Focal Cryotherapy in Prostate Cancer. Does Gleason Impact Results?

ABSTRACT Purpose: Focal cryotherapy is a minimally invasive treatment for localized prostate cancer (PCa), but its oncological outcomes, particularly in relation to baseline Gleason Grade Group (GG), remain understudied. This study evaluates its efficacy and the impact while radical of baseline Gleason score on recurrence-free survival. Materials and Methods: A retrospective analysis included 111 patients with localized PCa treated with focal cryotherapy between 2014 and January 2024. Patients with prior treatments or follow-up <12 months were excluded. All patients underwent MRI and transperineal biopsy, and cryotherapy was performed using the Visual ICE Cryoablation System. Confirmatory biopsies were recommended at 12–24 months post-treatment. Recurrence was classified as either in-field (treated or adjacent areas) or out-field (non-adjacent areas). Any recurrence-free survival was defined as the absence of positive biopsy or additional treatment. Radical treatment-free survival was defined as the absence of whole-gland treatment (e.g., radical prostatectomy, radiotherapy), androgen deprivation therapy, metastasis, or death. Outcomes were compared between patients with baseline GG 1 and GG >1. Results: Median follow-up was 35 months (IQR 24–49). Confirmatory biopsies were performed in 78% of patients (n=87), revealing in-field recurrence in 10% and out-field recurrence in 23%. There were no statistically significant differences between ISUP 1 and ISUP >1 groups in terms of protocol biopsy positivity for either in-field recurrence (HR 0.41; 95% CI 0.09–1.9) or out-field recurrence (HR 0.77; 95% CI 0.3–1.98). At three-years, the rates of any recurrence-free and radical treatment-free survival were 63% and 85%, respectively, with no significant variation by baseline GG. Conclusion: Focal cryotherapy provides favorable short-term oncological outcomes in localized PCa, with no significant differences in recurrence-free survival based on baseline Gleason score.