Radium-223 dichloride in the treatment of CRPC/HRPC patients with bone

• Research type

  Research Study

• Full title

  Radium-223 dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients with Bone Metastasis

• IRAS ID

  101162

• Contact name

  Christopher Parker

• Sponsor organisation

  Bayer HealthCare AG

• Eudract number

  2012-000075-16

• Research summary

  Radium-223 chloride 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 type of radiation given off (alpha-particles) has a very short range (just a fraction of a millimetre) and therefore radium-223 chloride only acts on the tumour cells that are very close to the bone that has taken it up. The purpose of this study is to provide radium-223 chloride to patients with prostate cancer that has spread to the bones and who are not eligible for docetaxel treatment or have progressed after docetaxel treatment. The study will also collect short term and long term safety data. During the treatment phase, participants will receive the study drug as an injection once every 4 weeks, for up to 6 injections. Following this, participants will visit the study site once every 6 months for follow up visits until the study ends. During the study, participants will have blood tests and general checks on their health and pain levels. There is no set number of patients to be enrolled in the study. Patients will be enrolled according to demand for the treatment. All patients participating in the trial will receive study drug. There are no placebos (dummy drug) being used in this trial. The study is being sponsored by Bayer HealthCare. The study will be run in many countries worldwide, and at approximately 28 hospitals in the UK.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  12/SW/0166

• Date of REC Opinion

  1 Jun 2012

• REC opinion

  Favourable Opinion