缺乏关于局部前列腺癌立体定向放射治疗 (SBRT) 和前列腺切除术的患者报告结果 (PRO) 的随机数据。 PACE-A 比较了患者报告的 SBRT 后与前列腺切除术后的健康相关生活质量。PACE 是一项 3 期开放标签、随机对照试验。 PACE-A 将患有低至中危局限性前列腺癌的男性随机分为 SBRT 或前列腺切除术 (1:1)。不允许雄激素剥夺疗法（ADT）。共同主要结果是每日所需的吸收性尿垫的扩展前列腺指数综合指数 (EPIC-26) 数量和 2 年时的肠道评分。次要终点是临床医生报告的毒性、性功能和其他 PRO。从 2012 年 8 月到 2022 年 2 月，共有 123 名男性被随机分配（60 名接受前列腺切除术，63 名接受 SBRT）。中位随访时间为 60.7 个月。中位年龄为 65.5 岁，中位前列腺特异性抗原 (PSA) 值为 7.9 ng/ml； 92% 患有国家综合癌症网络 (NCCN) 中危疾病。 50 名参与者接受了前列腺切除术，60 名参与者接受了 SBRT。第 2 年，16/32 (50%) 例前列腺切除术和 46 名 SBRT 参与者中的 3 名 (6.5%) 每天使用一个或多个尿垫（p < 0.001；分别有 15 人和 2 人每天使用 1 个尿垫）；估计差异为 43%（95% 置信区间 [CI]：25%、62%）。 2 年时，前列腺切除术的肠道评分（中位数[四分位数范围] 100 [100-100]）优于 SBRT（87.5 [79.2-100]；p < 0.001），估计两者之间的平均差异为 8.9 (95 % CI: 4.2, 13.7);前列腺切除术的性评分 (18 [13.8-40.3]) 比 SBRT (62.5 [32.0-87.5]) 更差。其局限性在于招募缓慢和 2 年 PRO 反应率不完整。与前列腺切除术相比，SBRT 与患者报告的尿失禁和性功能障碍较少相关，并且肠道问题略多。这些随机数据应该为局部中危前列腺癌患者的治疗决策提供信息。版权所有 © 2024 作者。由 Elsevier B.V. 出版。保留所有权利。

Randomised data on patient-reported outcomes (PROs) for stereotactic body radiotherapy (SBRT) and prostatectomy in localised prostate cancer are lacking. PACE-A compared patient-reported health-related quality of life after SBRT with that after prostatectomy.PACE is a phase 3 open-label, randomised controlled trial. PACE-A randomised men with low- to intermediate-risk localised prostate cancer to SBRT or prostatectomy (1:1). Androgen deprivation therapy (ADT) was not permitted. The coprimary outcomes were the Expanded Prostate Index Composite (EPIC-26) number of absorbent urinary pads required daily and bowel domain score at 2 yr. The secondary endpoints were clinician-reported toxicity, sexual functioning, and other PROs.In total, 123 men were randomised (60 undergoing prostatectomy and 63 SBRT) from August 2012 to February 2022. The median follow-up time was 60.7 mo. The median age was 65.5 yr and the median prostate-specific antigen (PSA) value 7.9 ng/ml; 92% had National Comprehensive Cancer Network (NCCN) intermediate-risk disease. Fifty participants received prostatectomy and 60 received SBRT. At 2 yr, 16/32 (50%) prostatectomy and three of 46 (6.5%) SBRT participants used one or more urinary pads daily (p < 0.001; 15 and two, respectively, used one pad daily); the estimated difference was 43% (95% confidence interval [CI]: 25%, 62%). At 2 yr, bowel scores were better for prostatectomy (median [interquartile range] 100 [100-100]) than for SBRT (87.5 [79.2-100]; p < 0.001), with an estimated mean difference of 8.9 between these (95% CI: 4.2, 13.7); sexual scores were worse for prostatectomy (18 [13.8-40.3]) than for SBRT (62.5 [32.0-87.5]). The limitations were slow recruitment and incomplete 2-yr PRO response rates.SBRT was associated with less patient-reported urinary incontinence and sexual dysfunction, and slightly more bowel bother than prostatectomy. These randomised data should inform treatment decision-making for patients with localised, intermediate-risk prostate cancer.Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.