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

October 7, 2025 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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1472

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 Rch, 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
      • St Louis, Missouri, United States
    • Montana
      • Billings, Montana, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New Hampshire
      • Lebanon, New Hampshire, United States
    • New Jersey
      • Neptune City, 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
Number of Participants With Second Primary Malignancies (SPM)
Time Frame: From the initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 7 years after the last dose of Radium-223
Second primary malignancies (SPMs) are defined as new malignancies unrelated to prostate cancer or progression of prostate cancer. All types of SPMs will be collected irrespectively of their relationship to Radium-223. All reported SPMs will be summarized as assessed by the physician
From the initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 7 years after the last dose of Radium-223
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
Time Frame: From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223
Treatment-emergent was defined as any event arising or worsening on the day of or after start of radium-223 until 30 days after last injection.
From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223
Number of Participants With Drug-related Treatment-emergent Adverse Events
Time Frame: From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223
Treatment-emergent was defined as any event arising or worsening on the day of or after start of radium-223 until 30 days after last injection.
From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 30 days after the last administration of Radium-223
Number of Participants With Drug-related SAEs
Time Frame: From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks), up to 7 years after the last dose of Radium-223
All drug-related SAEs were collected up to 7 years after the last administration of radium-223.
From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks), up to 7 years after the last dose of Radium-223
Number of Participants With Therapeutic or Preventive Treatments for Bone Marrow Suppression
Time Frame: From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 6 months after last dose of Radium-223
Bone marrow suppression relevant treatments for participants with subsequent chemotherapy (e.g., blood transfusion/erythropoietin/colony growth stimulating factors)
From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 6 months after last dose of Radium-223
Incidences of Post-Radium-223 Treatment CTCAE Grade 3/4 Hematological Toxicities Based on Bone Marrow Suppression
Time Frame: From last Radium-223 dose up to 6 months post last dose of Radium-223
Hematological toxicities were summarized by the Common Terminology Criteria for Adverse Events (CTCAE) coding system and the worst grade. The grading system ranges from Grade 1 (mild) to Grade 5 (death). The percentage of participants with post-radium-223 treatment CTCAE grade 3 or 4 hematological toxicities that occurred within 183 days from last radium-223 injection are reported
From last Radium-223 dose up to 6 months post last dose of Radium-223
Bone Marrow Suppression: Number of Participants With Abnormal Platelet Count or White Blood Cell Count (WBC)
Time Frame: From 30 days after last dose of Radium-223 up to 6 months after last dose
Participants with a platelet count or WBC less than the lower limit of normal at 6 months post last dose of Radium- 223
From 30 days after last dose of Radium-223 up to 6 months after last dose
Bone Marrow Suppression: Number of Participants Who Underwent Subsequent Chemotherapy That Experienced Febrile Neutropenia or Hemorrhage
Time Frame: From first dose of subsequent chemotherapy up to 6 months (up to 183 days) after the last administration of chemotherapy
Participants who receive subsequent cytotoxic chemotherapy were followed for the development of febrile neutropenia and hemorrhage up to 6 months after the last administration of chemotherapy at a frequency based on local clinical practice.
From first dose of subsequent chemotherapy up to 6 months (up to 183 days) after the last administration of chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 7 years after the last dose of Radium-223
Overall survival was defined as the time interval from the start of Radium-223 therapy to death due to any cause. Patients whose death was not confirmed at the time of data-cut were censored at the last date known to be alive.
From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 7 years after the last dose of Radium-223
Worst Pain Score Over Time as Determined by Patient Responses on the "Brief Pain Inventory Short Form" (BPI-SF) Questionnaire
Time Frame: From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 6 months after the last dose of Radium-223
The Brief pain inventory short form (BPI-SF) questionnaire was used to assess pain severity on a scale from 0 (no pain) to 10 (worst pain). The BPI-SF questionnaire was requested prior to each injection of Radium-223 and also used at each follow-up visit until 6 months after the last injection of Radium-223. The pain severity score was calculated per visit. Completion of the BPI-SF questionnaire by the patient was voluntary. Since this is an observational study, the treatment regimen may not necessarily follow the recommended schedule of one cycle every 4 weeks for all participants
From initiation of Radium-223 (treatment period up to 6 months which includes 6 cycles every 4 weeks) up to 6 months after the last dose of Radium-223
The Pain Interference Score Over Time as Determined by Patient Responses on the "Brief Pain Inventory Short Form" (BPI-SF) Questionnaire
Time Frame: From initiation of Radium-223 (treatment period up to 6 months which includes 4 cycles every 4 weeks) up to 6 months after the last dose of Radium-223
The Brief pain inventory short form (BPI-SF) questionnaire was used to assess pain interference on a scale from 0 (does not interfere) to 10 (completely interferes). The BPI-SF questionnaire was requested prior to each injection of Radium-223 and also used at each follow-up visit until 6 months after the last injection of Radium-223. The pain interference score was calculated per visit. Completion of the BPI-SF questionnaire by the patient was voluntary Since this is an observational study, the treatment regimen may not necessarily follow the recommended schedule of one cycle every 4 weeks for all participants
From initiation of Radium-223 (treatment period up to 6 months which includes 4 cycles every 4 weeks) up to 6 months after the last dose of Radium-223
Percentage of Participants With Bone Fractures
Time Frame: From initiation of Radium-223 (treatment period up to 6 months which includes 6 cyles every 4 weeks) up to 7 years post last dose of Radium-223
Bone fractures were identified by MedDRA HLGTs: Fractures: HLGT = "Fractures".
From initiation of Radium-223 (treatment period up to 6 months which includes 6 cyles every 4 weeks) up to 7 years post last dose of Radium-223
Percentage of Participants With Bone Associated Events
Time Frame: From initiation of Radium-223 (treatment period up to 6 months which includes 6 cyles every 4 weeks) up to 7 years post last dose of Radium-223
Bone associated events were identified by MedDRA HLGTs: Bone associated events: HLGT = "Bone disorders (excl congenital and fractures)"
From initiation of Radium-223 (treatment period up to 6 months which includes 6 cyles every 4 weeks) up 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 (Actual)

August 2, 2024

Study Completion (Actual)

October 24, 2024

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 (Estimated)

October 16, 2025

Last Update Submitted That Met QC Criteria

October 7, 2025

Last Verified

October 1, 2025

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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