MRC Clinical Trials Unit at University College London, London, UK.
MRC Clinical Trials Unit at University College London, London, UK.
Eur Urol Focus. 2019 Mar;5(2):137-143. doi: 10.1016/j.euf.2019.01.005. Epub 2019 Feb 1.
There are many ongoing randomised trials of promising therapies for metastatic hormone-sensitive prostate cancer (mHSPC), but standard systematic reviews may not synthesise these in a timely or reliable way. We demonstrate how a novel approach to evidence synthesis is being used to speed up and improve treatment evaluations for mHSPC. This more prospective, dynamic, and collaborative approach to systematic reviews of both trial results and individual participant data (IPD) is helping in establishing quickly and reliably which treatments are most effective and for which men. However, mHSPC is a complex disease and trials can be lengthy. Thus, parallel efforts will synthesise further IPD to identify early surrogate endpoints for overall survival and prognostic factors, to reduce the duration and improve the design of future trials. The STOPCAP M1 repository of IPD will be made available to other researchers for tackling new questions that might arise. The associated global, collaborative forum will aid strategic and harmonised development of the next generation of mHSPC trials (STOPCAP M1; http://www.stopcapm1.org). PATIENT SUMMARY: We report how a worldwide research effort will review results and anonymised data from advanced prostate cancer trials in new and different ways. We will work out, as quickly as possible, which advanced prostate cancer treatments are best and for which men. We will also find which measures of prostate cancer control and which cancer and patient characteristics can be used to shorten and improve trials of newer treatments. Finally, we describe how the data will help answer new questions about advanced prostate cancer and its treatments.
有许多正在进行的针对转移性激素敏感前列腺癌（mHSPC）的有前途的治疗方法的随机试验，但标准的系统评价可能无法及时或可靠地综合这些试验。我们展示了一种新的证据综合方法如何用于加快和改进 mHSPC 的治疗评估。这种更具前瞻性、动态性和协作性的方法，用于系统评价试验结果和个体参与者数据（IPD），有助于快速可靠地确定哪些治疗方法对哪些男性最有效。然而，mHSPC 是一种复杂的疾病，试验可能需要很长时间。因此，平行的努力将综合更多的 IPD，以确定总生存和预后因素的早期替代终点，从而缩短未来试验的时间并改进设计。将 IPD 的 STOPCAP M1 存储库提供给其他研究人员，以解决可能出现的新问题。相关的全球协作论坛将有助于制定下一代 mHSPC 试验的战略和协调发展（STOPCAP M1；http://www.stopcapm1.org）。患者总结：我们报告了一项全球性研究工作如何以新的和不同的方式审查晚期前列腺癌试验的结果和匿名数据。我们将尽快确定哪些晚期前列腺癌治疗方法对哪些男性最有效。我们还将找到哪些前列腺癌控制措施以及哪些癌症和患者特征可以用于缩短和改进新治疗方法的试验。最后，我们描述了这些数据将如何帮助回答有关晚期前列腺癌及其治疗的新问题。
