Registry of Treatment Outcomes in a Non-study Population of Symptomatic Metastasized Castration Resistant Prostate Cancer (mCRPC) Patients Treated With Radium-223
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Efficacy of treatment on pain outcomes, as mentioned by the patient
研究概览
简要总结
This registry aims to evaluate the efficacy of Rad-223 treatment in a non-study population of CRPC patients treated earlier with Docetaxel and patients not treated earlier with Docetaxel and efficacy of the first subsequent therapy. The indication for treatment with Radium-223 will be at the physician's decision. All patients treated with Radium-223 can be included in this registry. The registry only dictates the collection of base line characteristics, expansion of regular blood tests and patient reported pain scores.
详细描述
Serum and blood markers of bone metabolism will be evaluated at Base Line, 1st, 2nd, 3rd and 6th (or last) Radium- 223 treatment. Every blood draw prior to Radium-223 treatment At baseline, tests include (but not restricted to): Testosterone, vitamin D-25-OH (Calciferol), C-reactive protein, Rank Ligand, IL6, BSAF, P1NP and CTX. Patients need to be fasting when blood is collected. (2x8,5 ml gel tube; Limited to 100 patients in selected centres). Before 2nd, 3rd, 4th and 6th (or last) Radium-223 treatment, tests include (but not restricted to): C-reactive protein, Rank, Ligand, IL6, BSAF, P1NP and CTX. Patients need to be fasting when blood is collected. (2x8,5 ml gel tube; Limited to 100 patients in selected centers).
Moreover, levels of osteoclast precursors (CD34+) will be evaluated (10 ml heparinized blood) prior to the first Radium-223 treatment, 3rd and last treatment (Limited to 100 patients in selected centres).
All above-mentioned blood collections will be from the same venipuncture as standard clinical labs. Experimental assessments will be evaluated for their value as biomarkers of treatment outcome.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •At the physicians discretion
- •Age 18 year and older.
- •Written informed consent
排除标准
- •Previous treatment with Radium-
- •Participation in another Radium-223 study.
结局指标
主要结局
Efficacy of treatment on pain outcomes, as mentioned by the patient
时间窗: through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)
Evaluate Radium-223 treatment efficacy by patient, by several questionnaires (FACT-P, BPI-S and use of painmedication).
Efficacy of treatment by patient records
时间窗: through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment)
But also by patient records (records of bonescans, CT scans, blood measurements, out-patient clinic visits). All of these assessments will be combined to come to a final reported value (Progressive disease, stable disease, partial remission or complete remission)
次要结局
- Subsequent therapy after Radium-223: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment))
- Biomarkers(through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment))
- Symptomatic Skeletal Event(through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment))
- Clinical Parameters assessed by the WHO PS.(through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment))
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(through study completion, an average of 1 year. (6 months treatment, 6 months follow-up after end of treatment))