Abiraterone Race in Metastatic Castrate-resistant Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Abiraterone acetate; Prednisone
Intervention MeSH terms: Prednisone; Abiraterone Acetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate cancer; metastatic; castrate resistant; abiraterone acetate; prednisone; metastatic prostate cancer

Summary:

      The primary goal is to prospectively estimate the median radiographic PFS of African American
      and Caucasian men with mCRPC to abiraterone acetate and prednisone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male, age ≥ 18 years

          -  Karnofsky performance status ≥ 70

          -  Life expectancy of ≥ 12 months

          -  Willing to take abiraterone acetate on an empty stomach; no food should be consumed at
             least two hours before and for at least one hour after the dose of abiraterone acetate
             is taken, and should be able to swallow tablets whole, without crushing/chewing
             tablets

          -  Patients who have partners of childbearing potential must be willing to use a method
             of birth control with adequate barrier protection as determined to be acceptable by
             the principal investigator and sponsor during the study and for 1 week after last dose
             of abiraterone acetate

          -  Adequate laboratory parameters

          -  Histologically confirmed diagnosis of adenocarcinoma of the prostate. Histologic
             variants of prostate cancer, including neuroendocrine features and small cell
             carcinoma of the prostate are excluded

          -  Radiographic evidence of metastatic disease; evaluable non-target lesions and/or bone
             only metastasis are permitted

          -  Ongoing ADT using an LHRH agonist (e.g. leuprolide, goserelin) or antagonist (e.g.
             degarelix) must continue on therapy unless prior bilateral orchiectomy has been
             performed. Screening serum testosterone must be <50 ng/dl

          -  PSA ≥ 2.0 ng/mL

          -  Evidence of of castration resistant disease on ADT as evidenced by one of the
             following:

               -  Absolute rise in PSA of 2.0 ng/mL or greater, minimum 2 consecutive rising PSA
                  levels with an interval of ≥ 1 week between each PSA level, OR

               -  2 consecutive PSA levels 50% or greater above the PSA nadir achieved on ADT and
                  separated at least 1 week apart, OR

               -  CT or MRI based evidence of disease progression (soft tissue, nodal or visceral
                  disease progression) according to modified PCWG2 criteria or modified RECIST 1.1
                  criteria, or at least 1 new bone scan lesion as compared to the most immediate
                  prior radiologic studies)

          -  A minimum of 2 weeks elapsed off of antiandrogen therapy prior to start of study drug
             (i.e. flutamide, nilutamide, bicalutamide)

          -  A minimum of 4 weeks elapsed off of sipuleucel-T prior to start of study drug

          -  A minimum of 4 weeks from any major surgery prior to start of study drug

          -  Self-reported race of either African American or Caucasian

          -  Ability to swallow, retain, and absorb oral medication

        Exclusion Criteria:

          -  Prior treatment with abiraterone acetate or enzalutamide

          -  Active infection or other medical condition that would make prednisone/prednisolone
             (corticosteroid) use contraindicated

          -  Any chronic medical condition requiring a higher dose of corticosteroid than 5mg
             prednisone/prednisolone bid

          -  Have known allergies, hypersensitivity, or intolerance to abiraterone acetate or
             prednisone or their excipients

          -  Pathological finding consistent with small cell carcinoma of the prostate

          -  Symptomatic Liver or visceral organ metastasis

          -  Have a history of gastrointestinal disorders (medical disorders or extensive surgery)
             that may interfere with the absorption of the study agents

          -  Known brain metastasis

          -  Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC

          -  Previously treated with ketoconazole for prostate cancer for greater than 7 days

          -  Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole) within 4
             weeks of Cycle 1, Day 1

          -  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
             anti-hypertensive treatment.

          -  Poorly controlled diabetes

          -  Active or symptomatic viral hepatitis or chronic liver disease

          -  History of pituitary or adrenal dysfunction

          -  Clinically significant heart disease as evidenced by myocardial infarction, or
             arterial thrombotic events in the past 6 months, severe or unstable angina, or New
             York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction
             measurement of < 50% at baseline

          -  Atrial Fibrillation or other cardiac arrhythmia requiring therapy

          -  Other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of
             recurrence within 24 months

          -  Administration of an investigational therapeutic within 30 days of Cycle 1, Day 1

          -  Any condition which, in the opinion of the investigator, would preclude participation
             in this trial