Purpose: Statin use is reportedly associated with the risk of prostate cancer, outcomes after treatment, and prostate cancer-specific mortality. We sought to determine the efficacy of adjuvant atorvastatin in prostate cancer after radical prostatectomy. Patients and Methods: In this randomized, double-blind trial, we assigned patients with pathologic high-risk prostate cancer to receive either low-dose atorvastatin (20 mg/day, n = 183) or placebo ( n = 181) for 1 year after radical prostatectomy. The primary endpoint was the 1-year biochemical recurrence rate. The secondary endpoints included the 5-year biochemical recurrence-free survival and changes in lipid, testosterone, and sex hormone binding globulin levels. Results: From October 2012 through January 2019, a total of 364 patients underwent randomization. Among 59 total primary end points, 30 (16.4%) and 29 (16.0%) occurred in the atorvastatin and placebo groups, respectively. Atorvastatin did not significantly reduce the primary endpoint of 1-year biochemical recurrence [HR, 0.96; 95% confidence interval (CI), 0.58–1.60]. During a median follow-up of 24 months, 131 patients experienced biochemical recurrence (68 in the atorvastatin group and 63 in the placebo group), representing Kaplan–Meier estimated event rates of 24.0% and 25.4% in the atorvastatin and placebo groups, respectively, at 24 months (HR, 1.00; 95% CI, 0.71–1.41). We observed no significant between-group differences in the testosterone and sex hormone binding globulin levels. Conclusions: Among patients with high-risk pathologic features after radical prostatectomy for prostate cancer, 1-year adjuvant use of atorvastatin was not associated with a lower risk of disease recurrence compared with that for placebo. (ClinicalTrials.gov number, [NCT01759836][1]). See related commentary by Murtola and Siltari, [p. 4947][2] [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01759836&atom=%2Fclincanres%2F27%2F18%2F5004.atom [2]: /lookup/volpage/27/4947?iss=18

中文翻译：

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根治性前列腺切除术后辅助使用低剂量他汀类药物：PRO-STAT 随机临床试验

目的：据报道，他汀类药物的使用与前列腺癌的风险、治疗后的结果和前列腺癌特异性死亡率有关。我们试图确定在根治性前列腺切除术后辅助阿托伐他汀对前列腺癌的疗效。患者和方法：在这项随机、双盲试验中，我们将病理性高危前列腺癌患者分配接受低剂量阿托伐他汀（20 mg/天，n = 183）或安慰剂（n = 181）治疗 1 年根治性前列腺切除术后。主要终点是1年生化复发率。次要终点包括 5 年无生化复发生存率以及血脂、睾酮和性激素结合球蛋白水平的变化。结果：从 2012 年 10 月到 2019 年 1 月，共有 364 名患者接受了随机分组。在总共 59 个主要终点中，阿托伐他汀组和安慰剂组分别发生 30 例（16.4%）和 29 例（16.0%）。阿托伐他汀并未显着降低 1 年生化复发的主要终点 [HR，0.96；95% 置信区间 (CI), 0.58–1.60]。在 24 个月的中位随访期间，131 名患者出现生化复发（阿托伐他汀组 68 人，安慰剂组 63 人），代表 Kaplan-Meier 估计阿托伐他汀组和安慰剂组的事件发生率分别为 24.0% 和 25.4% ，在 24 个月时（HR，1.00；95% CI，0.71–1.41）。我们观察到睾酮和性激素结合球蛋白水平没有显着的组间差异。结论：在前列腺癌根治性前列腺切除术后具有高危病理特征的患者中，与安慰剂相比，阿托伐他汀辅助使用 1 年与疾病复发风险降低无关。（ClinicalTrials.gov 编号，[NCT01759836][1]）。见 Murtola 和 Siltari 的相关评论，[p. 4947][2] [1]：/lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01759836&atom=%2Fclincanres%2F27%2F18%2F5004.atom [2]：/lookup/volpage/27/4947?iss=18