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 (DIRECT)

March 6, 2024 updated by: Bayer

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

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

1067

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Multiple Locations, Denmark
        • Many Locations
      • Multiple Locations, Germany
        • Many Locations
      • Multiple Locations, Netherlands
        • Many Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will include new users of radium-223 during the study periods captured in each data source. The study period will include time periods before and after the label change. The "before" period will start in November 2013, the month of radium-223 approval, and will end the in November 2017, the month when the first Direct Healthcare Professional Communication (DHCP) letter was sent. The "after" period will include an enrolment phase during which patients initiating radium-223 in each data source will be identified. The enrolment phase will last at least 1 year, starting in April 2019 (6 months after the label change), and will continue through a follow up phase of at least 6 months after the last new user of radium-223 is identified.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Radium-223
Subjects who received the treatment of radium-223 during the before or after label change study periods.
Prescribed by physicians.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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
Data will be collected from Nov 2013 to Dec 2020

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
Data will be collected from Nov 2013 to Dec 2020

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Data will be collected from Nov 2013 to Dec 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2021

Primary Completion (Actual)

May 30, 2023

Study Completion (Actual)

May 30, 2023

Study Registration Dates

First Submitted

October 13, 2020

First Submitted That Met QC Criteria

October 13, 2020

First Posted (Actual)

October 14, 2020

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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