Radium-223 in subjects with bone predominant metastatic CRPC.
Research type
Research Study
Full title
A phase III randomized, double-blind, placebo-controlled trial of radium-223 dichloride in combination with abiraterone acetate and prednisone/prednisolone in the treatment of asymptomatic or mildly symptomatic chemotherapy-naïve subjects with bone predominant metastatic castration-resistant prostate cancer (CRPC)
IRAS ID
129217
Contact name
Chris Parker
Contact email
Sponsor organisation
Bayer AG
Eudract number
2013-003438-33
Duration of Study in the UK
7 years, 6 months, 0 days
Research summary
Prostate cancer has become an increasingly important health issue globally. Prostate cancer is the fifth most common tumour type worldwide, with 679,060 men diagnosed each year, and is one of the leading cause of cancer related morbidity and death.
The treatment options for patients with prostate cancer which has spread to bones are still limited. One of the standard treatments for this type of prostate cancer is abiraterone and prednisone or prednisolone.
The purpose of this study is to understand if adding radium 223 to abiraterone and prednisone or prednisolone helps men to survive longer with a delay in the occurrence of skeletal events related to prostate cancer metastasis.
Radium223 dichloride is radiopharmaceutical (radioactive drug) that is being investigated as a treatment for patients with prostate cancer that has spread to the bones. It is given by injection into a vein in the arm. Radium223 is similar to calcium and because of this it is taken up into the bones. It works by giving off radioactivity which kills the tumour cells that have spread to the bone.
During the treatment phase, all participants will receive treatment with abiraterone and prednisone/prednisolone. In addition participants will be randomised to receive either, Radium223 (the active study drug) or placebo (a dummy medicine). They will receive the study drug or placebo as an injection once every 4 weeks, for up to 6 injections. Following this, participants will visit the study site, or if no longer can travel to the site they will be contacted by phone once every 12 weeks during active follow up period. When thay have completed the Active Follow-Up period, they will be contacted over the phone every 6 months for a long term follow up visits until the study ends.
The study is being sponsored by Bayer HealthCare AG. The study will be run in many countries worldwide, and at approximately 8 hospitals in the UK.
REC name
London - Fulham Research Ethics Committee
REC reference
14/LO/0135
Date of REC Opinion
19 Mar 2014
REC opinion
Further Information Favourable Opinion