| Trial name or title | A double‐blind, dose‐response phase II, multicentre study of Radium‐223 (Alpharadin TM) for the palliation of painful bone metastases in hormone refractory prostate cancer patients. |
| Methods | Randomised, double blind (subject, investigator), parallel assignment, safety/efficacy study. |
| Participants | Men with prostate cancer and bone metastases that no longer respond to hormonal treatment. |
| Interventions | Alpharadin (radium‐223) at different dose levels, 5, 25, 50 or 100 kBq/kg body weight. |
| Outcomes | Primary outcome measures: pain assessment, analgesic consumption. Secondary outcome measures: reduction of pain, duration of pain relief, time to pain progression, safety of radium‐223, date of death. |
| Starting date | Study start date: May 2005. Estimated study completion date: December 2010. |
| Contact information | Principal investigator: Sten Nilsson. Radiumhemmet, Karolinska University Hospital, 171 76 Stockholm, Sweden. |
| Notes | Identified through www.controlled‐trials.com, accessed on 3/12/8. |
kBq: kiloBecquerel