An observational study in Castration-resistant Prostate Cancer, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-09.
Sponsored by Rigshospitalet, Denmark · Observational
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.
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 68 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.
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Patients with metastatic castration-resistant prostate cancer, who initiate therapy with Radium-223 at Rigshospitalet, Copenhagen, Denmark
Exclusion Criteria:
Blood samples are taken before each cycle of Radium 223
Thrombocytopenia
CTCAE grade 1-5
Time frame: Within 1 year from inclusion
OS
Survival from first Radium-223
Time frame: within 1 year from inclusion
Bone markers
Changes in bone metabolic markers during Radium-223
Time frame: Within 12 months from inclusion
Leucopenia
CTCAE grade 1-5
Time frame: Within 1 year from inclusion
Anemia
CTCAE grade 3-5
Time frame: Within 1 year from inclusion
Plan to share: Undecided
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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Rigshospitalet, Denmark