Retreatment safety study of radium-223 dichloride in prostate cancer
Research type
Research Study
Full title
A re-treatment safety study of radium-223 dichloride in subjects with castration-resistant prostate cancer with bone metastases who received an initial course of six doses of radium-223 dichloride 50 kBq/kg every four weeks
IRAS ID
147733
Contact name
Santhanam Sundar
Contact email
Sponsor organisation
Bayer HealthCare AG
Eudract number
2013-003046-17
Clinicaltrials.gov Identifier
Research summary
Radium-223 dichloride is a radiopharmaceutical (radioactive drug) that is being investigated for the re-treatment of patients with prostate cancer that has spread to the bones. It is given by injection into a vein in the arm. Radium-223 dichloride is mainly taken up into bones after it is injected. It works by giving off radioactivity which kills prostate cancer cells that have spread to bones. The type of radiation given off (alpha particles) has a very short range (just a fraction of a millimetre) and therefore radium-223 dichloride only affects tumour cells in the bone that has taken it up.
The approved way of administering radium-223 is one dose every 4 weeks for a maximum of 6 doses. However, after the 6th dose, the prostate cancer in bones eventually worsens, and may cause pain and other complications.
The purpose of this study is to explore the safety of re-treating patients whose prostate cancer worsened after 6 doses of radium-223 dichloride, with another 6 doses, once every 4 weeks. During the treatment phase, patients will visit the study site at least every 4 weeks for treatment and assessments. Assessments will include blood tests, physical examinations, assessment of pain, full body bone scans, x-rays, and MRI or CT scans.
After the end of study treatment, the patients will enter a follow up period and continue to be evaluated for up to 2 years after their last dose of radium-223 dichloride. After this, patients will enter a long-term follow-up period and will be phoned every 6 months for up to 7 years after their last dose of radium-223 dichloride.
The study is sponsored by Bayer HealthCare. The study will be run in several countries worldwide, and at approximately 2 hospitals in the UK. 40 patients will take part in the study globally.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
14/WM/0063
Date of REC Opinion
3 Mar 2014
REC opinion
Favourable Opinion