Docetaxel or Abiraterone Acetate With ADT in Treating Patients With Metastatic Hormone Sensitive Prostate Cancer

PRIMARY OBJECTIVES:

I. To assess the impact of abiraterone acetate (abiraterone) and docetaxel on total quality
of life between screening and month 12 of the study.

SECONDARY OBJECTIVES:

I. To assess PSA response rates across the entire population and compared between groups.

II. To assess impact of abiraterone and docetaxel on additional quality of life measurements
and quality of life trends throughout the duration of the study.

III. To assess the potential clinical efficacy between treatment groups.

Inclusion Criteria:

- Histologically diagnosed adenocarcinoma of the prostate.

- Radiographically confirmed metastatic disease within 60 days of study enrollment.

- 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 ? ULN.

- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2.5 ? ULN OR =<
4 ? ULN for subjects with liver metastases.

- Creatinine < 1.5 ? ULN OR

- Creatinine clearance > 50 mL/min for subject with creatinine levels > 1.5 ? ULN.

- Prothrombin time (PT) or international normalized ratio (INR), partial thromboplastin
time (PTT) =< 1.5 ? ULN

- 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.

Exclusion Criteria:

- 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.

- No prior systemic therapy for metastatic prostate cancer except for ADT given
concurrently with definitive radiation therapy.

- Completed any hormone therapy for localized prostate cancer at least 9 months
previously.

- Patients must not 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 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).