Bone Marrow Suppression and Recovery During Radionuclide Treatment

Castration-resistant Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03247010
• Other study ID #: Radium-Trombocyt
• Status: Completed
• Start date: June 20, 2017
• Est. completion date: October 1, 2020

Study information

• Verified date: November 2022
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Castration-resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Blood sampling
Blood samples are taken before each cycle of Radium 223

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thrombocytopenia	CTCAE grade 1-5	Within 1 year from inclusion
Primary	OS	Survival from first Radium-223	within 1 year from inclusion
Primary	Bone markers	Changes in bone metabolic markers during Radium-223	Within 12 months from inclusion
Secondary	Leucopenia	CTCAE grade 1-5	Within 1 year from inclusion
Secondary	Anemia	CTCAE grade 3-5	Within 1 year from inclusion