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临床试验/NCT03247010
NCT03247010已完成不适用

Characterization of Bone Marrow Suppression and Recovery During Radionuclide Treatment Using Functional Tests of Thrombocytes and Hemostasis

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2017年6月20日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marie Øbro Fosbøl

MD, PhD student

Rigshospitalet, Denmark

研究点 (1)

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