Abiraterone With Different Steroid Regimens for Side Effect Related to Mineralcorticoid Excess Prevention in Prostate Cancer Prior to Chemotherapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Abiraterone Acetate; Prednisone 5 mg twice daily; Prednisone 5 mg once daily; Prednisone 2.5 mg twice daily; Dexamethasone 0.5 mg once daily
Intervention description: Type = exact number; unit = mg; number = 1000; form = tablet; route = oral; taken as four 250 mg tablets once daily at least 2 hours after eating and no food should be eaten for at least 1 hour after taking the tablets.; type = exact number; unit = mg; number = 5; form = tablet; route = oral; taken twice daily, the first dose in the morning after a meal and the second dose after a minimum interval of 8 hours in the late afternoon or early evening, after a meal; type = exact number; unit = mg; number = 5; form = tablet; route = oral; taken once daily, in the morning after a meal; type = exact number; unit = mg; number = 2.5; form = tablet; route = oral; taken twice daily, the first dose in the morning after a meal and the second dose after a minimum interval of 8 hours in the late afternoon or early evening, after a meal; type = exact number; unit = mg; number = 0.5; form = tablet; route = oral; taken once daily, in the morning after breakfast
Intervention MeSH terms: Dexamethasone; Prednisone; Abiraterone Acetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 164.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Mineralocorticoid Excess ; Chemotherapy-Naïve; Metastatic Castration-Resistant Prostate Cancer; Abiraterone Acetate; Zytiga; Prednisone; dexamethasone

Summary:

      The purpose of the study is to determine the safety and clinical benefit of the combinations
      of abiraterone acetate and prednisone or abiraterone and dexamethasone in prostate cancer
      patients. Prednisone will be given at one of three different dose schedules. Dexamethasone
      will be given at one dose schedule. This will include looking at what side effects occur and
      how often they occur. In addition the impact of the study drug on quality of life and pain
      will be evaluated. The study will also collect data on subsequent treatment of patients after
      they come off the study drug (approximately 4.5 years after the start of study treatment of
      the first subject participating in the study). By analyzing blood samples, the study aims to
      identify if some markers could help to understand if the treatment with abiraterone is
      effective and also help to understand if patients can become resistant.
    

Eligibility criteria:

        Inclusion Criteria:

        Have a histologically or cytologically confirmed adenocarcinoma of the prostate Have
        metastatic disease documented by positive bone scan or by computed tomography or magnetic
        resonance imaging Have prostate cancer progression documented by prostate specific antigen
        according to Prostate Cancer Working Group 2 or radiographic progression according to
        modified RECIST (response evaluation criteria in solid tumors, v1.1) criteria Be
        asymptomatic from prostate cancer. A score of 0-1 on BPI-SF Question #3 (worst pain in last
        24 hours) will be considered asymptomatic Be surgically or medically castrated, with
        testosterone levels of <50 ng/dL (<2.0 nmol/L). If the subject is being treated with
        luteinizing hormone releasing hormone (LHRH) agonists or antagonists (subjects who have not
        undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to Day
        1, Cycle 1 and must be continued throughout the study.

        Exclusion Criteria:

        Has a history of pituitary or adrenal dysfunction Has an active infection or other medical
        condition that would contraindicate corticosteroid use Has any chronic medical condition
        requiring corticosteroid treatment or has received prior corticosteroid treatment for
        prostate cancer Has a pathological finding consistent with small cell carcinoma of the
        prostate Has a known brain metastasis