A Placebo-controlled Phase II Study of Bone-targeted Radium-223 in Symptomatic Hormone-refractory Prostate Cancer

Inclusion Criteria

• •Histologically/cytologically confirmed adenocarcinoma of the prostate
• •Patient has received or is receiving hormonal treatment (orchiectomy, polyoestradiol phosphate, or gonadotropin-releasing hormone analogue with or without antiandrogen)
• •Metastatic disease with positive bone scan within 2 months before treatment with more than one cancer related lesion or with one painful cancer related lesion in the presence of increasing PSA levels as follows: PSA \>5 ng/ml, with increases on at least 2 successive occasions at least 2 weeks apart.
• •Patient is referred to local field radiotherapy (EBR) for metastatic bone pain. The area to be treated (index site) should match the positive bone scan, local radiation area not exceeding 400 cm2
• •ECOG performance status: 0-2
• •Life expectancy: at least 3 months
• •Age more than 40 years
• •Laboratory requirements:
• •* Hematology: Neutrophil count ≥1,5 x 109/L Platelet count at least ≥100 x109/L and stable Hemoglobin \>100 g/l or 10 g/dL
• •* Hepatic function: Bilirubin within normal institutional limits ASAT and ALAT \<2,5 times upper limit of normal (ULN)
• •* Renal function: Creatinine \<1,5 times the ULN (i.e. NCI grade ≤1)
• •Patient is willing and able to comply with the protocol, and agrees to return to the hospital for follow-up visits and examinations
• •Patient has been fully informed about the study and has signed the informed consent form