume 0.82cc (range 0.12-3.76).
At 3 months, 26 men (63%) had a decrease in PSA (median 39% decrease, range 9-82% decrease), 13 men had an increase in PSA (median 40% increase, range 22%-340% increase), 1 man had no change in his PSA level. In patients who had prostate cancer detected on the 3-month post-treatment biopsy, 37% had an increase in PSA, while 63% had a decrease in PSA levels.
Conclusion: PSA alone is not a good indicator of treatment response following focal laser ablation for localised prostate cancer. A biopsy is currently required to monitor for treatment outcomes.