check_circleStudy Completed

Bone metastatic castration-resistant prostate cancer

Bayer Identifier:

20702

ClinicalTrials.gov Identifier:

NCT04587427

EudraCT Number:

Not Available

EU CT Number:

Not Available
A study to learn more about how radium-223 is being used with other treatments in European patients who have not received radium-223 before

Trial purpose

In this study data from people with metastatic castration-resistant prostate cancer (mCRPC) with bone metastasis are studied. mCRPC is a prostate cancer which has spread to other parts of the body even when the amount of testosterone in the body was reduced. Bone metastasis is when the cancer has spread to the bones.
The study drug, radium-223, is currently available as a treatment for mCRPC with bone metastasis. But, its combination with certain other cancer treatments may lead to medical problems. Therefore the instructions about how doctors should use radium-223 with other cancer treatments were changed.
In this study, the researchers want to learn more about how doctors are now using radium-223 to treat patients with mCRPC and bone metastasis.
The participants in this study will include men in Denmark, Germany, or the Netherlands. They will not have received radium-223 before. They will have at least 6 months of medical records before starting treatment with radium-223. The researchers will collect the participants’ medical records up to December 2020.
The researchers will review information from the participants’ medical records and medical claims from hospitals where the participants received radium-223. They will look at the medical records of participants who first started receiving radium-223 before there were new instructions about using it with other cancer treatments. They will also look at the medical records of participants who first started receiving radium-223 after there were new instructions.
They will then count how many participants received other specific cancer treatments with radium-223. They will compare the results of the participants’ who received radium-223 before the new instructions and those who received it after the new instructions.
There are no required visits or tests in this study.

Key Participants Requirements

Sex

Male

Age

18 - N/A
  • - Patients who receive a first dispensing/administration of radium-223 during the before or after study period
    - Patients who have at least 6 months of continuous enrolment in the study databases before the first dispensing/administration of radium-223 (to allow for evaluation of recent medical history and medication use)
  • - Patients who used radium-223 ever before the start of the before study period

Trial summary

Enrollment Goal
1067
Trial Dates
May 2021 - May 2023
Phase
Phase 4
Could I Receive a placebo
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many LocationsMany Locations, Netherlands
Completed
Many LocationsMany Locations, Germany
Completed
Many LocationsMany Locations, Denmark

Primary Outcome

  • The proportion of patients who use radium-223 in combination with abiraterone acetate
    date_rangeTime Frame:
    Data will be collected from Nov 2013 to Dec 2020
  • The proportion of patients who use radium-223 in combination with other systemic therapies for mCRPC, except luteinising hormone-releasing hormone (LHRH) analogues
    date_rangeTime Frame:
    Data will be collected from Nov 2013 to Dec 2020
  • The proportion of patients who use radium-223 without having received at least two prior lines of systemic therapy for mCRPC, except LHRH analogues
    date_rangeTime Frame:
    Data will be collected from Nov 2013 to Dec 2020

Secondary Outcome

  • The difference between before and after the label change periods in the proportion of patients who use radium-223 in combination with abiraterone acetate
    date_rangeTime Frame:
    Data will be collected from Nov 2013 to Dec 2020
  • The difference between before and after the label change periods in the proportion of patients who use radium-223 in combination with other systemic therapies for mCRPC, except luteinising hormone-releasing hormone (LHRH) analogues
    date_rangeTime Frame:
    Data will be collected from Nov 2013 to Dec 2020
  • The difference between before and after the label change periods in the proportion of patients who use radium-223 without having received at least two prior lines of systemic therapy for mCRPC, except LHRH analogues
    date_rangeTime Frame:
    Data will be collected from Nov 2013 to Dec 2020

Trial design

Drug utilisatIon study of Radium 223 under routine clinical practice in Europe
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

​Click here for access to information about Bayer’s transparency standards and Bayer studies.