IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen
Condition: Prostate Cancer; Prostatic Neoplasm
MeSH terms: Prostatic Neoplasms
Intervention: abiraterone acetate in combination with prednisone
Intervention description: Abiraterone acetate will be taken as 4 x 250 mg tablets by mouth (PO) once daily. Prednisone will be taken as 2 x 2.5 mg tablets PO once daily.
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: 131.0
Sex: Male
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: abiraterone acetate; prednisone; zytiga

Summary:

      The purpose of this study is to show that abiraterone acetate plus prednisone added to the
      current standard of care, gonadotropin-releasing hormone (GnRH) decreases prostate specific
      antigen (PSA) and prolongs the time until it is evident that the cancer has grown.
      Additionally, safety information about abiraterone acetate in combination with prednisone
      will be collected. This will include looking at what side effects occur, how often they
      occur, and for how long they last.
    

Eligibility criteria:

        Major Inclusion Criteria:

          -  Be a male >= 18 years of age

          -  Have adenocarcinoma of the prostate

          -  Currently receiving continuous treatment with Gonadotropin-releasing hormone (GnRH)
             monotherapy for at least 6 months before or have undergone surgical removal of the
             testicles

          -  Serum testosterone of < 50 ng/dL(< 2.0 nM)

          -  Have rising PSA defined as a PSA of >= 10 ng/mL obtained at screening or PSADT of ≤ 10
             months with the first of the 3 consecutive PSA values used to calculate PSADT ≥ 2.0
             ng/mL

          -  Have an Eastern Cooperative Oncology Group (ECOG) performance status less than or
             equal to 2

          -  Be capable of swallowing study agents whole as a tablet

          -  Be willing/able to adhere to the prohibitions and restrictions specified in this
             protocol

        Major Exclusion Criteria:

          -  Have prior or current evidence of local disease progression or metastatic disease as
             defined by modified response evaluation criteria in solid tumors (RECIST) criteria

          -  Have received chemotherapy for treatment of castrate-resistant prostate cancer;
             however, if a patient received chemotherapy in an adjuvant setting, prior to having
             CRPC, for castrate-sensitive prostate cancer, the patient is still eligible

          -  Are currently receiving any antiandrogen therapy (eg, bicalutamide, flutamide, or
             nilutamide).

          -  If previously treated with antiandrogen therapy, there must be documentation of at
             least 2 consecutive rising PSA values at least 2 weeks apart obtained prior to
             screening

          -  If previously treated with flutamide, at least 1 of the PSA values must be obtained 4
             weeks or more after flutamide discontinuation.

          -  If previously treated with bicalutamide or nilutamide, at least 1 of the PSA values
             must be obtained 6 weeks or more after antiandrogen discontinuation

          -  Have previously received agents having any CYP17 inhibitory activity for the treatment
             of prostate cancer, such as ketoconazole

          -  Have previously received aminoglutethimide

          -  Have an active infection or other medical condition that would contraindicate
             prednisone use

          -  Have uncontrolled hypertension

          -  Have active hepatitis or chronic liver disease

          -  Have clinically significant heart disease

          -  Have poorly controlled diabetes

          -  Have received an investigational therapeutic within 30 days of screening

          -  Have partners of childbearing potential and are not 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.

          -  Individuals with a history of a non-prostate malignancy are ineligible for this study
             with the following exceptions. Individuals with a history of other malignancies are
             eligible if they have been disease-free for at least 3 years and are deemed by the
             investigator to be at low risk for recurrence of that malignancy. Individuals with the
             following cancers are eligible if diagnosed and treated within the past 3 years: basal
             cell or squamous cell carcinoma of the skin