To assess the impact of prostate volume on prostate-specific antigen (PSA) outcomes after primary whole-gland cryoablation.

The prognostic value of prostate volume, PSA at diagnosis, Gleason score, risk category, and clinical stage for favorable initial postcryoablation PSA (<0.6 ng/mL) was assessed in a risk-stratified cohort from the Cryo On Line Data (COLD) Registry. The cohort was substratified by prostate volume, <50 cm³ (n = 2316) and ≥50 cm³ (n = 369). The incidence of incontinence, rectal fistula, and potency is reported.

Prostate volume was not a statistically significant predictor of favorable PSA outcome (P = .153, univariate, 0.101, multivariate). Favorable PSA (<0.6 ng/mL) occurred in 80% (<50 cm³) and 83% (≥50 cm³) of patients, respectively. PSA at diagnosis (P = .02) and Gleason score (P < .0001) by univariate analysis, and clinical stage (P < .0001) and risk category (P < .0001) by multivariate analysis predicted for favorable PSA outcomes. Initial postcryoablation PSA ≥0.6 ng/mL was associated with significantly worse 24-month biochemical progression. No statistical difference in incidence of incontinence (3.3% vs 2.1%) retention (1.1% vs 2.6%), potency (30.3% vs 32.2%) or fistula (0.6% vs 0.2%) based on prostate volume was identified.

Prostate volume does not predict for favorable PSA after cryoablation. PSA at diagnosis (P = .02) and Gleason score (P < .0001) (univariate) and risk category (P < .0001) and clinical stage (P < 0.0001) (multivariate) are prognostic for favorable PSA outcomes. Morbidity was similar between groups.