Objective:To explore the efficient prognostic factors of cryotherapy for prostate cancer in the real-world setting.Methods:The clinical data of 105 prostate cancer patients treated at the Fudan University Shanghai Cancer center from January 2021 to December 2023 were analyzed retrospectively. The patients were divided into a non-metastatic group (62 cases, 58.7%) and a metastatic group (43 cases, 41.3%) based on the presence or absence of distant metastasis. In the non-metastatic group, the median age was 79 years (range 73 to 82), the initial PSA was 20 ng/ml (range 10 to 47), 37 cases (59.7%) received neoadjuvant endocrine therapy, and the preoperative PSA was 8 ng/ml (range 2 to 14). The ISUP grades were Grade 1 in 4 cases (6.5%), Grade 2 in 11 cases (17.7%), Grade 3 in 16 cases (25.8%), Grade 4 in 16 cases (25.8%), and Grade 5 in 15 cases (24.2%). The T-stages were T 2 in 49 cases, T 3 in 6 cases, and T 4 in 7 cases. All cases were N 0. In the metastatic group, the median age was 68 years (range 62 to 74), the initial PSA was 64 ng/ml (range 27 to 200), 42 cases (97.7%) received neoadjuvant endocrine therapy, and the preoperative PSA was 0 ng/ml (range 0 to 3). The ISUP grades were Grade 1 in 0 cases, Grade 2 in 5 cases (11.6%), Grade 3 in 3 cases (7.0%), Grade 4 in 19 cases (44.2%), and Grade 5 in 16 cases (37.2%). The T-stages were T 2 in 29 cases (67.4%), T 3 in 8 cases (18.6%), and T 4 in 6 cases (14.0%). The N-stages were N 0 in 38 cases (88.4%) and N 1 in 5 cases (11.6%). The M-stages were M 1a in 5 cases (11.6%), M 1b in 35 cases (81.4%), and M 1c in 3 cases (7.0%). The difference in T-stage between the two groups was not statistically significant ( P=0.346), while differences in other indicators were statistically significant ( P<0.05). The cryotherapy for prostate cancer was performed under general or local anesthesia, with the patients in the lithotomy position and a F20 three-lumen catheter was placed for continuous irrigation. Under transrectal ultrasound guidance, the cryoprobes were inserted parallel to the probe through the perineum, with a safe distance of 3 mm from the bladder wall. A whole-gland freezing mode was adopted, starting from the ventral side and freezing layer by layer towards the rectal side. Ultrasound was used in real-time to observe the ice ball's position and extent, adjusting it during ablation to conform to the prostate's margins while protecting surrounding structures. After ablation, the cryoprobes were removed, the puncture sites were disinfected with povidone-iodine, and gauze was applied for 20 seconds to achieve hemostasis before applying dressings. The catheter was removed 10 days postoperatively. PSA levels were rechecked on the first postoperative day and at 6 and 12 weeks postoperatively. The ratio of PSA on the first postoperative day to preoperative PSA was defined as the PSA release rate. Biochemical recurrence was defined as a PSA increase of more than 0.2 ng/ml above the postoperative nadir. The PSA progression-free survival time and the incidence of complications were compared between the two groups. Results:All procedures were successfully completed. The PSA release rates for the non-metastatic and metastatic groups were 4.2 (2.2, 6.4) and 3.9 (1.5, 6.7), respectively, with no statistical significant difference ( P=0.8272). The median PSA at 6 weeks postoperatively was 0.23 (0.01, 1.22) ng/ml, and at 12 weeks it was 0.02 (0.01, 0.49) ng/ml. The median PSA for the non-metastatic group was 0.42 (0.25, 1.00) ng/ml at 6 weeks, and it was 0.03 (0.01, 0.57) ng/ml at 12 weeks. For the metastatic group, the median PSA was 0.30 (0.14, 0.50) ng/ml at 6 weeks, and it was 0.02 (0.01, 1.17) ng/ml at 12 weeks. The median follow-up period was 339 days (range 128 to 571). No Clavien-Dindo grade ≥2 complications occurred postoperatively. One case (0.9%) experienced bladder neck stricture one month postoperatively, which improved by transurethral resection of the prostate (TURP). Two cases (1.9%) experienced urinary retention seven days postoperatively, which resolved after re-catheterization for two weeks. No urinary incontinence was reported. Two non-tumor-related deaths occurred (1.9%), one due to cardiac disease and the other due to complications from COVID-19. During follow-up, 29 cases (27.6%) experienced PSA progression, with a median PSA progression-free survival time of 808.0 days. The median PSA progression-free survival time was not reached in the non-metastatic group, while it was 764.0 days in the metastatic group. There was no statistical significant difference in PSA progression-free survival between the two groups ( P=0.422). Univariate analysis showed that preoperative PSA ( HR=1.02, 95% CI 1.00-1.03, P=0.048), T 3 stage ( HR=9.00, 95% CI 2.59-31.25, P<0.01), and T 4 stage ( HR=5.83, 95% CI 1.68-20.21, P=0.005) were prognostic factors for PSA progression-free survival. Multivariate analysis showed that T 3 stage ( HR=9.08, 95% CI 2.47-33.45, P<0.01) and T 4 stage ( HR=4.50, 95% CI 1.18-17.22, P=0.028) were independent prognostic factors for PSA progression-free survival. Conclusions:Cryotherapy for prostate cancer has a high safety profile. The efficacy of Cryotherapy is better in patients with T-stage