Focal cryotherapy, initially utilized for low-risk prostate cancer (PCa) as an alternative to active surveillance, has expanded its applications due to advancements in imaging and biopsy techniques, including ultrasound-guided tumor localization. These improvements have enabled its use in intermediate-risk and selected high-risk localized PCa cases. This study reports the oncological and functional outcomes of focal cryotherapy from the International Focal Therapy Society (FTS) registry, a prospective, multicenter initiative.
A retrospective analysis included 282 patients who underwent ultrasound-guided focal cryoablation for localized PCa across eight centers (seven in the US and one in South America) between 2005 and 2023. The median follow-up period was 24 months, with a median age of 72 years and preoperative PSA levels of 6.8 ng/ml. Most patients had D’Amico intermediate-risk (77%) or high-risk disease (16%). Primary outcomes assessed failure-free survival (FFS), defined as avoiding salvage treatments such as radical prostatectomy, radiation therapy, repeat ablation, systemic therapy, or metastasis. Secondary outcomes evaluated cancer-specific survival (CSS), overall survival (OS), metastasis-free survival (MFS), urinary continence, and erectile function.
At five years, FFS was 74%, with MFS, CSS, and OS rates at 97%, 99%, and 96%, respectively. Post-ablation biopsies performed in 70% of patients revealed in-field and out-field recurrence rates of 11% and 18%. Functional outcomes were promising: 98% of patients maintained urinary continence without pad usage, and 74% of initially potent patients reported erections sufficient for intercourse after one year. These findings demonstrate that ultrasound-guided focal cryotherapy offers effective oncological control and preserves functional outcomes, though larger multicenter studies are needed for further validation.