Radium 223 in Castrate Resistant Prostate Cancer Bone Metastases

Inclusion Criteria

• Histologically proven adenocarcinoma of the prostate with evidence for skeletal metastases on bone scan and/or CT scan and symptoms judged to be related to bone metastases
• Eastern Cooperative Oncology Group (ECOG) performance status /= 50%)
• Serum testosterone levels 4 weeks prior to study drug. Steroids chronically prescribed for a non-cancer-related illness [e.g. asthma or chronic obstructive pulmonary disease (COPD)] that is well controlled with medical management are permissible to an equivalent of 3,000/ul; b.) Absolute Neutrophil Count (ANC) > 1,500/ul; c.) Hemoglobin >/= 8.0 g/dL independent of transfusion; d.) Platelet count >/= 100,000/uL; e.) Serum albumin >/= 3.0 g/dL; f.) Calculated or measured creatinine clearance > 30 mL/min
• All acute toxic effects of any prior treatment have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0 Grade 1 or less at the time of signing the Informed Consent Form (ICF)
• Patient must be willing and able to comply with protocol requirements. All patients must sign an informed consent indicating that they are aware of the investigational nature of this study
• Patients must also have signed an authorization for the release of their protected health information

Exclusion Criteria

• Treatment with cytotoxic chemotherapy within previous 4 weeks of protocol treatment, or failure to recover from AEs due to cytotoxic chemotherapy administered more than 4 weeks prior to protocol treatment (however, ongoing neuropathy is permitted)
• Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or Ra-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)
• Known 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 spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Treatment should be completed for spinal cord compression
• Any other serious illness or medical condition, such as but not limited to: a) Any infection >/= National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 Grade 2; b) Cardiac failure New York Heart Association (NYHA) III or IV; c) Crohn's disease or ulcerative colitis; d) Bone marrow dysplasia; e) Fecal incontinence
• Inability to comply with the protocol and/or not willing or not available for follow-up assessments
• Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation
• Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than Ra 223 dichloride
• Prior use of Ra-223 dichloride, Strontium or Samarium
• Concurrent use of another investigational drug or device therapy (i.e., outside of study treatment) during, or within 4 weeks of trial entry (signing of the informed consent form)
• Major surgery within 30 days prior to start of study drug