A Prospective, Single Product, Observational Registry Involving Patients Presenting With Locally Advanced or Metastatic Prostate Cancer Receiving Eligard as Androgen Deprivation Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 354
- 试验地点
- 36
- 主要终点
- Determine the percentage of patients that will achieve a hormone refractory status at 3 years after initiation of Androgen Deprivation Treatment with Eligard®.
研究概览
简要总结
The objective of this registry is to collect data on patient demographics, medical history, change in prostate, bone and overall health of the patients receiving androgen ablation treatment using Eligard. Data collected through this national registry program provides an opportunity to increase knowledge of efficacy and safety of the long term treatment with Eligard, provide a platform to better identify patient segments for the therapy with Eligard®. Furthermore registries are the only tools to accurately capture rare adverse events.
详细描述
354 patients were enrolled in this study. Only 88 patients completed the study.
For those patients completing the three years of data collection, 10% were considered Castrate Resistant and remained on Eligard®. For those patients not completing 3 years of follow-up, 8.8% were considered Castrate Resistant and did not continue in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients > 18 years of age.
- •Histologically confirmed diagnosis of locally Advanced or Metastatic Prostate Cancer.
- •Patient starting an androgen deprivation therapy with Eligard at 3 or 4 month treatment frequency per standard of care.
- •Signed written informed consent.
排除标准
- •Prior ADT (within 6 months).
- •Any concurrent condition that would make it undesirable, in the physician's opinion, for the subject to participate in the study or would jeopardize compliance with the protocol.
- •Life expectancy less than 2 years.
结局指标
主要结局
Determine the percentage of patients that will achieve a hormone refractory status at 3 years after initiation of Androgen Deprivation Treatment with Eligard®.
时间窗: 3 Years
次要结局
- Collect data on patient demographics, medical history, and change in prostate-, bone- and overall health of the patients receiving androgen ablation treatment using Eligard®.(3 years)
- Collect referral data if the patient was referred to a medical oncologist during treatment.(3 years)
- Determine what baseline patient characteristics are associated with becoming hormone refractory at 3 years.(3 years)