van As Nicholas, Yasar Binnaz, Griffin Clare, Patel Jaymini, Tree Alison C, Ostler Peter, van der Voet Hans, Ford Daniel, Tolan Shaun, Wells Paula, Mahmood Rana, Winkler Mathias, Chan Andrew, Thompson Alan, Ogden Chris, Naismith Olivia, Pugh Julia, Manning Georgina, Brown Stephanie, Burnett Stephanie, Hall Emma
The Royal Marsden Hospital, London, UK; The Institute of Cancer Research, London, UK.
The Royal Marsden Hospital, London, UK; The Institute of Cancer Research, London, UK.
Eur Urol. 2024 Dec;86(6):566-576. doi: 10.1016/j.eururo.2024.08.030. Epub 2024 Sep 11.
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.
缺乏关于局部前列腺癌立体定向体部放疗（SBRT）和前列腺切除术患者报告结局（PRO）的随机数据。PACE-A比较了SBRT与前列腺切除术后患者报告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将低至中危局部前列腺癌男性随机分为SBRT组或前列腺切除术组（1:1）。不允许进行雄激素剥夺治疗（ADT）。共同主要结局为2年时每日所需吸收性尿垫数量的扩展前列腺指数综合评分（EPIC-26）和肠道领域评分。次要终点为临床医生报告的毒性、性功能和其他PRO。
2012年8月至2022年2月，共有123名男性被随机分组（60例行前列腺切除术，63例行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%患有美国国立综合癌症网络（NCCN）中危疾病。50名参与者接受了前列腺切除术，60名接受了SBRT。2年时，16/32（50%）接受前列腺切除术的参与者和46名接受SBRT的参与者中的3名（6.5%）每天使用一个或多个尿垫（p<0.001；分别有15名和2名每天使用一个尿垫）；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[四分位间距]100[100-100]）优于SBRT（87.5[79.2-100]；p<0.001），两者之间的估计平均差异为8.9（95%CI：4.2，13.7）；前列腺切除术的性功能评分（18[13.8-40.3]）低于SBRT（62.5[32.0-87.5]）。局限性在于招募缓慢和2年PRO应答率不完整。
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，肠道不适略多。这些随机数据应为局部中危前列腺癌患者的治疗决策提供参考。
