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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04587427
Recruitment Status : Not yet recruiting
First Posted : October 14, 2020
Last Update Posted : February 16, 2022
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment
Metastatic Castration-resistant Prostate Cancer (mCRPC) Drug: Radium 223 dichloride (Xofigo, BAY88-8223)

Study Design
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Study Type : Observational
Estimated Enrollment : 850 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Drug utilisatIon Study of Radium 223 Under Routine Clinical Practice in Europe
Estimated Study Start Date : March 31, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]
  4. Age (in years) [ Time Frame: Data will be collected from Nov 2013 to Dec 2020 ]
  5. 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 ]
  6. Time since first available prostate cancer diagnosis [ Time Frame: Data will be collected from Nov 2013 to Dec 2020 ]
  7. Confirmed diagnosis (yes/no) of mCRPC [ Time Frame: Data will be collected from Nov 2013 to Dec 2020 ]
  8. Prior use (yes/no) systemic therapy for CRPC [ Time Frame: Data will be collected from Nov 2013 to Dec 2020 ]
  9. Prior use (yes/no) systemic therapy for hormone-sensitive prostate cancer (HSPC) [ Time Frame: Data will be collected from Nov 2013 to Dec 2020 ]
  10. Presence of metastasis at baseline: bone or visceral [ Time Frame: Data will be collected from Nov 2013 to Dec 2020 ]
  11. 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 ]
  12. 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 ]
  13. Prior use of systemic corticosteroids: yes/no, since first diagnosis of PC [ Time Frame: Data will be collected from Nov 2013 to Dec 2020 ]
  14. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
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.
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04587427


Contacts
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Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

Locations
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Denmark
Many Locations
Multiple Locations, Denmark
Germany
Many Locations
Multiple Locations, Germany
Netherlands
Many Locations
Multiple Locations, Netherlands
Sponsors and Collaborators
Bayer
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04587427    
Other Study ID Numbers: 20702
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: February 16, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Prostatic Diseases
Radium Ra 223 dichloride
Antineoplastic Agents