Introduction: To assess outcomes of focal Cryoablation (CRYO) and focal High Intensity Focused Ultrasound (HIFU) for Intermediate to high-risk prostate cancer (PCa). Methods: Consecutive patients who underwent hemi-gland CRYO (h-CRYO) or hemi-gland HIFU (h-HIFU) as primary treatment for D’Amico intermediate risk and high-risk PCa were identified (IRB# HS-17-00749). Patients were followed by prostate biopsy (PBx) 6-12mo and every 2yr thereafter. The primary endpoint was treatment failure (TF) defined as Grade Group (GG) =2 on follow-up (FU) PBx, any whole-gland treatment, systemic therapy, metastases, or PCa-specific mortality. Secondary endpoints included survival-free from i) biochemical failure (BF, PSA nadir + 2ng/mL); ii) GG=2 on FU-PBx, and iii) radical treatment. Kaplan-Meier and Cox regression analyses were performed for survival evaluation. International Prostate Symptom Score (IPSS), and International Index of Erectile Function (IIEF-5) were evaluated. Statistically significant if p<0.05. Results: A total of 294 patients met the inclusion criteria: 192 (65%) CRYO and 102 (35%) HIFU. The baseline characteristics were comparable between h-CRYO vs h-HIFU, as follows: median age (68 vs 66yr, p =0.2), PSA (6.6 vs 6.1ng/mL, p = 0.08), PSA density (PSAD, 0.17 vs 0.16 ng/mL2, p = 0.6), respectively. The distribution of GG for h-CRYO vs h-HIFU were as follows: GG1 (7.3% vs 2.0%), GG2-3 (77% vs 93%), and GG4-5 (15% vs 5.0%) (p < 0.004), respectively. The median FU was longer for h-CRYO (46mo) vs h-HIFU (22mo); p<0.001. The 3-year TF-free survival was: 86% for h-CRYO and 62% for h-HIFU, p=0.003. PSAD per 0.01 was an independent predictor of TF on multivariate Cox regression analysis (hazard ratio [HR] 1.02, 95% confidence interval [95%CI] 1.01-1.03), but h-HIFU vs h-CRYO was not (HR 1.27, 95%CI 0.69-2.33). The 3-year free survival were, for h-CRYO vs h-HIFU: BF (75% vs 81%, p=0.76); GG=2 on FU-PBx (88% vs 62%, p<0.001), and radical treatment (97% vs 83%, p=0.1), respectively. PSAD per 0.01 and the number of cancer cores on baseline PBx were independent predictors of GG=2 on FU-PBx, but h-HIFU vs h-CRYO was not (HR 1.34, 95%CI 0.72-2.48). The median difference from pre- to post-FT IPSS (0 vs 1; p=0.27) was similar for h-CRYO vs h-HIFU, respectively. The median IIEF-5 decreased more after CRYO than HIFU (2 vs 0; p=0.005). Continence (zero pad) was maintained in 97% for h-CRYO and in 97% for h-HIFU (p=1.00). Conclusions: Hemi-gland CRYO and HIFU provide comparable and acceptable medium-term oncologic outcomes for intermediate-high risk PCa, with excellent functional outcomes. SOURCE OF Funding: None.
