Validation of the Prostate Cancer Assay - Beta+Pivotal

Inclusion Criteria:

* • Male aged 18 years and above

  * Be willing to sign an informed consent document indicating that the subject understands the purpose of and procedures required for the study and are willing to participate in the study
  * Be willing/able to adhere to the prohibitions and restrictions specified in this protocol
  * Eastern cooperative group (ECOG) performance status ≤2
  * Documented histologically confirmed adenocarcinoma of the prostate
  * Metastatic prostate cancer to the bone as documented by positive bone scan imaging
  * CRPC patient being considered for systemic therapy or in between lines of therapies (\>= 14 days from prior treatment) for metastatic disease. Patient must have evidence of castrate resistant prostate cancer as evidenced by a confirmed rising PSA (per Prostate Cancer Working Group 2 \[PCWG2\] criteria) and a castrate serum testosterone level (i.e. ≤ 50 mg/dl).

Exclusion Criteria:

* • Subjects actively receiving systemic therapy regimens, or between lines of therapies (\< 14 days from prior treatment)

  * Have any condition that, in the opinion of the investigator, would compromise the wellbeing of the subject or the study or prevent the subject from meeting or performing study requirements
  * Active infection or other medical condition that would make corticosteroids (i.e. prednisone) use contraindicated
  * Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg) Patients with a history of hypertension are allowed provided blood pressure is controlled by antihypertensive treatment
  * Severe hepatic impairment (Child-Pugh Class C)
  * History of pituitary or adrenal dysfunction (note: the use of daily steroids does not exclude someone from participating in this study)
  * Have poorly controlled diabetes (HgB A1C ≥ 8%)
  * Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.
  * Abnormal bone marrow function (absolute neutrophil count \[ANC\] \< 1500/mm3, platelet count \<100,000/mm3, hemoglobin \<9 g/dL)
  * Abnormal liver function (bilirubin \> upper limit of normal \[ULN\]; AST and/or ALT \> 1.5 x ULN concomitant with alkaline phosphatase \> 2.5 x ULN)
  * Abnormal kidney function (serum creatinine ≥ 2 x upper limit of normal)
  * Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, unstable atrial fibrillation, or New York Heart Association (NYHA) Class III-IV heart disease
  * History of ventricular tachyarrhythmia within the past 5 years