Observational Study for the Evaluation of Long-term Safety of Radium-223 Used for the Treatment of Metastatic Castration Resistant Prostate Cancer
NCT ID: NCT02141438
Last Updated: 2025-10-16
Study Results
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View full resultsBasic Information
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COMPLETED
1472 participants
OBSERVATIONAL
2014-08-20
2024-10-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Radium-223 dichloride (Xofigo, BAY88-8223)
Single-arm cohort observational study with CRPC patients with bone metastasis treated with Radium-223.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed castration resistant adenocarcinoma of the prostate with bone metastases
* Signed informed consent
Exclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Anchorage, Alaska, United States
Scottsdale, Arizona, United States
Daly City, California, United States
Long Beach, California, United States
Sacramento, California, United States
San Diego, California, United States
Colorado Springs, Colorado, United States
Boca Raton, Florida, United States
Fort Myers, Florida, United States
Jacksonville, Florida, United States
Lakewood Rch, Florida, United States
Plantation, Florida, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Honolulu, Hawaii, United States
Evanston, Illinois, United States
Warrenville, Illinois, United States
Wichita, Kansas, United States
Ashland, Kentucky, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Rockville, Maryland, United States
Towson, Maryland, United States
Boston, Massachusetts, United States
Troy, Michigan, United States
St Louis, Missouri, United States
Billings, Montana, United States
Omaha, Nebraska, United States
Lebanon, New Hampshire, United States
Neptune City, New Jersey, United States
Township, New Jersey, United States
Buffalo, New York, United States
East Setauket, New York, United States
Lake Success, New York, United States
Winston-Salem, North Carolina, United States
Middleburg Heights, Ohio, United States
Oklahoma City, Oklahoma, United States
Springfield, Oregon, United States
Abington, Pennsylvania, United States
Charleston, South Carolina, United States
Myrtle Beach, South Carolina, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Lubbock, Texas, United States
San Antonio, Texas, United States
Temple, Texas, United States
Charlottesville, Virginia, United States
Virginia Beach, Virginia, United States
Seattle, Washington, United States
Multiple Locations, , Argentina
Multiple Locations, , Austria
Multiple Locations, , Belgium
Multiple Locations, , Canada
Multiple Locations, , Colombia
Multiple Locations, , Czechia
Multiple Locations, , Denmark
Multiple Locations, , France
Multiple Locations, , Germany
Multiple Locations, , Greece
Multiple Locations, , Israel
Multiple Locations, , Italy
Multiple Locations, , Luxembourg
Multiple Locations, , Mexico
Multiple Locations, , Netherlands
Multiple Locations, , Portugal
Multiple Locations, , Spain
Multiple Locations, , Sweden
Multiple Locations, , United Kingdom
Countries
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References
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O'Sullivan JM, Heinrich D, Castro E, George S, Dizdarevic S, Baldari S, Essler M, Jong IJ, Lastoria S, Hammerer PG, Tombal B, James ND, Meltzer J, Sandstrom P, Sartor O. Alkaline phosphatase decline and pain response as predictors of overall survival benefit in patients treated with radium-223: a post hoc analysis of the REASSURE study. Br J Cancer. 2025 Mar;132(4):354-360. doi: 10.1038/s41416-024-02927-w. Epub 2025 Jan 9.
Higano CS, Dizdarevic S, Logue J, Richardson T, George S, de Jong I, Tomaszewski JJ, Saad F, Miller K, Meltzer J, Sandstrom P, Verholen F, Tombal B, Sartor O. Safety and effectiveness of the radium-223-taxane treatment sequence in patients with metastatic castration-resistant prostate cancer in a global observational study (REASSURE). Cancer. 2024 Jun 1;130(11):1930-1939. doi: 10.1002/cncr.35221. Epub 2024 Feb 10.
Sartor O, Fougere C, Essler M, Ezziddin S, Kramer G, Ellinger J, Nordquist L, Sylvester J, Paganelli G, Peer A, Bogemann M, Meltzer J, Sandstrom P, Verholen F, Song DY. 177Lu-Prostate-Specific Membrane Antigen Ligand After 223Ra Treatment in Men with Bone-Metastatic Castration-Resistant Prostate Cancer: Real-World Clinical Experience. J Nucl Med. 2022 Mar;63(3):410-414. doi: 10.2967/jnumed.121.262240. Epub 2021 Jun 24.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Click here for access to information about Bayer's transparency standards and Bayer studies.
Other Identifiers
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16913
Identifier Type: -
Identifier Source: org_study_id
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