Standard dose versus higher and extended dose of Radium 223 in CRPC.
Research type
Research Study
Full title
A three arm randomized, open-label Phase II study of radium-223 dichloride 50 kBq/kg versus 80 kBq/kg, and versus 50 kBq/kg in an extended dosing schedule in subjects with castration-resistant prostate cancer metastatic to the bone
IRAS ID
146245
Contact name
Isabel Syndikus
Contact email
Sponsor organisation
Bayer HealthCare AG
Eudract number
2013-003118-42
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.
Bone metastases are the main cause of disability and death in patients with castration-resistant prostate cancer (CRPC). Given the reality that more than 90% of patients with CRPC develop bone metastases, and the well known subsequent impact on quality of life as well as survival, an agent that specifically targets the major complications of bone metastasis, provides a survival benefit, and has a good safety profile would represent a relevant treatment option and a major therapeutic advance.
Radium-223 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. Radium-223 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.
The goal of this study is to find out whether it is safe to use higher dose of radium223 dichloride for 6 injections or up to 12 standard doses rather than 6 doses (primary end point). We also want to find out whether the prostate cancer is better controlled, further cancer therapy delayed and/or the quality of life and survival improved with a higher dosing regimen.
During the treatment phase, all participants will receive treatment with a Radium-223 dichloride. Participants will be randomised to receive the study drug, as an injection once every 4 weeks, for up to 6 injections at the approved or higher dose level or the approved dose for up to 12 doses. Following this, participants will enter the follow-up phase for up to 7 years.
The study is being sponsored by Bayer HealthCare AG. The study will be run in many countries worldwide, and at approximately 5 hospitals in the UK.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
14/NW/0020
Date of REC Opinion
6 Mar 2014
REC opinion
Further Information Favourable Opinion