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Completed

NCT Number: NCT03247010

Bone Marrow Suppression and Recovery During Radionuclide Treatment

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.

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Key information

Conditions

Castration-resistant Prostate Cancer

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Other

Blood samples are taken before each cycle of Radium 223

Primary outcomes

  1. Thrombocytopenia

    Time frame: Within 1 year from inclusion

    CTCAE grade 1-5

  2. OS

    Time frame: within 1 year from inclusion

    Survival from first Radium-223

  3. Bone markers

    Time frame: Within 12 months from inclusion

    Changes in bone metabolic markers during Radium-223

Secondary outcomes

  1. Leucopenia

    Time frame: Within 1 year from inclusion

    CTCAE grade 1-5

  2. Anemia

    Time frame: Within 1 year from inclusion

    CTCAE grade 3-5

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Aug 11, 2017
Registry last updated
Nov 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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