Bone Marrow Suppression and Recovery During Radionuclide Treatment
- Conditions
- Castration-resistant Prostate Cancer
- Registration Number
- NCT03247010
- Lead Sponsor
- Rigshospitalet, Denmark
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 68
- Metastatic castration resistant prostate cancer
- Planned to initiate Radium therapy
- Age > 18 years
- Able to understand study protocol and give informed consent
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Thrombocytopenia Within 1 year from inclusion CTCAE grade 1-5
OS within 1 year from inclusion Survival from first Radium-223
Bone markers Within 12 months from inclusion Changes in bone metabolic markers during Radium-223
- Secondary Outcome Measures
Name Time Method Leucopenia Within 1 year from inclusion CTCAE grade 1-5
Anemia Within 1 year from inclusion CTCAE grade 3-5
Trial Locations
- Locations (1)
Rigshospitalet
🇩🇰Copenhagen, Denmark