Phase 2 study of MDV3100 for metastatic prostate cancer

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Phase II Efficacy and Safety Study of MDV3100 (ASP9785) vs. Bicalutamide in Castrate Men with Metastatic Prostate Cancer

• IRAS ID

  68852

• Sponsor organisation

  Astellas Pharma Global Development, INC (APGD)

• Eudract number

  2010-021868-15

• ISRCTN Number

  n/a

• Research summary

  Prostate cancer is the third most common cancer in men worldwide. In most prostate cancers the growth of the cancer cells is activated by the male hormone testosterone. Reduction of testosterone can help to reduce tumour growth and the spread of the cancer. MDV3100 is a new drug that has been found to block the action of testosterone and slow the growth of cancer cells. The purpose of this study is to look at how well MDV3100 works and how safe it is compared to the standard treatment with a drug called bicalutamide. All patients will continue to take their current testosterone lowering treatment as prescribed in addition to the study drug. Half of the patients will be given MDV3100 and a placebo and the other half bicalutamide and a placebo. Study treatment will continue until there are signs of the of disease progression. Patients will be required to visit the clinic initially every 4 weeks and later on in the study every 12 weeks. Approximately 300 patients in North America and Europe will take part in this study.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  11/LO/0608

• Date of REC Opinion

  25 Jul 2011

• REC opinion

  Further Information Favourable Opinion