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

NCT02141438 | Completed Results

• 1 other identifier: 16913
• Study Type: observational
• Target: 1,472
• Locations: 20 countries
• Sites: 68

Brief Summary

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.

Conditions

Metastatic Castration-resistant Prostate Cancer

Keywords

Radium-223; CRPC; Phase IV; Safety study

Outcome Measures

Primary Outcomes (8)

• 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

  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.

  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.

  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.

  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)

  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

  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

  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.

  From first dose of subsequent chemotherapy up to 6 months (up to 183 days) after the last administration of chemotherapy

Secondary Outcomes (5)

• Overall Survival

  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

  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

  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

  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

  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

Study Arms (1)

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)

Interventions

Radium-223 dichloride (Xofigo, BAY88-8223) DRUG

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.

Radium-223 dichloride (Xofigo, BAY88-8223)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (68)

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Anchorage, Alaska, United States

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Scottsdale, Arizona, United States

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Daly City, California, United States

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Long Beach, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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Colorado Springs, Colorado, United States

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Boca Raton, Florida, United States

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Fort Myers, Florida, United States

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Jacksonville, Florida, United States

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Lakewood Rch, Florida, United States

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Plantation, Florida, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Honolulu, Hawaii, United States

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Evanston, Illinois, United States

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Warrenville, Illinois, United States

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Wichita, Kansas, United States

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Ashland, Kentucky, United States

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New Orleans, Louisiana, United States

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Baltimore, Maryland, United States

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Rockville, Maryland, United States

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Towson, Maryland, United States

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Boston, Massachusetts, United States

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Troy, Michigan, United States

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St Louis, Missouri, United States

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Billings, Montana, United States

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Omaha, Nebraska, United States

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Lebanon, New Hampshire, United States

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Neptune City, New Jersey, United States

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Township, New Jersey, United States

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Buffalo, New York, United States

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East Setauket, New York, United States

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Lake Success, New York, United States

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Winston-Salem, North Carolina, United States

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Middleburg Heights, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Springfield, Oregon, United States

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Abington, Pennsylvania, United States

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Charleston, South Carolina, United States

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Myrtle Beach, South Carolina, United States

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Nashville, Tennessee, United States

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Houston, Texas, United States

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Lubbock, Texas, United States

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San Antonio, Texas, United States

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Temple, Texas, United States

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Charlottesville, Virginia, United States

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Virginia Beach, Virginia, United States

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Seattle, Washington, United States

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Multiple Locations, Argentina

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Multiple Locations, Austria

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Multiple Locations, Belgium

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Multiple Locations, Canada

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Multiple Locations, Colombia

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Multiple Locations, Denmark

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Multiple Locations, France

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Multiple Locations, Greece

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Multiple Locations, Israel

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Multiple Locations, Mexico

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Multiple Locations, Netherlands

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Multiple Locations, Portugal

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Multiple Locations, Spain

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Multiple Locations, Sweden

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Multiple Locations, United Kingdom

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Related Publications (3)

• 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.

  PMID: 39789153 DERIVED

• 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.

  PMID: 38340349 DERIVED

• 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.

  PMID: 34168015 DERIVED

Related Links

• Click here for access to information about Bayer's transparency standards and Bayer studies.

MeSH Terms

Interventions

radium Ra 223 dichloride

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer

clinical-trials-contact@bayer.com

(+) 1-888-8422937

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: May 19, 2014
• Study Start: August 20, 2014
• Primary Completion: August 2, 2024
• Study Completion: October 24, 2024
• Last Updated: October 16, 2025
• Results First Posted: September 5, 2025

Record last verified: 2025-10

Locations

ME (1); ES (1); CZ (1); US (49); AU (1); IL (1); BE (1); SE (1); DK (1); PT (1); GB (1); AR (1); FR (1); GR (1); IT (1); LU (1); NL (1); DE (1); CA (1); CO (1)