Lepor Herbert, Rapoport Eli, Tafa Majlinda, Gogaj Rozalba, Wysock James S
Department of Urology, NYU Grossman School of Medicine, New York, NY.
Urology. 2025 Feb;196:189-195. doi: 10.1016/j.urology.2024.10.039. Epub 2024 Oct 22.
To assess 5-year oncologic outcomes following primary partial gland cryo-ablation (PPGCA) in intermediate-risk prostate cancer.
Of 476 men undergoing PPGCA enrolled in our prospective oncologic and functional outcomes study, 313 had magnetic resonance imaging (MRI) concordant intermediate-risk prostate cancer with no out-of-field Gleason grade group ≥2, gross extracapsular extension, or extreme apical disease on pre-treatment multi-parametric MRI. Prostatic-specific antigen was monitored every 6 months, and multi-parametric MRI at 6 to 12, 24, 42, and 60 months. Protocol biopsies at 6-12 months and 24 months were discontinued after interim analysis showing low rates of clinically significant prostate cancer (csPCa) defined as any Gleason grade group ≥2 disease. Freedom-from-failure was defined as no prostate cancer-specific mortality, metastatic disease, or whole-gland salvage treatment.
csPCa was detected in 33 (10.5%) subjects. Ninety-one had ≥4.5 years of follow-up data with a mean of 8.9, 3.4, and 2.0 surveillance prostatic-specific antigen tests, MRIs, and prostate biopsies; none were lost to follow-up. At 5 years, rates of freedom-from-recurrence of in-field, out-of-field, and overall csPCa were 86% (95% confidence interval [CI]: 78-96), 85% (95% CI: 63-94), and 70% (95% CI: 57-84). The proportion with freedom-from-failure at 5 years was 89% (95% CI: 83-95). None died from prostate cancer, 1 (1%) developed metastasis, 15 (16.5%) underwent whole-gland salvage treatment, and 15 (16.5%) underwent salvage focal therapy. Only 3 of 91 (3.3%) eligible men were non-compliant with 5-year surveillance protocol.
Very encouraging intermediate-term oncological outcomes following PPGCA were observed with very high compliance to a rigorous prospective protocol for identifying recurrent csPCa.
评估中度风险前列腺癌患者接受原发性部分腺体冷冻消融术（PPGCA）后的5年肿瘤学结局。
在我们开展的一项关于肿瘤学和功能结局的前瞻性研究中，476例接受PPGCA的男性患者中，313例患者的磁共振成像（MRI）显示为中度风险前列腺癌，且治疗前多参数MRI检查未发现 Gleason 分级组≥2的非靶区病变、包膜外侵犯或尖部病变。每6个月监测一次前列腺特异性抗原，并在6至12个月、24个月、42个月和60个月时进行多参数MRI检查。中期分析显示临床显著前列腺癌（csPCa，定义为任何Gleason分级组≥2的疾病）发生率较低后，停止了6至12个月和24个月时的方案规定活检。无失败生存期定义为无前列腺癌特异性死亡、转移或全腺体挽救治疗。
33例（10.5%）受试者检测到csPCa。91例患者有≥4.5年的随访数据，平均进行了8.9次、3.4次和2.0次前列腺特异性抗原监测、MRI检查和前列腺活检；均无失访。5年时，靶区内、靶区外和总体csPCa的无复发生存率分别为86%（95%置信区间[CI]：78-96）、85%（95%CI：63-94）和70%（95%CI：57-84）。5年时无失败生存的比例为89%（95%CI：83-95）。无患者死于前列腺癌，1例（1%）发生转移，15例（16.5%）接受了全腺体挽救治疗，15例（16.5%）接受了挽救性局部治疗。91例符合条件的男性中只有3例（3.3%）未遵守5年监测方案。
PPGCA术后观察到非常令人鼓舞的中期肿瘤学结局，对用于识别复发性csPCa的严格前瞻性方案的依从性非常高。
