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COSMiC details

机译:宇宙细节

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A Canadian Observational Study in Metastatic Cancer of the Prostate: A Study of ZYTIGA Use in the Community Urology Setting. The COSMiC Prospective Prostate Cancer Registry.The purpose of this non-interventional, prospective, observational study is to temporally evaluate the impact of abiraterone acetate (ZYTIGA) therapy on Patient Reported Outcomes (PROs) and on clinical outcomes in the chemotherapy-naive metastatic castrate-resistant prostate cancer (mCRPC) population.Study participants must have a confirmed diagnosis of mCRPC according to medical history and have rising PSA levels or radiographic progression (documented by previous positive bone scan or metastatic lesions identified on CT or MRI) despite ongoing conventional ADT.Study participants will complete Quality of Life and Patient Satisfaction questionnaires longitudinally at defined time points. Safety and efficacy data, as well as levels of health care resource utilization associated with ZYTIGA therapy, will also be prospectively collected and analyzed.Once enrolled, study participants will be followed for a maximum of 72 weeks from the time of initiation of ZYTIGA treatment, or up to the time of early study withdrawal/termination.For additional information please contact Richard K. Plante at rplante@its.jnj.com
机译:加拿大前列腺转移性癌症的观察性研究:Zytiga在群体泌尿外科环境中的研究。宇宙前列腺癌登记处。这种非介入性,前瞻性的观察性研究的目的是在临时评估Abiraaterone醋酸盐(Zytiga)治疗对患者报告的结果(优点)的影响以及化疗 - 幼稚转移阉割中的临床结果 - 尽管常规的ADT,但仍然必须根据病史并具有上升的PSA水平或射线扫描或在CT或MRI中鉴定的阳性骨扫描或在CT或MRI中鉴定的转移性病变记录的诊断,并且仍然具有上升的PSA水平或射线扫描或在CT或MRI上鉴定的转移性病变的诊断诊断.Study参与者将在定义的时间点纵向地完成生活质量和患者满意度问卷。安全性和有效性数据,以及与Zytiga治疗相关的医疗资源利用水平,也将被预先收集和分析。注册,学习参与者将从Zytiga治疗开始时最多72周,或者达到早期学习的时间撤回/终止。对于其他资料,请联系Richard K.Plante在Rplante@its.jnj.com

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