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
1474
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Withdrawn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Withdrawn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Withdrawn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Withdrawn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

  • Incidence of developing second primary malignancies
    date_rangeTime Frame:
    From study start to 7 years post last dose of Radium-223
    enhanced_encryption
    Safety Issue:
    Yes
  • Incidence of treatment-emergent SAEs
    date_rangeTime Frame:
    From study start up to 30 days after the last administration of Radium-223
    enhanced_encryption
    Safety Issue:
    Yes
  • Incidence of drug-related treatment-emergent adverse events
    date_rangeTime Frame:
    From study start up to 30 days after the last administration of Radium-223
    enhanced_encryption
    Safety Issue:
    Yes
  • Incidence of drug-related SAEs
    date_rangeTime Frame:
    From study start to 7 years post last dose of Radium-223
    enhanced_encryption
    Safety Issue:
    Yes
  • Bone marrow suppression
    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.
    date_rangeTime Frame:
    From study start to 6 months post last dose of Radium-223
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Overall survival
    date_rangeTime Frame:
    From study start to 7 years post last dose of Radium-223
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    From study start to 6 months post last dose of Radium-223
    enhanced_encryption
    Safety Issue:
    No
  • Incidence of bone fractures
    date_rangeTime Frame:
    From study start to 7 years post last dose of Radium-223
  • The number of bone associated events
    e.g. osteoporosis
    date_rangeTime Frame:
    From study start 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 and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.​Click here for access to information about Bayer’s transparency standards and Bayer studies.