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

Bone Metastatic Castration-resistant Prostate Cancer Clinical Trial

— DIRECT  

Official title:

Drug utilisatIon Study of Radium 223 Under Routine Clinical Practice in Europe

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04587427
• Other study ID #: 20702
• Status: Completed
• Start date: May 15, 2021
• Est. completion date: May 30, 2023

Study information

• Verified date: March 2024
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1067
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Patients who used radium-223 ever before the start of the before study period

Related Conditions & MeSH terms

• Bone Metastatic Castration-resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Radium 223 dichloride (Xofigo, BAY88-8223)
Prescribed by physicians.

Locations

Country	Name	City	State
Denmark	Many Locations	Multiple Locations
Germany	Many Locations	Multiple Locations
Netherlands	Many Locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Denmark,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Descriptive summary of patient characteristics	Including: Age (in years); Calendar year when radium-223 was first prescribed/dispensed, as recorded in each data source; Time since first available prostate cancer diagnosis; Confirmed diagnosis (yes/no) of mCRPC; Prior use (yes/no) systemic therapy for CRPC; Prior use (yes/no) systemic therapy for hormone-sensitive prostate cancer (HSPC); Presence of metastasis at baseline: bone or visceral; Total level of serum alkaline phosphatase, when available: as U/L and categorised as above or below a threshold (e.g., < 220 U/L and = 220; U/L): Prior use of bone-health agents (yes/no) since first diagnosis of PC; Prior use of systemic corticosteroids: yes/no, since first diagnosis of PC; History (diagnosis or treated for osteoporosis) of osteoporosis ever before the index date	Data will be collected from Nov 2013 to Dec 2020
Primary	The proportion of patients who use radium-223 in combination with abiraterone acetate		Data will be collected from Nov 2013 to Dec 2020
Primary	The proportion of patients who use radium-223 in combination with other systemic therapies for mCRPC, except luteinising hormone-releasing hormone (LHRH) analogues		Data will be collected from Nov 2013 to Dec 2020
Primary	The proportion of patients who use radium-223 without having received at least two prior lines of systemic therapy for mCRPC, except LHRH analogues		Data will be collected from Nov 2013 to Dec 2020
Secondary	The difference between before and after the label change periods in the proportion of patients who use radium-223 in combination with abiraterone acetate		Data will be collected from Nov 2013 to Dec 2020
Secondary	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		Data will be collected from Nov 2013 to Dec 2020
Secondary	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		Data will be collected from Nov 2013 to Dec 2020

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