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

Completed

• Conditions: Metastatic Castration-resistant Prostate Cancer
• Interventions: Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

• Registration Number: NCT02141438
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-15
• Study First Submitted QC: 2014-05-15
• Study First Posted: 2014-05-19
• Study Start: 2014-08-20
• Primary Completion: 2024-08-02
• Study Completion: 2024-10-24
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1474

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Radium-223 dichloride (Xofigo, BAY88-8223)	Radium-223 dichloride (Xofigo, BAY88-8223)	Single-arm cohort observational study with CRPC patients with bone metastasis treated with Radium-223.

Primary Outcome Measures

Name	Time	Method
Incidence of developing second primary malignancies	From study start to 7 years post last dose of Radium-223
Incidence of treatment-emergent SAEs	From study start up to 30 days after the last administration of Radium-223
Bone marrow suppression	From study start to 6 months post last dose of Radium-223	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.
Incidence of drug-related treatment-emergent adverse events	From study start up to 30 days after the last administration of Radium-223
Incidence of drug-related SAEs	From study start to 7 years post last dose of Radium-223

Secondary Outcome Measures

Name	Time	Method
Overall survival	From study start to 7 years post last dose of Radium-223
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	From study start to 6 months post last dose of Radium-223
Incidence of bone fractures	From study start to 7 years post last dose of Radium-223
The number of bone associated events	From study start to 7 years post last dose of Radium-223	e.g. osteoporosis