DIRECT: 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
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Radium-223 Subjects who received the treatment of radium-223 during the before or after label change study periods. |
Drug: Radium 223 dichloride (Xofigo, BAY88-8223)
Prescribed by physicians.
|
Outcome Measures
Primary Outcome Measures
- The proportion of patients who use radium-223 in combination with abiraterone acetate [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 [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 [Data will be collected from Nov 2013 to Dec 2020]
Secondary Outcome Measures
- 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]
- 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]
- 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]
- Age (in years) [Data will be collected from Nov 2013 to Dec 2020]
- Calendar year when radium-223 was first prescribed/dispensed, as recorded in each data source [Data will be collected from Nov 2013 to Dec 2020]
- Time since first available prostate cancer diagnosis [Data will be collected from Nov 2013 to Dec 2020]
- Confirmed diagnosis (yes/no) of mCRPC [Data will be collected from Nov 2013 to Dec 2020]
- Prior use (yes/no) systemic therapy for CRPC [Data will be collected from Nov 2013 to Dec 2020]
- Prior use (yes/no) systemic therapy for hormone-sensitive prostate cancer (HSPC) [Data will be collected from Nov 2013 to Dec 2020]
- Presence of metastasis at baseline: bone or visceral [Data will be collected from Nov 2013 to Dec 2020]
- 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): [Data will be collected from Nov 2013 to Dec 2020]
- Prior use of bone-health agents (yes/no) since first diagnosis of PC [Data will be collected from Nov 2013 to Dec 2020]
- Prior use of systemic corticosteroids: yes/no, since first diagnosis of PC [Data will be collected from Nov 2013 to Dec 2020]
- History (diagnosis or treated for osteoporosis) of osteoporosis ever before the index date [Data will be collected from Nov 2013 to Dec 2020]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Many Locations | Multiple Locations | Denmark | ||
| 2 | Many Locations | Multiple Locations | Germany | ||
| 3 | Many Locations | Multiple Locations | Netherlands |
Sponsors and Collaborators
- Bayer
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 20702