Bone Marrow Suppression and Recovery During Radionuclide Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Castration-resistant Prostate Cancer

Intervention / Treatment
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* Other: Blood sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Metastatic castration resistant prostate cancer Planned to initiate Radium therapy Age > 18 years Able to understand study protocol and give informed consent Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Blood sampling|Blood samples are taken before each cycle of Radium 223|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombocytopenia | CTCAE grade 1-5 | Within 1 year from inclusion | 
| OS | Survival from first Radium-223 | within 1 year from inclusion | 
| Bone markers | Changes in bone metabolic markers during Radium-223 | Within 12 months from inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leucopenia | CTCAE grade 1-5 | Within 1 year from inclusion | 
| Anemia | CTCAE grade 3-5 | Within 1 year from inclusion |