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Bone Marrow Suppression and Recovery During Radionuclide Treatment

Rigshospitalet logo

Rigshospitalet

Status

Completed

Conditions

Castration-resistant Prostate Cancer

Treatments

Other: Blood sampling

Study type

Observational

Funder types

Other

Identifiers

NCT03247010
Radium-Trombocyt

Details and patient eligibility

About

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.

Full 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.

Enrollment

68 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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