A Phase 4, Randomized, Open-label, Multicenter Efficacy and Safety Study of Standard Dose of Radium-223 Dichloride vs. Standard Doses of Novel Anti-hormonal Therapy (NAH) in Patients With Bone Dominant Metastatic Castration Resistant Prostate Cancer (mCRPC) Progressing on/After One Line of NAH
Researchers in this study want to compare how well drug radium-223 dichloride (Xofigo) and
new (novel) anti-hormonal (NAH) therapy work in participants with prostate gland cancer which
has spread to the bone and progressed on or after one line of NAH therapy. Meanwhile
researchers want to compare the safety of radium-223 dichloride and NAH therapy. Radium-223
dichloride is known as a radioactive drug that is taken up by bones after it is injected into
the body. It works by giving off a type of radioactivity that travels a very short distance
and kills the tumor cells that have spread to the bone without major effects to the healthy
cells. It has been approved in many countries for the treatment of patients with prostate
cancer which has spread to the bone. The NAH drugs used in this study will be either
abiraterone acetate (Zytiga) (plus prednisone/prednisolone) or enzalutamide (Xtandi). Both of
them are standard approved medications which are used in the treatment of advanced prostate
Participants in this study will receive either Radium-223 dichloride or a NAH therapy.
Radium-223 dichloride will be given as an infusion into one of the veins on Day 1 of each
4-week cycle for a total of up to 6 cycles. Oral NAH therapy will be given per the standard
approved dose once daily until the disease has progressed. Participants will visit the
hospital or clinic every 2 weeks for the first 6 cycles, and only on the first day of each
cycle from cycle 7 and onwards. Observation for each participant will last for about 2 years
in total. Blood and urine samples will be collected from the participants and participants
will be asked to complete questionnaires about the well-being and the pain.
Metastatic Castrate Resistant Prostate Cancer (mCRPC)
Radium-223 dichloride (Xofigo, BAY88-8223),
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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