NCT02066961已完成不适用
A Prospective, Longitudinal, Multinational, Observational Study to Describe Patterns of Care and Outcomes of Men Who Are at High Risk for Poor Clinical Outcomes After Experiencing Biochemical Failure Following Definitive Prostate Cancer Therapy, Men With Castration-Resistant Prostate Cancer and Men With Metastatic Prostate Cancer at Initial Diagnosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,533
- 试验地点
- 1
- 主要终点
- Patterns of disease management
研究概览
简要总结
The purpose of this study is to describe patterns in disease management and to describe clinical outcomes, as well as to identify factors influencing physician treatment decisions including reason(s) for treatment choices and trigger(s) for treatment changes and to document healthcare resource utilization used to manage treatment-related complications.
详细描述
Each subject will be followed from the time of enrollment for a minimum of 3 years and a maximum of up to 6 years or until death, whichever comes first.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of prostate adenocarcinoma
- •Will receive a new intervention at the time of study entry, for the treatment of:
- •Biochemical failure after initial curative-intent surgery (radical prostatectomy) or radiotherapy (external-beam radiation therapy, brachytherapy, or both) and a PSA doubling time of one year or less or a confirmed PSA of ≥ 50 ng/mL (2 consecutive values) within 6 months prior to study entry; or
- •Castration-resistant prostate cancer; or
- •Metastatic prostate cancer at initial diagnosis of prostate cancer
排除标准
- •Prior treatment of metastatic castration-resistant prostate cancer with systemic chemotherapy
- •Life expectancy of <1 year due to comorbidities
结局指标
主要结局
Patterns of disease management
时间窗: up to 72 months
Description of disease assessment methods, physician referral patterns and treatments
Clinical outcomes
时间窗: up to 72 months
Evidence of disease progression and development of symptomatic disease
次要结局
- Factors influencing physician treatment decisions(up to 72 months)
- Documentation of healthcare resource utilization used to manage treatment-related complications(up to 72 months)
研究者
研究点 (1)
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