Denosumab Prostate Cancer Extension Study to Prevent Bone Metastasis

• Research type

  Research Study

• Full title

  An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab for Prolonging Bone Metastasis-Free Survival in Men with Hormone Refractory Prostate Cancer

• IRAS ID

  60802

• Contact name

  Robert Coleman

• Sponsor organisation

  Amgen Inc.

• Eudract number

  2010-021846-23

• ISRCTN Number

  N/A

• Research summary

  The purpose of this extension study is to collect long-term information about denosumab, and to provide an opportunity for study participants from the protocol number 20050147 (06/MRE03/14) who are continuing on every 4 week study visits to receive denosumab for up to 3 more years. This extension study is dependent on a positive outcome from the 20050147 study whereby Denosumab is shown to be better than a placebo in delaying the prevention of bone metastasis in patients with hormone-refractory prostate cancer. The results of the 20050147 study are expected to be announced in December 2010, and if the result is positive the continuing UK study participants will be invited to take part in this extension study within 1 month. Patients who agree to participate in this study will receive a single injection of open-label denosumab under the skin every 4 weeks for a maximum of 3 years (36 months) from the start of this study.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  10/H0408/87

• Date of REC Opinion

  24 Nov 2010

• REC opinion

  Further Information Favourable Opinion