Radium(223) Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases

Exclusion Criteria

• •Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period or follow-up
• •Eligible for first course of docetaxel, i.e., patients who are fit enough, willing, and who are located where treatment with docetaxel is available
• •Treatment with cytotoxic chemotherapy within previous 4 weeks, or failure to recover from AEs (adverse events) due to cytotoxic chemotherapy administered more than 4 weeks previous (however, ongoing neuropathy is permitted)
• •Prior hemibody external radiotherapy is excluded. Patients who received other types of prior external radiotherapy are allowed provided that the bone marrow function is assessed and meets the protocol requirements for hemoglobin, absolute neutrophil count and platelets
• •Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or radium-223 dichloride) for the treatment of bony metastases
• •Other malignancy treated within the last 3 years (except non melanoma skin cancer or low-grade superficial bladder cancer)
• •Visceral metastases as assessed by abdominal or pelvic computed tomography (CT) (or other imaging modality based on institutional standard of care)
• •Presence of brain metastases
• •Lymphadenopathy exceeding 6 cm in short-axis diameter
• •Any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis
• •Imminent or history of spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Patients with history of spinal cord compression should have completely recovered.
• •Any other serious illness or medical condition, such as but not limited to:
• •* Any infection ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade 2
• •* Cardiac failure New York Heart Association (NYHA) III or IV
• •* Crohn's disease or ulcerative colitis
• •* Bone marrow dysplasia
• •Fecal incontinence