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

Overview

The patients in this study had their prostate cancer spread even when the amount of testosterone in the body was reduced. This is also known as metastatic castration-resistant prostate cancer (mCRPC). The study drug, radium-223, is currently available as a treatment for mCRPC. But, in a clinical trial, researchers found that participants of that trial had medical problems when receiving radium-223 with certain other cancer treatments. This led researchers to change the instructions about how doctors should use radium-223 with other cancer treatments. In this study, the researchers want to learn more about how doctors are now using radium-223 to treat patients with mCRPC. There are no required visits or tests in this study. The researchers in this study will review information from the patients' medical records and medical claims from hospitals where the patients received radium-223. The patients 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 look at the medical records of patients 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 patients who first started receiving radium-223 after there were new instructions. The researchers will collect the patients' medical records up to December 2020. They will then count how many patients received other specific cancer treatments with radium-223. They will compare the results of the patients who received radium-223 before the new instructions and those who received it after the new instructions.

Full Title of Study: “Drug utilisatIon Study of Radium 223 Under Routine Clinical Practice in Europe”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 1, 2023

Interventions

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

Arms, Groups and Cohorts

  • Radium-223
    • Subjects who received the treatment of radium-223 during the before or after label change study periods.

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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
  • 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 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
    • Time 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
    • Time 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
    • Time Frame: Data will be collected from Nov 2013 to Dec 2020
  • Age (in years)
    • Time Frame: 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
    • Time Frame: Data will be collected from Nov 2013 to Dec 2020
  • Time since first available prostate cancer diagnosis
    • Time Frame: Data will be collected from Nov 2013 to Dec 2020
  • Confirmed diagnosis (yes/no) of mCRPC
    • Time Frame: Data will be collected from Nov 2013 to Dec 2020
  • Prior use (yes/no) systemic therapy for CRPC
    • Time Frame: Data will be collected from Nov 2013 to Dec 2020
  • Prior use (yes/no) systemic therapy for hormone-sensitive prostate cancer (HSPC)
    • Time Frame: Data will be collected from Nov 2013 to Dec 2020
  • Presence of metastasis at baseline: bone or visceral
    • Time Frame: 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):
    • Time Frame: Data will be collected from Nov 2013 to Dec 2020
  • Prior use of bone-health agents (yes/no) since first diagnosis of PC
    • Time Frame: Data will be collected from Nov 2013 to Dec 2020
  • Prior use of systemic corticosteroids: yes/no, since first diagnosis of PC
    • Time Frame: Data will be collected from Nov 2013 to Dec 2020
  • History (diagnosis or treated for osteoporosis) of osteoporosis ever before the index date
    • Time Frame: Data will be collected from Nov 2013 to Dec 2020

Participating in This Clinical Trial

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
  • Gender Eligibility: Male

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Bayer
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Contact(s)
      • Bayer Clinical Trials Contact, (+)1-888-84 22937, clinical-trials-contact@bayer.com

    Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

    At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.