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Completed

NCT Number: NCT04587427

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

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.

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Key information

Conditions

Bone Metastatic Castration-resistant Prostate Cancer

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Many Locations, Multiple Locations, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radium 223 dichloride (Xofigo, BAY88-8223)

Drug

Prescribed by physicians.

Primary outcomes

  1. The proportion of patients who use radium-223 in combination with abiraterone acetate

    Time frame: Data will be collected from Nov 2013 to Dec 2020

  2. The proportion of patients who use radium-223 in combination with other systemic therapies for mCRPC, except luteinising hormone-releasing hormone (LHRH) analogues

    Time frame: Data will be collected from Nov 2013 to Dec 2020

  3. The proportion of patients who use radium-223 without having received at least two prior lines of systemic therapy for mCRPC, except LHRH analogues

    Time frame: Data will be collected from Nov 2013 to Dec 2020

Secondary outcomes

  1. The difference between before and after the label change periods in the proportion of patients who use radium-223 in combination with abiraterone acetate

    Time frame: Data will be collected from Nov 2013 to Dec 2020

  2. 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

    Time frame: Data will be collected from Nov 2013 to Dec 2020

  3. 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

    Time frame: Data will be collected from Nov 2013 to Dec 2020

Other outcomes

  1. Descriptive summary of patient characteristics

    Time frame: Data will be collected from Nov 2013 to Dec 2020

    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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: DIRECT

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 14, 2020
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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