The rate of 6-month clinically significant prostate cancer after treatment with high-frequency irreversible electroporation (H-FIRE) ablation was lower than the historical control using other energy platforms, according to a study published in JAMA Surgery.
“To balance oncologic outcomes and the effect on quality of life, active surveillance is recommended for patients with relatively low risk of biochemical recurrence of localized and locally advanced PCa,” study researchers explained. “Focal therapy is an alternative that provides some degree of oncologic control while largely preserving urinary and erectile function.”
Irreversible electroporation is a new energy platform that can destroy tumor cells without producing thermal heat, resulting in minimal damage to nearby healthy tissue. However, no clinical trials of H-FIRE have been done.
In this single-group, nonrandomized trial, 109 patients with low or intermediate risk of biochemical recurrence of localized and locally advanced prostate cancer underwent H-FIRE ablation of all lesions identified with biopsy.
Of these, 100 men underwent biopsy at 6 months. The 6-month clinically significant prostate cancer rate was 6.0%. According to the researchers, superiority criteria compared with the historical control of 20% was achieved. Of the case of clinically significant prostate cancer, only one was inside the treatment zone, researchers noted.
Superiority versus the historical control was also achieved in a subgroup analysis of 57 patients with Gleason score of 7 at baseline (3.5% vs historical control of 20%).
The diaper-free rate was 99.1% at baseline and 98% at 6 months. Only 9 patients (9%) experienced emergent sexual dysfunction.
“Results of this nonrandomized controlled trial showed encouraging efficacy and minimal effect on functional outcomes in patients receiving extensive focal ablation with H-FIRE for localized PCa,” the researchers wrote. “Future trials with larger sample sizes that compare H-FIRE directly with a thermal energy platform should be performed.”