NCT03247010

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

November 9, 2022

Status Verified

November 1, 2022

Enrollment Period

2.3 years

First QC Date

August 7, 2017

Last Update Submit

November 4, 2022

Conditions

Castration-resistant Prostate Cancer

Outcome Measures

Primary Outcomes (3)

  • Thrombocytopenia

    CTCAE grade 1-5

    Within 1 year from inclusion

  • OS

    Survival from first Radium-223

    within 1 year from inclusion

  • Bone markers

    Changes in bone metabolic markers during Radium-223

    Within 12 months from inclusion

Secondary Outcomes (2)

  • Leucopenia

    Within 1 year from inclusion

  • Anemia

    Within 1 year from inclusion

Interventions

Blood samplingOTHER

Blood samples are taken before each cycle of Radium 223

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with metastatic castration-resistant prostate cancer, who initiate therapy with Radium-223 at Rigshospitalet, Copenhagen, Denmark

You may qualify if:

  • Metastatic castration resistant prostate cancer
  • Planned to initiate Radium therapy
  • Age \> 18 years
  • Able to understand study protocol and give informed consent

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

  • Fosbol MO, Jorgensen NR, Petersen PM, Kjaer A, Mortensen J. Biomarkers of bone metabolism in [223Ra] RaCl2 therapy - association with extent of disease and prediction of overall survival. EJNMMI Res. 2024 Oct 3;14(1):90. doi: 10.1186/s13550-024-01155-w.

    PMID: 39361218DERIVED

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jann Ø Mortensen, DMSc

    Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine & PET

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD student

Study Record Dates

First Submitted

August 7, 2017

First Posted

August 11, 2017

Study Start

June 20, 2017

Primary Completion

October 1, 2019

Study Completion

October 1, 2020

Last Updated

November 9, 2022

Record last verified: 2022-11

Locations

DK(1)