Abstract

Introduction

Prostate cryotherapy is an available treatment option for localized prostate cancer (PC) included on minimal invasive therapies but still under evaluation. We started our cryotherapy program in 2008 for selected patients with localized PC. Our objective is to evaluate the oncologic and functional outcomes of primary cryotherapy in men with clinically localized PC.

Subjects and Methods

We retrospectively evaluated all patients who underwent primary cryotherapy for localized PC treatment at our center between January 2008 and December 2017. In order to downsize prostates between 40 and 60cc neoadjuvant 3-month hormonal therapy was administered. Primary endpoint was biochemical progression-free survival (BPFS) rate as defined by the Phoenix criteria. Secondary endpoints were cancer-specific survival (CSS), overall survival (OS), patient reported functional outcomes and complication rates. Factors influencing de BPFS were evaluated individually using Kaplan–Meyer and Cox regression models and in a multivariate model using Cox regression.

Results

During the mentioned period, a total of 177 men were treated with cryotherapy. With a mean follow-up of 60 months (SD 32.9), the Kaplan–Meier analysis shows an overall BPFS rate was 67%. BPFS by risk group was 70.2%, 70.3% and 50.0% for the low, intermediate and high risk groups, respectively (p = 0.925). Overall time to BR was 93.67 months (SD 2.84, IC95%: 88.10–99.24): 95.91 (SD 3,44), 93.23 (SD 4.81) and 89.77 (SD 6.67) months for the low, intermediate and high risk groups, respectively. In both univariate and multivariate analysis, the only predictor of biochemical progression was de PSA nadir (HR 1.56 IC95%: 1.50–1.63). Continence was fully maintained in 95% of patients after the procedure. Postoperative complications included UTI (17.5%), hematuria (9.6%), perineal hematoma (11%) and postoperative pain (4.5%). No fistulas were reported. 8.5% of patients had acute urinary retention solved conservatively.

Conclusion

Cryotherapy is a safe option for selected patients with localized prostate cancer that provides competitive oncologic outcomes and a low morbidity profile.

中文翻译：

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用于局部前列腺癌治疗的初级冷冻疗法

摘要

介绍

前列腺冷冻疗法是局部前列腺癌 (PC) 的一种可用治疗选择，包括在微创疗法中，但仍在评估中。我们于 2008 年开始为选定的局部 PC 患者开展冷冻治疗计划。我们的目标是评估初级冷冻疗法对临床局限性 PC 患者的肿瘤学和功能结果。

主题和方法

我们回顾性评估了 2008 年 1 月至 2017 年 12 月期间在我们中心接受初级冷冻治疗以进行局部 PC 治疗的所有患者。为了缩小 40 至 60cc 的前列腺体积，进行了 3 个月的新辅助激素治疗。主要终点是由 Phoenix 标准定义的生化无进展生存 (BPFS) 率。次要终点是癌症特异性生存期（CSS）、总生存期（OS）、患者报告的功能结果和并发症发生率。使用 Kaplan-Meyer 和 Cox 回归模型以及使用 Cox 回归的多变量模型单独评估影响 de BPFS 的因素。

结果

在上述期间，共有 177 名男性接受了冷冻疗法。Kaplan-Meier 分析显示平均随访 60 个月（标准差 32.9），总体 BPFS 率为 67%。低、中、高风险组的 BPFS 分别为 70.2%、70.3% 和 50.0%（p = 0.925)。低、中、高风险组的 BR 总时间分别为 93.67 个月（SD 2.84，IC95%：88.10–99.24）：95.91（SD 3.44）、93.23（SD 4.81）和 89.77（SD 6.67）个月. 在单变量和多变量分析中，生化进展的唯一预测因子​​是 de PSA 最低点 (HR 1.56 IC95%: 1.50–1.63)。95% 的患者在手术后完全保持了节制。术后并发症包括尿路感染（17.5%）、血尿（9.6%）、会阴血肿（11%）和术后疼痛（4.5%）。未报告瘘管。8.5%的患者急性尿潴留保守治疗。

结论

对于局部前列腺癌患者，冷冻疗法是一种安全的选择，可提供具有竞争力的肿瘤学结果和低发病率。