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Bone Marrow Suppression and Recovery During Radionuclide Treatment

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT03247010
Collaborator
(none)
68
Enrollment
1
Location
39.4
Actual Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Blood sampling

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.

Study Design

Study Type:
Observational
Actual Enrollment :
68 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Characterization of Bone Marrow Suppression and Recovery During Radionuclide Treatment Using Functional Tests of Thrombocytes and Hemostasis
Actual Study Start Date :
Jun 20, 2017
Actual Primary Completion Date :
Oct 1, 2019
Actual Study Completion Date :
Oct 1, 2020

Outcome Measures

Primary Outcome Measures

  1. Thrombocytopenia [Within 1 year from inclusion]

    CTCAE grade 1-5

Secondary Outcome Measures

  1. Leucopenia [Within 1 year from inclusion]

    CTCAE grade 1-5

  2. Anemia [Within 1 year from inclusion]

    CTCAE grade 3-5

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rigshospitalet Copenhagen Denmark 2100

Sponsors and Collaborators

  • Rigshospitalet, Denmark

Investigators

  • Study Director: Jann Ø Mortensen, DMSc, Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine & PET

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marie Øbro Fosbøl, MD, PhD student, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT03247010
Other Study ID Numbers:
  • Radium-Trombocyt
First Posted:
Aug 11, 2017
Last Update Posted:
Nov 23, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Nov 23, 2020