REASSURE: Radium-223 post authorisation safety study
Research type
Research Study
Full title
REASSURE - Radium-223 alpha emitter agent in safety study in mCRPC population for long-term evaluation
IRAS ID
159366
Contact name
Sian Wilson
Contact email
Sponsor organisation
Bayer Plc
Research summary
Summary of Research
Prostate cancer is the most common form of non-skin cancer in men and can spread actively and aggresively to other parts of the body (metastases). The most common site for the cancer to spread to (in advanced prostate cancer) is the skeleton. Approximately 50% of patients with bone cancer (spead from prostate cancer) die of prostate cancer within 30 months, and 80% within 5 years.
Prostate cancer cells are stimulated by hormones, in particular testosterone. Conventional androgen deprivation therapy (ADT) in patients with bone cancer aims to reach castration levels of testosterone which can be initially effective at controlling the cancer in the bone. However, the majority of patients soon become castration resistant, i.e. progression occurs even at castration levels of testosterone. At this stage, the disease can interchangeably be referred to as either CRPC (castration resistant prostate cancer) or the older term hormone-refractory prostate cancer (HRPC).
This observational study called REASSURE is to assess the incidence of second cancers among patients with metastatic Castration Resistant Prostate Cancer (mCRPC) receiving Radium-223 in routine clinical practice (i.e. cancer progression). The short and long term safety profile of Radium-223, which selectively targets bone cancer with high-energy, short-range alpha-particles will also be evaluated. In addition bone marrow suppression, overall survival and pain-related data will be collected.
Summary of Results
Lay summary of study results: The study provides a robust dataset which demonstrates a
low incidence of Second primary malignancies and observation of manageable treatment-emergent adverse events. Generalizability is supported by the diverse patient population across multiple countries, reflecting real-world clinical settings. Therefore, the study confirms that radium‑223 maintains a favorable benefit-risk profile in treatment of metastatic castration resistant prostate cancer, reinforcing its role as therapeutic option for patients with bone metastases. No immediate further evidence is deemed necessary to confirm the safety profile. The results do not warrant changes to the known benefit-risk of radium-223 in the authorized indication.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
14/EE/1161
Date of REC Opinion
16 Sep 2014
REC opinion
Favourable Opinion