A Biomarker Study of Standard-of-care Radium-223 Chloride for Metastatic Castration-resistant Prostate Cancer

Inclusion Criteria

• •Male age ≥ 18 years.
• •Histologically or cytologically confirmed adenocarcinoma of the prostate. Life expectancy of at least 6 months.
• •ECOG performance status of zero, one, or two.
• •Bone-predominant metastatic CRPC: at least two skeletal metastases on bone scan with no lung, liver, and/or brain metastasis (lymph node metastasis is allowed).
• •Symptomatic as defined by either of the following:
• •* (a) Regular use of analgesic medication for cancer-related bone pain (≥ level 1; WHO ladder for cancer pain), or
• •* (b) Treatment with EBRT for bone pain (though EBRT must be completed ≥12 weeks prior to enrollment in this trial).
• •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 NCI-CTCAE v4.0 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.
• •Acceptable hematology and serum biochemistry screening values:
• •* White Blood Cell Count (WBC) ≥ 3,000/mm3
• •* Absolute Neutrophil Count (ANC) ≥ 1,500/mm3
• •* Platelet (PLT) count ≥ 100,000/mm3
• •* Hemoglobin (HGB) ≥10 g/dl (Please note: it is acceptable from the standpoint of study eligibility to undergo transfusion in order to achieve hemoglobin ≥ 10 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 ≤ 1.5 x ULN
• •* Albumin \> 25 g/L
• •Willing and able to comply with the protocol, including follow-up visits and examinations.