check_circleStudy Completed

Metastatic castration-resistant prostate cancer

Bayer Identifier:
16913
ClinicalTrials.gov Identifier:
NCT02141438
EudraCT Number:
Not Available
EU CT Number:
Not Available
Observational study for the evaluation of long-term safety of Radium-223 used for the treatment of metastatic castration resistant prostate cancer

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

18 - N/A
  • - 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
  • - 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

Trial summary

Enrollment Goal
1472
Trial Dates
August 2014 - October 2024
Phase
Phase 4
Could I Receive a placebo
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Active, not recruiting
Omaha, United States
Completed
Many Locations, Germany
Completed
Many Locations, United Kingdom
Completed
Many Locations, France
Active, not recruiting
Many Locations, Italy
Completed
Many Locations, Spain
Completed
Many Locations, Belgium
Completed
Many Locations, Netherlands
Completed
Many Locations, Sweden
Completed
Many Locations, Denmark
Withdrawn
Many Locations, Norway
Active, not recruiting
Many Locations, Czech Republic
Completed
Many Locations, Israel
Completed
Many Locations, Austria
Active, not recruiting
Many Locations, Luxembourg
Completed
Many Locations, Greece
Completed
Many locations, Mexico
Active, not recruiting
Many Locations, Portugal
Completed
Many Locations, Argentina
Withdrawn
Many Locations, Taiwan
Withdrawn
Many Locations, Singapore
Active, not recruiting
Lake Success, United States
Completed
Anchorage, United States
Withdrawn
Homewood, United States
Active, not recruiting
Springfield, United States
Completed
Plantation, United States
Completed
Fort Myers, United States
Completed
Scottsdale, United States
Completed
Lakewood Ranch, United States
Withdrawn
Syracuse, United States
Active, not recruiting
Myrtle Beach, United States
Active, not recruiting
Troy, United States
Active, not recruiting
Nashville, United States
Active, not recruiting
Middleburg Heights, United States
Completed
San Diego, United States
Active, not recruiting
New Orleans, United States
Active, not recruiting
Virginia Beach, United States
Active, not recruiting
Long Beach, United States
Completed
Colorado Springs, United States
Active, not recruiting
Boston, United States
Completed
Daly City, United States
Completed
Billings, United States
Completed
Warrenville, United States
Active, not recruiting
Boca Raton, United States
Completed
Lubbock, United States
Completed
Wichita, United States
Active, not recruiting
Temple, United States
Active, not recruiting
Oklahoma City, United States
Withdrawn
Baltimore, United States
Active, not recruiting
East Setauket, United States
Active, not recruiting
Houston, United States
Active, not recruiting
Seattle, United States
Completed
Sacramento, United States
Active, not recruiting
Saint Louis, United States
Withdrawn
Urbana, United states
Active, not recruiting
San Antonio, United States
Completed
Abington, United States
Completed
Many Locations, Canada
Active, not recruiting
Buffalo, United States
Active, not recruiting
Winston-Salem, United States
Active, not recruiting
Atlanta, United States
Active, not recruiting
Baltimore, United States
Active, not recruiting
Township, United States
Completed
Charleston, United States
Active, not recruiting
Evanston, United States
Active, not recruiting
Winston-Salem, United States
Active, not recruiting
Honolulu, United States
Completed
Charlottesville, United States
Completed
St. Louis, United States
Active, not recruiting
Many Locations, Colombia
Active, not recruiting
Rockville, United States
Active, not recruiting
Neptune, United States
Withdrawn
Maywood, United States
Completed
Decatur, United States
Active, not recruiting
Seattle, United States
Active, not recruiting
Jacksonville, United States
Active, not recruiting
Towson, United States
Active, not recruiting
Lebanon, United States
Active, not recruiting
Ashland, United States
Withdrawn
Many Locations, Brazil

Primary Outcome

  • Number of participants with second primary malignancies (SPM)
    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
    date_rangeTime 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
  • Number of participants with treatment-emergent serious adverse events (SAEs)
    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.
    date_rangeTime 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
  • Number of participants with drug-related treatment-emergent adverse events
    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.
    date_rangeTime 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
  • Number of participants with drug-related SAEs
    All drug-related SAEs were collected up to 7 years after the last administration of radium-223.
    date_rangeTime 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
  • Number of participants with therapeutic or preventive treatments for bone marrow suppression
    Bone marrow suppression relevant treatments for participants with subsequent chemotherapy (e.g., blood transfusion/erythropoietin/colony growth stimulating factors)
    date_rangeTime 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
  • Incidences of post‑radium‑223 treatment CTCAE grade 3/4 hematological toxicities based on bone marrow suppression
    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
    date_rangeTime Frame:
    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)
    Participants with a platelet count or WBC less than the lower limit of normal at 6 months post last dose of Radium- 223
    date_rangeTime Frame:
    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
    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.
    date_rangeTime Frame:
    From first dose of subsequent chemotherapy up to 6 months (up to 183 days) after the last administration of chemotherapy

Secondary Outcome

  • Overall survival
    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.
    date_rangeTime 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
  • Worst pain score over time as determined by patient responses on the "Brief pain inventory short form" (BPI-SF) questionnaire
    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
    date_rangeTime 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 pain interference score over time as determined by patient responses on the "Brief pain inventory short form" (BPI-SF) questionnaire
    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
    date_rangeTime 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
  • Percentage of participants with bone fractures
    Bone fractures were identified by MedDRA HLGTs: Fractures: HLGT = “Fractures”.
    date_rangeTime 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
  • Percentage of participants with bone associated events
    Bone associated events were identified by MedDRA HLGTs: Bone associated events: HLGT = “Bone disorders (excl congenital and fractures)”
    date_rangeTime 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

Trial design

Radium-223 alpha Emitter Agent in non-intervention Safety Study in mCRPC popUlation for long-teRm Evaluation
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

​Click here for access to information about Bayer’s transparency standards and Bayer studies.