一项研究高危特征前列腺癌放疗时机的 III 期临床试验：放疗——辅助与早期挽救（RAVES）试验的背景和原理。

A Phase III trial to investigate the timing of radiotherapy for prostate cancer with high-risk features: background and rationale of the Radiotherapy -- Adjuvant Versus Early Salvage (RAVES) trial.

机构信息

Department of Radiation Oncology, Auckland City Hospital, Auckland, New Zealand.

出版信息

BJU Int. 2014 Mar;113 Suppl 2:7-12. doi: 10.1111/bju.12623.

DOI:10.1111/bju.12623

PMID:24894850

Abstract

OBJECTIVES

To test the hypothesis that observation with early salvage radiotherapy (SRT) is not inferior to 'standard' treatment with adjuvant RT (ART) with respect to biochemical failure in patients with pT3 disease and/or positive surgical margins (SMs) after radical prostatectomy (RP). To compare the following secondary endpoints between the two arms: patient-reported outcomes, adverse events, biochemical failure-free survival, overall survival, disease-specific survival, time to distant failure, time to local failure, cost utility analysis, quality adjusted life years and time to androgen deprivation.

PATIENTS AND METHODS

The Radiotherapy - Adjuvant Versus Early Salvage (RAVES) trial is a phase III multicentre randomised controlled trial led by the Trans Tasman Radiation Oncology Group (TROG), in collaboration with the Urological Society of Australia and New Zealand (USANZ), and the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). In all, 470 patients are planned to be randomised 1:1 to either ART commenced at ≤4 months of RP (standard of care) or close observation with early SRT triggered by a PSA level of >0.20 ng/mL (experimental arm). Eligible patients have had a RP for adenocarcinoma of the prostate with at least one of the following risk factors: positive SMs ± extraprostatic extension ± seminal vesicle involvement. The postoperative PSA level must be ≤0.10 ng/mL. Rigorous investigator credentialing and a quality assurance programme are designed to promote consistent RT delivery among patients.

RESULTS

Trial is currently underway, with 258 patients randomised as of 31 October 2013. International collaborations have developed, including a planned meta-analysis to be undertaken with the UK Medical Research Council/National Cancer Institute of Canada Clinical Trials Group RADICALS (Radiotherapy and Androgen Deprivation In Combination with Local Surgery) trial and an innovative psycho-oncology sub-study to investigate a patient decision aid resource.

CONCLUSION

On the current evidence available, it remains unclear if ART is equivalent or superior to observation with early SRT.

摘要

目的

检验假设，即在根治性前列腺切除术后（RP）出现 pT3 疾病和/或阳性切缘（SM）的患者中，与辅助放疗（ART）的“标准”治疗相比，早期挽救放疗（SRT）观察在生化失败方面没有劣势。比较两条治疗线之间以下次要终点：患者报告的结局、不良事件、生化无失败生存、总生存、疾病特异性生存、远处失败时间、局部失败时间、成本效用分析、调整后的生命质量年和雄激素剥夺时间。

患者和方法

放疗-辅助与早期挽救（RAVES）试验是由澳大利亚和新西兰的 Trans Tasman 放射肿瘤学组（TROG）领导的一项 III 期多中心随机对照试验，与澳大利亚和新西兰泌尿生殖和前列腺癌试验组（ANZUP）和澳大利亚和新西兰泌尿生殖和前列腺癌试验组（USANZ）合作进行。共计划招募 470 名患者，1:1 随机分为 ART 组或早期 SRT 组。ART 组在 RP 后 4 个月内开始（标准治疗），SRT 组在 PSA 水平>0.20ng/ml 时开始密切观察。入组患者的前列腺腺癌至少有以下一个危险因素：SM 阳性 ± 前列腺外扩展 ± 精囊侵犯。术后 PSA 水平必须≤0.10ng/ml。严格的研究者资格认证和质量保证计划旨在促进患者接受一致的 RT 治疗。