Antiandrogen Therapy, Abiraterone Acetate, and Prednisone With or Without Neutron Radiation Therapy in Treating Patients With Prostate Cancer
Condition: Castration-Sensitive Prostate Carcinoma; Metastatic Malignant Neoplasm in the Bone; Metastatic Prostate Carcinoma; Prostate Adenocarcinoma; Prostate Small Cell Neuroendocrine Carcinoma; Stage IV Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8
MeSH terms: Carcinoma; Prostatic Neoplasms; Neoplasms; Carcinoma, Neuroendocrine; Carcinoma, Small Cell
Intervention: Antiandrogen Therapy; Abiraterone Acetate; Prednisone; Radiation Therapy
Intervention description: Undergo ADT; Undergo Abiraterone Acetate Treatment SOC; Undergo Prednisone Treatment SOC; Undergo neutron radiation therapy
Intervention MeSH terms: Ascorbic Acid; Prednisone; Cortisone; Methyltestosterone; Abiraterone Acetate; 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: 10.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate Cancer

Summary:

      This phase II trial studies how well antiandrogen therapy, abiraterone acetate, and
      prednisone with or without neutron radiation therapy work in treating patients with prostate
      cancer. Hormone therapy such as antiandrogen therapy may fight prostate cancer by blocking
      the production and interfering with the action of hormones. Abiraterone acetate may stop the
      growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in
      chemotherapy, such as prednisone, 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. Neutron radiation therapy uses high energy neutrons to kill tumor cells and shrink
      tumors. It is not yet known whether antiandrogen therapy, abiraterone acetate, and prednisone
      with or without neutron radiation therapy may work better in treating patients with prostate
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically proven (either histologic or cytologic) diagnosis of prostate
             adenocarcinoma with < 50% neuroendocrine differentiation or small cell histology.

          -  At least one site of nodal or distant metastatic disease that is measurable by
             Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, or a bony
             metastasis that is evaluable on both computed tomography (CT) and bone scan.

          -  No prior orchiectomy.

          -  No androgen deprivation therapy such as treatment with antiandrogens, luteinizing
             hormone-releasing hormone (LHRH) agonists or antagonists for at least one year prior
             to trial enrollment, and testosterone must be inside normal range prior to trial
             enrollment if there is prior history of ADT.

          -  No other systemic anti-cancer therapy for at least 1-year prior to enrollment.

          -  Prior prostate-directed therapies such as prostatectomy or cryotherapy are allowed.

          -  Prior radiation treatments are allowed (prostate or metastatic sites) but must have
             been completed at least 3 months prior to starting ADT for this trial.

          -  White blood cell (WBC) > 3000/mm^3.

          -  Absolute neutrophil count (ANC) > 1000/mm^3.

          -  Platelets > 100,000/mm^3.

          -  Creatinine < 1.5 institutional upper limit of normal (ULN) or calculated creatinine
             clearance > 30 ml/min.

          -  Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin
             < 3 x institutional ULN (unless patient has documented Gilbert's syndrome).

          -  No steroids for at least 2 weeks prior to enrollment, and patient must not be expected
             to require steroids during the study period, other than the typical low dose steroid
             that is given with abiraterone (typically prednisone or prednisolone at 5 mg twice
             daily).

          -  Zubrod performance status 0-2.

          -  Patient must sign study specific informed consent prior to study entry.

          -  Men who are sexually active must use medically acceptable forms of contraception.

        Exclusion Criteria:

          -  Other illnesses with a life expectancy of less than 6 months, including but not
             limited to unstable angina, symptomatic congestive heart failure, cardiac arrhythmias.

          -  Psychological or social issues that would prevent patients from informed consent or
             complying with study requirements.

          -  Subject has a history of unexplained loss of consciousness or transient ischemic
             attack within 12 months of treatment start.

          -  Individuals on active treatment for a different cancer are excluded. Individuals with
             a history of other malignancies are eligible if they are deemed by the investigator to
             be at low risk for recurrence of that malignancy.

          -  Known brain metastasis.

          -  Known allergies, hypersensitivity, or intolerance to abiraterone or prednisone.

          -  Prior ADT less than a year, or greater than two months, prior to trial enrollment or
             prior ADT with testosterone less than normal.

          -  There is a potential drug interaction when abiraterone is concomitantly used with a
             CYP2D6 substrate narrow therapeutic index (e.g., thioridazine, dextromethorphan), or
             strong CYP3A4 inhibitors (e.g., atazanavir, erythromycin, indinavir, itraconazole,
             ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and
             voriconazole) or strong inducers (e.g., carbamazepine, phenobarbital, phenytoin,
             rifabutin, rifampin, rifapentine). Caution should be used when patients are on one of
             these drugs.

          -  Patients with a history of pituitary or adrenal dysfunction, active or symptomatic
             viral hepatitis, human immunodeficiency virus (HIV), or chronic liver disease are not
             eligible.

          -  Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg
             prednisone/prednisolone once daily.