Characterization of Bone Marrow Suppression and Recovery During Radionuclide Treatment Using Functional Tests of Thrombocytes and Hemostasis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Castration-resistant Prostate Cancer
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Thrombocytopenia
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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.
Investigators
Marie Øbro Fosbøl
MD, PhD student
Rigshospitalet, Denmark
Eligibility Criteria
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
- Not provided
Outcomes
Primary Outcomes
Thrombocytopenia
Time Frame: Within 1 year from inclusion
CTCAE grade 1-5
OS
Time Frame: within 1 year from inclusion
Survival from first Radium-223
Bone markers
Time Frame: Within 12 months from inclusion
Changes in bone metabolic markers during Radium-223
Secondary Outcomes
- Leucopenia(Within 1 year from inclusion)
- Anemia(Within 1 year from inclusion)