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

Metastatic Castration-resistant Prostate Cancer Clinical Trial

— REASSURE  

Official title:

Radium-223 Alpha Emitter Agent in Non-intervention Safety Study in mCRPC popUlation for Long-teRm Evaluation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02141438
• Other study ID #: 16913
• Status: Active, not recruiting
• Start date: August 20, 2014
• Est. completion date: October 24, 2024

Study information

• Verified date: June 2024
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1474
• Est. completion date: October 24, 2024
• Est. primary completion date: August 2, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Metastatic Castration-resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  Canada,  Colombia,  Czechia,  Denmark,  France,  Germany,  Greece,  Israel,  Italy,  Luxembourg,  Mexico,  Netherlands,  Portugal,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of developing second primary malignancies		From study start to 7 years post last dose of Radium-223
Primary	Incidence of treatment-emergent SAEs		From study start up to 30 days after the last administration of Radium-223
Primary	Incidence of drug-related treatment-emergent adverse events		From study start up to 30 days after the last administration of Radium-223
Primary	Incidence of drug-related SAEs		From study start to 7 years post last dose of Radium-223
Primary	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.	From study start to 6 months post last dose of Radium-223
Secondary	Overall survival		From study start to 7 years post last dose of Radium-223
Secondary	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
Secondary	Incidence of bone fractures		From study start to 7 years post last dose of Radium-223
Secondary	The number of bone associated events	e.g. osteoporosis	From study start to 7 years post last dose of Radium-223

External Links

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