Division of Urology, Department of Surgery, London Health Sciences Centre, University of Western Ontario, London, Ontario, Canada.
J Urol. 2012 Oct;188(4):1170-5. doi: 10.1016/j.juro.2012.06.014. Epub 2012 Aug 15.
We assessed and compared the survival outcomes between cryoablation and external beam radiation therapy in patients with locally advanced prostate cancer (cT2c-cT3b).
Patients with locally advanced prostate cancer, recruited from 1999 to 2002, were randomized to primary cryoablation or external beam radiotherapy. All patients received neoadjuvant hormonal therapy for 3 months before and 3 months after the procedures. Patients underwent followup transrectal ultrasound guided biopsy (at 3, 6, 12, 18 and 24 months for cryoablation, and at 18 and 24 months for external beam radiotherapy) and as clinically indicated thereafter. Biochemical failure was based on the Phoenix criterion (prostate specific antigen nadir +2 ng/dl).
A total of 62 patients completed the trial. Median followup was 105.2 months (SD ±35.8). Accrual was limited due to newer data favoring longer neoadjuvant hormonal therapy and higher external beam radiotherapy dose for locally advanced prostate cancer. There was a greater reduction in prostate volume in the cryoablation group after intervention (-54% vs -34%, p ≤0.01). Disease specific survival and overall survival were comparable between the groups. However, the 8-year biochemical disease-free survival rate was significantly lower in the cryoablation group (17.4% vs 59.1%) (p = 0.01).
This randomized trial with median followup approaching 9 years showed that cryoablation was inferior in attaining biochemical disease-free survival in patients with locally advanced prostate cancer (cT2c-T3). Cryoablation may be more suited for less bulky prostate cancer. Longer duration neoadjuvant hormonal therapy or a multimodal approach may provide optimal biochemical disease-free survival in this patient population.
我们评估并比较了局部晚期前列腺癌（cT2c-cT3b）患者中冷冻消融与外束放射治疗的生存结果。
1999 年至 2002 年期间招募了局部晚期前列腺癌患者，将其随机分配至原发性冷冻消融或外束放射治疗组。所有患者在治疗前和治疗后 3 个月内接受新辅助激素治疗。患者接受了随访经直肠超声引导活检（冷冻消融组在 3、6、12、18 和 24 个月，外束放射治疗组在 18 和 24 个月进行），并在临床需要时进行后续活检。生化失败基于凤凰标准（前列腺特异性抗原最低值+2ng/dl）。
共有 62 名患者完成了试验。中位随访时间为 105.2 个月（标准差±35.8）。由于新的数据支持对局部晚期前列腺癌患者进行更长时间的新辅助激素治疗和更高剂量的外束放射治疗，因此入组人数有限。冷冻消融组干预后前列腺体积的减少更为显著（-54%对-34%，p≤0.01）。两组间疾病特异性生存率和总生存率相当。然而，冷冻消融组 8 年生化无病生存率显著较低（17.4%对 59.1%）（p=0.01）。
这项中位随访接近 9 年的随机试验表明，冷冻消融在实现局部晚期前列腺癌（cT2c-T3）患者的生化无病生存率方面效果较差。冷冻消融可能更适合体积较小的前列腺癌。延长新辅助激素治疗时间或采用多模态治疗方法可能为该患者人群提供最佳的生化无病生存率。
