Abiraterone Post Ketoconazole for Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Abiraterone acetate
Intervention description: Abiraterone acetate 1000 mg by mouth per day
Intervention MeSH terms: Abiraterone Acetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Abiraterone acetate

Summary:

      This is a phase II, open label, single center study to evaluate the efficacy of abiraterone
      acetate (CB7630) administered to patients with castrate resistant prostate cancer who have
      experienced disease progression on ketoconazole.

      It is hypothesized that abiraterone will be active in patients who have experienced disease
      progression on ketoconazole
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed adenocarcinoma of the prostate

          -  Prior therapy with ketoconazole for castration resistant prostate cancer. Patients
             should demonstrate evidence of progression (see below definitions) on ketoconazole or
             evidence of grades 3/4 toxicities on ketoconazole.

               1. Ketoconazole must have been administered for >28 days

               2. At least 27 days must elapse since last ketoconazole dose and first dose of
                  abiraterone acetate

          -  No prior therapy with chemotherapy for metastatic prostate cancer

          -  Metastatic disease based on a positive bone scan or objective imaging on CT scan

          -  Ongoing gonadal androgen deprivation therapy with LHRH analogues or orchiectomy.
             Patients, who have not had an orchiectomy, must be maintained on effective LHRH
             analogue therapy for the duration of the trial

          -  Testosterone < 50 ng/dL

          -  Progressive disease after androgen deprivation: PSA evidence for progressive prostate
             cancer consists of a PSA level of at least 2 ng/ml which has risen on at least 2
             successive occasions, at least 2 weeks apart

          -  Patients who are receiving an antiandrogen as part of primary androgen ablation must
             demonstrate disease progression following discontinuation of antiandrogen

          -  ECOG Performance Status 0-1

          -  Age >18 years and able to comply with protocol requirements

          -  Serum Creatinine ≤1.5 x ULN

          -  Serum potassium >3.5mmol/L

          -  Bilirubin ≤1.5x ULN

          -  AST and ALT ≤2.5 x ULN

          -  Life expectancy of >12 weeks

        Exclusion Criteria:

          -  Therapy with other hormonal therapy, including any dose of megestrol acetate (Megace),
             finasteride (Proscar), dutasteride (Avodart) any herbal product known to decrease PSA
             levels (e.g., Saw Palmetto and PC-SPES), or any systemic corticosteroid within 4 weeks
             prior to first dose of study drug

          -  Therapy with supplements or complementary medicines/botanicals within 4 weeks of first
             dose of study drug, except for any combination of the following; conventional
             multivitamin supplements, Selenium, Lycopene and Soy supplements

          -  Prior radiation therapy completed < 4 weeks prior to enrollment

          -  Prior chemotherapy for castration resistant prostate cancer. Patients who have
             received chemotherapy for early stage prostate cancer (e.g. as part of a neoadjuvant
             or adjuvant trial) or for other malignancies are eligible provided that >1 year has
             passed since the administration of the last chemotherapy dose.

          -  Hemoglobin ≤9.0 g/dL

          -  Any "currently active" second malignancy, other than non-melanoma skin cancer Patients
             are not considered to have a "currently active" malignancy, if they have completed
             therapy and are considered by their physician to be at least less than 30% risk of
             relapse over next 3 months

          -  Blood pressure that is not controlled despite >2 oral agents (SBP >160 and DBP >90 on
             three or more readings within the screening period)

          -  Serum K+ <3.5 mmoL/L on more than one reading within the screening period

          -  NYHA Class II, NYHA Class III or IV Congestive Heart Failure

          -  Myocardial infarction within the 6 months prior to the first dose of study drug

          -  Serious intercurrent infections or nonmalignant medical illnesses that are
             uncontrolled

          -  Concurrent therapy with drugs that are metabolized as substrates of CYP1A2, CYP2D6, or
             CYP2C19 and are considered by the investigators to pose a risk for drug to drug
             interactions