Characterization of Bone Marrow Suppression and Recovery During Radionuclide Treatment Using Functional Tests of Thrombocytes and Hemostasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Thrombocytopenia
研究概览
简要总结
Radium-223-dichloride is approved therapy for patients with metastatic castration-resistant prostate cancer and bone metastases. More than 20 % of patients treated at Rigshospitalet develop bone marrow suppression as a side effect to Radium therapy The aim of the study is to examine biomarkers of bone marrow suppression and recovery during Radium therapy as well as markers of bone remodeling.
详细描述
Radium-223-dichloride is approved therapy for patients with metastatic castration-resistant prostate cancer and bone metastases. Therapy is administered intravenously every 4 weeks for up to 6 cycles. More than 20 % of patients treated at Rigshospitalet develop bone marrow suppression as a side effect to Radium therapy, which delays or excludes the patient from further oncological therapy. Especially thrombocytopenia is a frequent side-effect and can be long lasting.
The aim of the study is to examine whether biomarkers of bone marrow recovery (immature platelets, platelet volume, reticulocytes, red cell distribution width) can predict development of hematological toxicity during Radium therapy. Furthermore, to investigate whether these biomarkers can predict recovery from toxicity in patients who develop bone marrow suppression during therapy.
A secondary aim of the study is to evaluate whether dynamics in biomarkers of bone remodeling during Radium therapy is correlated to overall survival and time to symptomatic skeletal event. Optimally these biomarkers can aid in monitoring therapy.
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
- •Metastatic castration resistant prostate cancer
- •Planned to initiate Radium therapy
- •Age > 18 years
- •Able to understand study protocol and give informed consent
排除标准
- 未提供
结局指标
主要结局
Thrombocytopenia
时间窗: Within 1 year from inclusion
CTCAE grade 1-5
OS
时间窗: within 1 year from inclusion
Survival from first Radium-223
Bone markers
时间窗: Within 12 months from inclusion
Changes in bone metabolic markers during Radium-223
次要结局
- Leucopenia(Within 1 year from inclusion)
- Anemia(Within 1 year from inclusion)
研究者
Marie Øbro Fosbøl
MD, PhD student
Rigshospitalet, Denmark
