An Open-label extension (OLE), expanded access study, to assess long-term safety of SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) with Methylprednisolone (4mg bid) in patients who completed study number CHL-AA-201.

An Open-label extension (OLE), expanded access study, to assess long-term safety of SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) with Methylprednisolone (4mg bid) in patients who completed study number CHL-AA-201. An exploratory endpoint of Improved safety from switching from Zytiga (aberaterone Acetate 1000mg(4 x 250 mg qd) to SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) will also be ascertained..

Inclusion Criteria:

1. Written informed consent obtained prior to any study-related procedure being performed
2. Previous, uninterrupted enrollment and treatment in trial number CHL-AA-201.

Exclusion Criteria:

1. Progressive disease as ascertained by the investigator using standard-of-care evaluations.

2. CHL-AA-201 D84 blood counts of the following:

   1. Absolute neutrophil count > 1500/µL
   2. Platelets > 100,000/µL
   3. Hemoglobin > 9 g/dL

3. CHL-AA-201 D84 chemistry values of the following:

   1. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x Upper Limit of Normal (ULN)
   2. Total bilirubin < 1.5 x ULN
   3. Creatinine< 1.5 x ULN
   4. Albumin > 3.0 g/dL
   5. Potassium > 3.5 mmol/L

Peer reviewed Journal and/or professional meeting.