Primary Whole-gland Cryoablation for Prostate Cancer: Biochemical Failure and Clinical Recurrence at 5.6 Years of Follow-up.

We retrospectively evaluated complications and functional and oncologic outcomes of 94 consecutive men who underwent primary whole-gland cryoablation for localized prostate cancer (PCa) from 2002 to 2012. Kaplan-Meier and multivariable Cox regression analyses were performed using a landmark starting at 6 mo of follow-up. In total, 75% patients had D'Amico intermediate- (48%) or high- (27%) risk PCa. Median follow-up was 5.6 yr. Median time to prostate-specific antigen (PSA) nadir was 3.3 mo, and 70 patients reached PSA <0.2ng/ml postcryoablation. The 90-d high-grade (Clavien Grade IIIa) complication rate was 3%, with no rectal fistulas reported. Continence and potency rates were 96% and 11%, respectively. The 5-yr biochemical failure-free survival (PSA nadir+2ng/ml) was 81% overall and 89% for low-, 78% for intermediate-, and 80% for high-risk PCa (p=0.46). The median follow-up was 5.6 and 5.1 yr for patients without biochemical failure and with biochemical failure, respectively. The 5-yr clinical recurrence-free survival was 83% overall and 94% for low-, 84% for intermediate-, and 69% for high-risk PCa (p=0.046). Failure to reach PSA nadir <0.2ng/ml within 6 mo postcryoablation was an independent predictor for biochemical failure (p=0.006) and clinical recurrence (p=0.03). The 5-yr metastases-free survival was 95%. Main limitation is retrospective evaluation. Primary whole-gland cryoablation for PCa provides acceptable medium-term oncologic outcomes and could be an alternative for radiation therapy or radical prostatectomy. PATIENT SUMMARY: Cryoablation is a safe, minimally-invasive procedure that uses cold temperatures delivered via probes through the skin to kill prostate cancer (PCa) cells. Whole-gland cryoablation may offer an alternative treatment option to surgery and radiotherapy. We found that patients had good cancer outcomes 5 yr after whole-gland cryoablation, and those with a prostate-specific antigen value ≥0.2ng/ml within 6 mo after treatment were more likely to have PCa recurrence.