Observational Study for the Evaluation of Long-term Safety of Radium-223 Used for the Treatment of Metastatic Castration Resistant Prostate Cancer (REASSURE)

March 21, 2024 updated by: Bayer

Radium-223 Alpha Emitter Agent in Non-intervention Safety Study in mCRPC popUlation for Long-teRm Evaluation

Observational study in the routine clinical practice setting to evaluate the short and long term safety profile of Radium-223 in metastatic castration resistant prostate cancer patients and to evaluate the risk of developing second primary cancers.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1474

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

  • Argentina
      • Multiple Locations, Argentina
  • Austria
      • Multiple Locations, Austria
  • Belgium
      • Multiple Locations, Belgium
  • Canada
      • Multiple Locations, Canada
  • Colombia
      • Multiple Locations, Colombia
  • Czechia
      • Multiple Locations, Czechia
  • Denmark
      • Multiple Locations, Denmark
  • France
      • Multiple Locations, France
  • Germany
      • Multiple Locations, Germany
  • Greece
      • Multiple Locations, Greece
  • Israel
      • Multiple Locations, Israel
  • Italy
      • Multiple Locations, Italy
  • Luxembourg
      • Multiple Locations, Luxembourg
  • Mexico
      • Multiple Locations, Mexico
  • Netherlands
      • Multiple Locations, Netherlands
  • Portugal
      • Multiple Locations, Portugal
  • Spain
      • Multiple Locations, Spain
  • Sweden
      • Multiple Locations, Sweden
  • United Kingdom
      • Multiple Locations, United Kingdom
  • United States
    • Alaska
      • Anchorage, Alaska, United States
    • Arizona
      • Scottsdale, Arizona, United States
    • California
      • Daly City, California, United States
      • Long Beach, California, United States
      • Sacramento, California, United States
      • San Diego, California, United States
    • Colorado
      • Colorado Springs, Colorado, United States
    • Florida
      • Boca Raton, Florida, United States
      • Fort Myers, Florida, United States
      • Jacksonville, Florida, United States
      • Lakewood Ranch, Florida, United States
      • Plantation, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Decatur, Georgia, United States
    • Hawaii
      • Honolulu, Hawaii, United States
    • Illinois
      • Evanston, Illinois, United States
      • Warrenville, Illinois, United States
    • Kansas
      • Wichita, Kansas, United States
    • Kentucky
      • Ashland, Kentucky, United States
    • Louisiana
      • New Orleans, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Rockville, Maryland, United States
      • Towson, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Troy, Michigan, United States
    • Missouri
      • Saint Louis, Missouri, United States
    • Montana
      • Billings, Montana, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New Hampshire
      • Lebanon, New Hampshire, United States
    • New Jersey
      • Neptune, New Jersey, United States
      • Township, New Jersey, United States
    • New York
      • Buffalo, New York, United States
      • East Setauket, New York, United States
      • Lake Success, New York, United States
    • North Carolina
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Middleburg Heights, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Springfield, Oregon, United States
    • Pennsylvania
      • Abington, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States
      • Myrtle Beach, South Carolina, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Houston, Texas, United States
      • Lubbock, Texas, United States
      • San Antonio, Texas, United States
      • Temple, Texas, United States
    • Virginia
      • Charlottesville, Virginia, United States
      • Virginia Beach, Virginia, United States
    • Washington
      • Seattle, Washington, United States

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

Patients with histologically or cytologically confirmed castration resistant adenocarcinoma of the prostate with bone metastases for whom the treatment decision to Radium-223 has been made independent from and before patient enrolment in the study.

Description

Inclusion Criteria:

  • Treatment decision to Radium-223 needs to be made independent from and before patient enrollment in the study
  • Histologically or cytologically confirmed castration resistant adenocarcinoma of the prostate with bone metastases
  • Signed informed consent

Exclusion Criteria:

  • Previously treated with Radium-223 for any reason
  • Currently treated in clinical trials including other Radium-223 studies
  • Planned for the systemic concomitant use of other radiopharmaceuticals for treatment of prostate cancer or for other use

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 dichloride (Xofigo, BAY88-8223)
Single-arm cohort observational study with CRPC patients with bone metastasis treated with Radium-223.
Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
This is a non-interventional study, the drug is used in its authorized indication from commercial supply. The decision to treat with Radium-223 will be agreed upon between the physician and the patient independently and prior to providing the patient study information. Treatment with Radium-223 should follow the approved local product information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of developing second primary malignancies
Time Frame: From study start to 7 years post last dose of Radium-223
From study start to 7 years post last dose of Radium-223
Incidence of treatment-emergent SAEs
Time Frame: From study start up to 30 days after the last administration of Radium-223
From study start up to 30 days after the last administration of Radium-223
Incidence of drug-related treatment-emergent adverse events
Time Frame: From study start up to 30 days after the last administration of Radium-223
From study start up to 30 days after the last administration of Radium-223
Incidence of drug-related SAEs
Time Frame: From study start to 7 years post last dose of Radium-223
From study start to 7 years post last dose of Radium-223
Bone marrow suppression
Time Frame: From study start to 6 months post last dose of Radium-223
Therapeutic/prevention measures/treatment modalities, Gr. 3/4 hematological toxicities (up to 6 months after last administration), platelet or WBC < lower limit of normal during treatment +30 days will be followed to resolution (up to 6 months after last administration), and febrile neutropenia and hemorrhage for patients who start subsequent chemotherapy will be assessed.
From study start to 6 months post last dose of Radium-223

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From study start to 7 years post last dose of Radium-223
From study start to 7 years post last dose of Radium-223
The worst pain score and pain interference score over time as determined by patient responses on the "Brief pain inventory short form" (BPI-SF) questionnaire
Time Frame: From study start to 6 months post last dose of Radium-223
From study start to 6 months post last dose of Radium-223
Incidence of bone fractures
Time Frame: From study start to 7 years post last dose of Radium-223
From study start to 7 years post last dose of Radium-223
The number of bone associated events
Time Frame: From study start to 7 years post last dose of Radium-223
e.g. osteoporosis
From study start to 7 years post last dose of Radium-223

Collaborators and Investigators

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

Sponsor

Bayer

Investigators

  • Study Director: Bayer Study Director, Bayer

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.

General Publications

Helpful Links

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)

August 20, 2014

Primary Completion (Estimated)

August 2, 2024

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

May 15, 2014

First Submitted That Met QC Criteria

May 15, 2014

First Posted (Estimated)

May 19, 2014

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16913

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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