- Subjects with histological or cytologically proven prostate cancer with evidence of bone metastases on bone scans or CT / MRI after prior chemotherapy with e.g. taxane or mitoxantrone Patients should have undergone bilateral orchiectomy or should be on continuous androgen deprivation therapy with a gonadotropin releasing hormone agonist or antagonist and should have stopped any anti-androgen therapy for at least 4 weeks before inclusion in the study. Patients should be either on stable (i.e., since at least 3 months) ongoing therapy with a bisphosphonate or without any bisphosphonate therapy. Initiation of a bisphosphonate therapy within this time period prior the study or during the study is not allowed. Total serum testosterone should be less than 50 ng/dL or 1.7 nmol/L.