A Study to Evaluate Serum Testosterone Levels in Patients With Metastatic Castration-Resistant Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Zytiga® (Abiraterone Acetate); SoluMatrix™ (Abiraterone Acetate)
Intervention description: Zytiga® 1,000 mg (4 x 250 mg qd) tablets plus one 5 mg prednisone tablet to be taken bid, spaced approximately 12 hours apart; SoluMatrix™ 500 mg (4 x 125 mg qd) tablets plus one 4 mg methylprednisolone tablet bid, spaced approximately 12 hours apart
Intervention MeSH terms: Abiraterone Acetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the serum testosterone levels in patients with
      Metastatic Castration-Resistant Prostate Cancer on SoluMatrix™ Abiraterone Acetate as
      Compared to Abiraterone Acetate
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written informed consent obtained prior to any study-related procedure being performed

          2. Male subjects at least 18 years of age or older at time of consent

          3. Pathologically confirmed adenocarcinoma of the prostate

          4. Ongoing therapy with a GnRH agonist or antagonist AND serum testosterone level <50
             ng/dL at screening

          5. Metastatic disease documented by computed tomography (CT)/ magnetic resonance imaging
             (MRI) or bone scan. Imaging obtained within 42 days prior to the start of study
             medication will be accepted.

          6. Meeting disease progression according to the recommendations of the prostate cancer
             working group 2 by one of the following criteria:

               -  Two rises of PSA (taken a minimum of 1 week apart) from a baseline measurement of
                  at least 2 ng/mL,

               -  Imaging progression (CT/MRI) by RECIST criteria

               -  Nuclear scan progression by new lesion.

          7. Discontinuation of flutamide or nilutamide, and other anti-androgens at least 4 weeks
             prior to the start of study medication; discontinuation of bicalutamide at least 6
             weeks prior to start of study medication.

          8. Discontinuation of Radiotherapy > 4 weeks prior to start of study medication.

          9. ECOG performance status of 0-1 at screening

         10. Screening blood counts of the following:

               -  Absolute neutrophil count > 1500/µL

               -  Platelets > 100,000/µL

               -  Hemoglobin > 9 g/dL

         11. Screening chemistry values of the following:

               -  ALT and AST < 2.5 x ULN

               -  Total bilirubin < 1.5 x ULN

               -  Creatinine< 1.5 x ULN

               -  Albumin > 3.0 g/dL

         12. Potassium > 3.5 mmol/L

         13. Life expectancy of at least 6 months at screening

         14. Subject is willing and able to comply with all protocol requirements assessments

         15. Agrees to protocol-defined use of effective contraception.

        Exclusion Criteria:

          1. History of impaired pituitary or adrenal gland function

          2. Prior therapy with abiraterone acetate, orteronel, ketoconazole or any other CYP17
             inhibitor

          3. Prior therapy with enzalutamide

          4. Prior use of experimental androgen receptor antagonist

          5. Previous exposure to Ra-223:Xofigo

          6. Previous chemotherapy

          7. Initiation of bisphosphonate or denosumab therapy within 30 days prior to the start of
             study medication. Patients who are on a stable dose of these medications for at least
             30 days at the time of starting study drug are eligible.

          8. Therapy with estrogen within 30 days prior to the start of study medication

          9. Use of systemic glucocorticoids equivalent to > 10 mg of prednisone daily; patients
             who have discontinued or have reduced dose to < 10 mg prednisone within 14 days prior
             to the start of study medication will be eligible

         10. Prior use of any herbal products that may decrease PSA levels (eg., saw palmetto)
             within 30 days of start of study medication

         11. Known metastases to the brain or CNS involvement

         12. History of other malignancy within the previous 2 years

         13. Major surgery within 30 days prior to the start of study medication

         14. Blood transfusion within 30 days of screening

         15. Serious, persistent infection within 14 days of the start of study medication

         16. Persistent pain that requires the use of a narcotic analgesic

         17. Known gastrointestinal disease or condition that may impair absorption

         18. Treatment with any investigational drug within 4 weeks prior to Day -1 of the study.

         19. Known history of human immunodeficiency virus (HIV) or seropositive test for hepatitis
             C virus or hepatitis B virus

         20. Have poorly controlled diabetes.

         21. Uncontrolled hypertension

         22. History of New York Heart Association (NYHA) class III or IV heart failure

         23. Serious concurrent illness, including psychiatric illness, that would interfere with
             study participation

         24. Inability to swallow tablets whole

         25. Known hypersensitivity to any excipients in study medications

         26. Moderate to severe hepatic impairment (Child-Pugh Classes B and C)