Systemic therapy for advancing or metastatic prostate cancer (STAMPEDE): a multi-arm, multistage randomized controlled trial
Systemic therapy for advancing or metastatic prostate cancer (STAMPEDE): a multi-arm, multistage randomized controlled trial
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DOI：
10.1111/j.1464-410x.2008.08034.x
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发表时间：
2009-02-01
影响因子：
4.5
通讯作者：
Parmar, Mahesh K. B.
中科院分区：
文献类型：
--
作者：
James, Nicholas D.;Sydes, Matthew R.;Parmar, Mahesh K. B.
需要改善患有高风险局部、结节或转移性前列腺癌的男性，或者在局部疾病初始治疗后患有侵袭性复发疾病的男性的结果。这组男性目前正在接受长期激素治疗。因此，我们的目的是评估三种不同的全身疗法（多西紫杉醇、唑来膦酸和塞来昔布）在高危前列腺癌激素控制开始时单独使用或联合使用的毒性和疗效。一种新颖的统计设计（多臂、多阶段方法）同时针对单个控制臂并行测试多个不同策略。该试验有几个“阶段”，从最初的安全性确认到第三阶段的生存评估，以及一系列干预活动阶段。该方法提供了一种更快速、更有效地评估多种药物的方法，并允许在早期阶段从进一步的研究中放弃非活性治疗。 STAMPEDE 旨在同时解决这些药物对该患者群体的活性和功效。这是英国前列腺癌学术研究的旗舰随机临床试验。已按计划招募了 500 多名患者，证实了患者和临床医生可以接受这一复杂的试验设计。该试验的目标人群约为 3000 名患者。 STAMPEDE 是一项重大的新试验，其新颖的设计适用于多种药物的同步测试。希望这些结果能够改善高危前列腺癌患者的预后。该设计可适用于其他癌症类型的新疗法的研究。泌尿癌界需要继续努力，以保持迄今为止的出色招募。
There is a need to improve the outcomes for men with high-risk localised, nodal or metastatic prostate cancer, or with aggressively relapsing disease after initial therapy for local disease. This group of men is currently managed with long-term hormone therapy. Thus we aim to evaluate the toxicity and efficacy of three different systemic therapies (docetaxel, zoledronic acid and celecoxib) used alone or combined at the initiation of hormone manipulation for high-risk prostate cancer. A novel statistical design (multi-arm, multistage method) simultaneously tests multiple distinct strategies in parallel against a single control arm. The trial has several 'stages', from initial confirmation of safety to a phase III assessment of survival, with a series of intervening activity stages. This method provides a means of assessing several agents more quickly and efficiently, and allows inactive treatments to be dropped from further study at an early stage. STAMPEDE has been designed to address in parallel the activity and efficacy of these agents for this patient group. It is a flagship randomized clinical trial for academic research into prostate cancer in the UK. More than 500 patients have been recruited on schedule, confirming the acceptability of this complex trial design to patients and clinicians. The trial targets a population of approximate to 3000 patients.STAMPEDE is a major new trial with a novel design applicable to the synchronous testing of several agents. It is hoped that the results will improve outcomes for patients with high-risk prostate cancer. The design could be applicable to the study of new therapies in other cancer types. Continued efforts are required by the urological cancer community to maintain the excellent recruitment shown to date.