Radium Ra 223 Dichloride in Treating Patients with Metastatic Castration-Resistant Prostate Cancer

Inclusion Criteria

• Histologically or cytologically confirmed adenocarcinoma of the prostate
• Life expectancy of at least 6 months
• Eastern Cooperative Oncology Group (ECOG) performance status of zero, one, or two
• Bone-predominant metastatic castration resistant prostate cancer (CRPC): at least two skeletal metastases on bone scan with no lung, liver, and/or brain metastasis (lymph node metastasis is allowed)
• Judged by investigator to have progressive disease sufficient to clinically justify standard-of-care radium-223 treatment
• Subjects must be able to understand and be willing to sign the written informed consent form
• All acute toxic effects of any prior treatment have resolved to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 4.0 grade 1 or less at the time of signing the informed consent form (ICF)
• No intention to use cytotoxic chemotherapy within the next 6 months
• Subjects must agree to use adequate contraception beginning at the signing of the ICF until at least 6 months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator
• White blood cell count (WBC) >= 3,000/mm^3
• Absolute neutrophil count (ANC) >= 1,500/mm^3
• Platelet (PLT) count >= 100,000/mm^3
• Hemoglobin (HGB) >= 9 g/dl (please note: it is acceptable from the standpoint of study eligibility to undergo transfusion in order to achieve hemoglobin >= 9 g/dl)
• Total bilirubin level =< 1.5 x institutional upper limit of normal (ULN)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN
• Creatinine =< 2 x ULN
• Albumin > 25 g/L
• Willing and able to comply with the protocol, including follow-up visits and examinations

Exclusion Criteria

• Treatment with cytotoxic chemotherapy within previous 28 days, or failure to recover from adverse events (AEs) due to cytotoxic chemotherapy administered more than 28 days previous (however, ongoing neuropathy is permitted)
• Received any investigational compound within 28 days prior to the first dose of study drug or planned during the treatment period or follow-up
• Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or radium Ra 223 dichloride) for the treatment of bony metastases
• Received previous radiotherapy to approximately > 25% of bone marrow
• 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
• 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 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: * 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 * Known bone marrow dysplasia
• Fecal incontinence
• Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation