Docetaxel or Abiraterone Acetate With ADT in Treating Patients With Metastatic Hormone Sensitive Prostate Cancer
Condition: Castration-Sensitive Prostate Carcinoma; Metastatic Prostatic Adenocarcinoma; Stage IV Prostate Cancer; Stage IVA Prostate Cancer; Stage IVB Prostate Cancer
MeSH terms: Prostatic Neoplasms; Hypersensitivity
Intervention: Abiraterone Acetate; Antiandrogen Therapy; Docetaxel; Prednisone; Quality-of-Life Assessment; Questionnaire Administration
Intervention description: Given PO; Given per standard of care; Given IV; Given PO; Ancillary studies; Ancillary studies
Intervention MeSH terms: Ascorbic Acid; Prednisone; Cortisone; Docetaxel; Abiraterone Acetate; Methyltestosterone; Hormones; Estrogens, Conjugated (USP); Androgens; Androgen Antagonists
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well docetaxel or abiraterone acetate work when combined with
      androgen deprivation therapy (ADT) in treating patients with hormone sensitive prostate
      cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as
      docetaxel and abiraterone acetate, work in different ways to stop the growth of tumor cells,
      either by killing the cells, by stopping them from dividing, or by stopping them from
      spreading. Antihormone therapy, such as ADT may lessen the amount of androgen made by the
      body. It is not yet known whether docetaxel or abiraterone acetate work better when combined
      with ADT in treating patients with hormone sensitive prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically diagnosed adenocarcinoma of the prostate.

          -  Radiographically confirmed metastatic disease prior to patient enrollment. Metastatic
             disease can be confirmed based on conventional imaging (CT, MRI, nuclear medicine bone
             scan) or molecular imaging (fluciclovine-positron emission tomography (PET)/CT,
             prostate-specific membrane antigen (PSMA)-PET/CT, Choline-PET/CT etc).

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 2.

          -  Absolute neutrophil count (ANC) >= 1.5 k/uL.

          -  Platelets >= 100 k/uL.

          -  Hemoglobin >= 9 g/dL.

          -  Serum total bilirubin =< 1.5 times upper limit of normal (ULN) OR direct bilirubin =<
             ULN for subjects with total bilirubin >= 1.5 x ULN.

          -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2.5 x ULN OR =<
             4 x ULN for subjects with liver metastases.

          -  Creatinine < 1.5 x ULN OR

          -  Creatinine clearance > 50 mL/min for subject with creatinine levels > 1.5 x ULN by
             Cockcroft-Gault formula or standard institutional practice.

          -  Highly effective method of contraception for both male and female partners of subjects
             throughout the study and for at least 3 months after last study treatment
             administration if the risk of conception exists.

          -  Able to provide informed consent and willing to sign an approved consent form that
             conforms to federal and institutional guidelines.

          -  Recovery to baseline or =< grade 1 Common Terminology Criteria for Adverse Events
             (CTCAE) version (v)5.0 from toxicities related to any prior treatments, unless adverse
             event (AE)(s) are clinically nonsignificant and/or stable on supportive therapy as
             defined by the treating physician.

        Exclusion Criteria:

          -  No prior abiraterone or docetaxel therapy for metastatic hormone sensitive prostate
             cancer. Prior therapy with ADT or first generation anti-androgen receptor therapy
             (example: bicalutamide) is allowed.

          -  Completed any hormone therapy for localized prostate cancer and have recovery of
             testosterone (i.e. testosterone level is >50ng/dL).

          -  Patients have a histologic diagnosis of small cell prostate cancer or pure squamous
             cell prostate cancer.

          -  Known brain metastases or cranial epidural disease unless adequately treated with
             radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks
             before first dose of study treatment. Eligible subjects must be neurologically
             asymptomatic and without corticosteroid treatment at the time of first dose of study
             treatment.

          -  The subject has uncontrolled, significant intercurrent or recent illness including,
             but not limited to, the following conditions:

               -  Cardiovascular disorders:

                    -  Congestive heart failure New York Heart Association class 3 or 4, unstable
                       angina pectoris, serious cardiac arrhythmias within 3 months of study
                       enrollment.

                    -  Uncontrolled hypertension defined as sustained blood pressure (BP) > 170 mm
                       Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive
                       treatment.

                    -  Stroke (including transient ischemic attack (TIA)), myocardial infarction
                       (MI), or other ischemic event, or arterial thromboembolic event within 3
                       months before first dose.

               -  Other clinically significant disorders that would preclude safe study
                  participation. As defined by the treating physician.

          -  Known history of testing positive for human immunodeficiency virus (HIV) and cluster
             of differentiation 4 (CD4) count is below 200 or known acquired immunodeficiency
             syndrome diagnosis.

          -  Known history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at
             screening (positive HBV surface antigen or detectable HCV ribonucleic acid [RNA] if
             anti-HCV antibody screening test positive) and a detectable viral count at screening.

          -  Use of live virus vaccine within 4 weeks of the first dose of treatment or planned use
             while on trial for the duration of potential docetaxel treatment. Live vaccine use is
             acceptable after chemotherapy or for patients randomized to the abiraterone arm. There
             are no restrictions on inactive viruses.

          -  Known prior severe hypersensitivity to investigational product or any component in its
             formulations (National Cancer Institute [NCI] CTCAE v5.0 grade >= 3).