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Bone Marrow Suppression and Recovery During Radionuclide Treatment

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03247010
Enrollment
68
Registered
2017-08-11
Start date
2017-06-20
Completion date
2020-10-01
Last updated
2022-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Castration-resistant Prostate Cancer

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.

Interventions

OTHERBlood sampling

Blood samples are taken before each cycle of Radium 223

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
ThrombocytopeniaWithin 1 year from inclusionCTCAE grade 1-5
OSwithin 1 year from inclusionSurvival from first Radium-223
Bone markersWithin 12 months from inclusionChanges in bone metabolic markers during Radium-223

Secondary

MeasureTime frameDescription
AnemiaWithin 1 year from inclusionCTCAE grade 3-5
LeucopeniaWithin 1 year from inclusionCTCAE grade 1-5

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026