BACKGROUND The ProtecT trial reported intention-to-treat analysis of men with localised prostate cancer (PCa) randomly allocated to active monitoring (AM), radical prostatectomy, and external beam radiotherapy. OBJECTIVE To determine report outcomes according to treatment received in men in randomised and treatment choice cohorts. DESIGN, SETTING, AND PARTICIPANTS This study focuses on secondary care. Men with clinically localised prostate cancer at one of nine UK centres were invited to participate in the treatment trial comparing AM, radical prostatectomy, and radiotherapy. INTERVENTION Two cohorts included 1643 men who agreed to be randomised; 997 declined randomisation and chose treatment. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Health-related quality of life impacts on urinary, bowel, and sexual function were assessed using patient-reported outcome measures. Analysis was carried out based on treatment received for each cohort and on pooled estimates using meta-analysis. Differences were estimated with adjustment for known prognostic factors using propensity scores. RESULTS AND LIMITATIONS According to treatment received, more men receiving AM died of PCa (AM 1.85%, surgery 0.67%, radiotherapy 0.73%), whilst this difference remained consistent with chance in the randomised cohort (p=0.08); stronger evidence was found in the exploratory analyses (randomised plus choice cohort) when AM was compared with the combined radical treatment group (p=0.003). There was also strong evidence that metastasis (AM 5.6%, surgery 2.4%, radiotherapy 2.7%) and disease progression (AM 20.35%, surgery 5.87%, radiotherapy 6.62%) were more common in the AM group. Compared with AM, there were higher risks of sexual dysfunction (95% at 6mo) and urinary incontinence (55% at 6mo) after surgery, and of sexual dysfunction (88% at 6mo) and bowel dysfunction (5% at 6mo) after radiotherapy. The key limitations are the potential for bias when comparing groups defined by treatment received and outdating of the interventions being evaluated during the lengthy follow-up required in trials of screen-detected PCa. CONCLUSIONS Analyses according to treatment received showed increased rates of disease-related events and lower rates of patient-reported harms in men managed by AM compared with men managed by radical treatment, and stronger evidence of greater PCa mortality in the AM group. PATIENT SUMMARY More than 90 out of every 100 men with localised prostate cancer do not die of prostate cancer within 10yr, irrespective of whether treatment is by means of monitoring, surgery, or radiotherapy. Side effects on sexual and bladder function are much better after active monitoring, but the risks of spreading of prostate cancer are more common.

中文翻译：

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根据 ProtecT 随机对照试验，根据接受的治疗，患有局限性前列腺癌的男性十年死亡率、疾病进展和治疗相关副作用。


背景 ProtecT 试验报告了对随机分配至主动监测 (AM)、根治性前列腺切除术和外照射放射治疗的局限性前列腺癌 (PCa) 男性的意向治疗分析。目的 根据随机和治疗选择队列中男性接受的治疗确定报告结果。设计、设置和参与者 本研究的重点是二级护理。英国九个中心之一的患有临床局限性前列腺癌的男性被邀请参加这项比较 AM、根治性前列腺切除术和放疗的治疗试验。干预 两个队列包括 1643 名同意随机分组的男性； 997 人拒绝随机分组并选择治疗。结果测量和统计分析 使用患者报告的结果测量来评估与健康相关的生活质量对泌尿、肠道和性功能的影响。根据每个队列接受的治疗以及使用荟萃分析的汇总估计值进行分析。使用倾向评分调整已知预后因素来估计差异。结果和局限性 根据接受的治疗，更多接受 AM 的男性死于 PCa（AM 1.85%，手术 0.67%，放疗 0.73%），而这种差异与随机队列中的几率保持一致（p=0.08）；当 AM 与联合根治治疗组进行比较时，在探索性分析（随机加选择队列）中发现了更有力的证据 (p=0.003)。还有强有力的证据表明，转移（AM 5.6%，手术 2.4%，放疗 2.7%）和疾病进展（AM 20.35%，手术 5.87%，放疗 6.62%）在 AM 组中更为常见。 与AM相比，术后发生性功能障碍（6mo时为95%）和尿失禁（6mo时为55%）的风险较高，放疗后发生性功能障碍（6mo时为88%）和肠功能障碍（6mo时为5%）的风险较高。关键的局限性在于，在对根据接受的治疗定义的组进行比较时，以及在筛查检测 PCa 试验所需的长期随访期间评估的干预措施是否过时时，可能会出现偏倚。结论 根据接受的治疗进行的分析显示，与接受根治性治疗的男性相比，接受 AM 治疗的男性中疾病相关事件发生率更高，患者报告的伤害率更低，更有力的证据表明 AM 组 PCa 死亡率更高。患者摘要 每 100 名患有局限性前列腺癌的男性中，超过 90 名男性不会在 10 年内死于前列腺癌，无论治疗是通过监测、手术还是放射治疗。积极监测后，对性和膀胱功能的副作用要好得多，但前列腺癌扩散的风险更常见。