Radium-223 alpha Emitter Agent in Safety Study in metastatic Castration Resistant Prostate Cancer (mCRPC) population for long-teRm Evaluation

Study Objective:

• To assess the incidence of developing second primary malignancies (including myelodysplatic syndrome (MDS)/acute myeloid leukemia (AML) and osteosarcoma) in mCRPC patients treated with Radium-223 in the routine clinical practice setting.
• To assess the incidence of treatment-emergent serious adverse events (SAEs) (collected up to 30 days after last administration), drug-related adverse events (AEs) collected up to 30 days after last administration), drug-related SAEs (up to 7 years after the last       administration of Radium-223).
• To assess bone marrow suppression.

Participation conditions

Inclusion criteria:

• The treatment decision to Radium-223 needs to be made independent from and before patient enrollment in the study
• Patients with histologically or cytologically confirmed castration resistant adenocarcinoma of the prostate with bone metastases.
• Signed informed consent.

Exclusion criteria:

• Patients previously treated with Radium-223 for any reason.
• Patients currently treated in clinical trials including other Radium-223 studies
• Patients are planned for the systemic concomitant use of other radiopharmaceuticals for treatment of prostate cancer or for other use

Centre Hospitalier de Luxembourg (CHL)