在实际医疗环境中评估瑞格列奈治疗前列腺癌的效果:OPTYX 研究方案。

IF 3 4区 医学 Q2 ONCOLOGY
Future oncology Pub Date : 2024-04-01 Epub Date: 2024-03-15 DOI:10.2217/fon-2023-0748
Daniel E Spratt, Tanya Dorff, Rana R McKay, Benjamin H Lowentritt, Mark Fallick, Sergio C Gatoulis, Scott C Flanders, Ashley E Ross
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引用次数: 0

摘要

OPTYX 是一项多中心、前瞻性、观察性研究,旨在通过收集日常护理环境中的临床和患者报告结果,进一步了解晚期前列腺癌患者接受口服雄激素剥夺疗法 (ADT) 瑞格列奈 (ORGOVYX®) 治疗的实际体验。该研究的目标是招募 1000 名获得同意的晚期前列腺癌患者,这些患者来自美国各地的社区、学术机构和政府运营的临床实践机构。在计划的时间节点,有关治疗模式、依从性和安全性以及治疗终止后的健康结果和与健康相关的生活质量(HRQOL)的真实世界数据分析将发表在同行评审的科学期刊上,并在相关会议上发表。这项研究将为从业人员和研究人员了解瑞格列奈的安全性和有效性提供真实世界的数据。临床试验注册:NCT05467176(ClinicalTrials.gov)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Evaluating relugolix for the treatment of prostate cancer in real-world settings of care: the OPTYX study protocol.

OPTYX is a multi-center, prospective, observational study designed to further understand the actual experience of patients with advanced prostate cancer treated with relugolix (ORGOVYX®), an oral androgen deprivation therapy (ADT), by collecting clinical and patient-reported outcomes from routine care settings. The study aims to enroll 1000 consented patients with advanced prostate cancer from community, academic and government operated clinical practices across the USA. At planned timepoints, real-world data analysis on treatment patterns, adherence and safety as well as health outcomes and health-related quality-of-life (HRQOL) after treatment discontinuation will be published in scientific peer-reviewed journals and presented at relevant conferences. This study will provide real-world data for practitioners and researchers in their understanding of the safety and effectiveness of relugolix. Clinical Trial Registration: NCT05467176 (ClinicalTrials.gov).

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来源期刊
Future oncology
Future oncology ONCOLOGY-
CiteScore
5.40
自引率
3.00%
发文量
335
审稿时长
4-8 weeks
期刊介绍: Future Oncology (ISSN 1479-6694) provides a forum for a new era of cancer care. The journal focuses on the most important advances and highlights their relevance in the clinical setting. Furthermore, Future Oncology delivers essential information in concise, at-a-glance article formats - vital in delivering information to an increasingly time-constrained community. The journal takes a forward-looking stance toward the scientific and clinical issues, together with the economic and policy issues that confront us in this new era of cancer care. The journal includes literature awareness such as the latest developments in radiotherapy and immunotherapy, concise commentary and analysis, and full review articles all of which provide key findings, translational to the clinical setting.
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