Abiraterone Prednisone and Hormonal Therapy Before and During Radiation Therapy in Localized Prostate Cancer
Condition: Adenocarcinoma of the Prostate; Stage II Prostate Cancer; Stage III Prostate Cancer; Stage IV Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: abiraterone acetate; prednisone; leuprolide acetate; laboratory biomarker analysis; external beam radiation therapy; goserelin acetate
Intervention description: Given PO; Given PO; Given via injection; Correlative study; Undergo radiotherapy; Given via injection
Intervention MeSH terms: Prednisone; Leuprolide; Goserelin; Abiraterone Acetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies the side effects and how well abiraterone acetate, prednisone,
      and leuprolide acetate or goserelin before and during radiation therapy works in treating
      patients with localized or locally advanced prostate cancer. Androgens can cause the growth
      of prostate cancer cells. Antihormone therapy, such as abiraterone acetate, leuprolide
      acetate, and goserelin, may lessen the amount of androgens made by the body. Radiation
      therapy uses high-energy x-rays to kill tumor cells. Giving abiraterone acetate and
      leuprolide acetate or goserelin before or together with radiation therapy may be an effective
      treatment for prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  Patients must allow biopsy prior to neoadjuvant therapy and at the time of fiducial
             placement

          -  Written Authorization for Use and Release of Health and Research Study Information has
             been obtained

          -  Histologically proven adenocarcinoma of the prostate

          -  Patients must be candidates for short or long term androgen deprivation in combination
             with external beam radiotherapy (RT) based on the following criteria:

               -  Intermediate Risk Disease: T2b/c, or Gleason 7, or Prostate Specific Antigen
                  10-20

               -  High Risk Disease: Gleason 8-10, or Prostate specific antigen> 20, or T3/4

          -  Patients may not have received any prior pharmacologic therapy or radiation therapy
             (RT) for prostate cancer

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 2

          -  Karnofsky >= 60%

          -  Eligibility of patients receiving any medications or substances known to affect or
             with the potential to affect the androgen axis will be determined following review of
             their case by the Principal Investigator

          -  White blood cell count: >= 3,000/mm^3

          -  Absolute granulocyte count: >= 1,000/mm^3

          -  Platelets: >= 100,000/mm^3

          -  Hemoglobin >= 10g/dL

          -  Potassium >= 3.5 mmol/L

          -  Serum creatinine: =< 1.5 x upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST) < 2.5 x ULN

          -  Alanine transaminase (ALT) < 2.5 x ULN

          -  Total bilirubin: =< 1.5 x ULN (except for patients with documented Gilbert's disease)

        Exclusion Criteria:

          -  Patients may not be receiving any investigational agents

          -  Concurrent enrollment in another clinical investigational drug or device study is
             prohibited

          -  The concurrent administration of other anticancer therapy, including cytotoxic or
             hormonal agents (except Luteinizing hormone releasing hormone agonists), or
             immunotherapy, is prohibited during neoadjuvant concurrent and adjuvant therapy

          -  Patients who are currently receiving active therapy for other neoplastic disorders
             will not be eligible

          -  Patients with histologic evidence of small cell carcinoma of the prostate will not be
             eligible

          -  Patients with hypogonadism or severe androgen deficiency as defined by serum
             testosterone less than 100 ng/dL will not be eligible

          -  History of pituitary or adrenal dysfunction

          -  Patients who are receiving any androgens, estrogens or progestational agents, or who
             received any of these agents within the 6 months prior to evaluation will not be
             eligible

          -  Patients who are taking drugs which affect androgen metabolism (e.g. spironolactone,
             ketoconazole, finasteride, dutasteride) will not be eligible

          -  Concomitant therapy with any of the following listed is prohibited: 5 alpha-reductase
             inhibitor (finasteride, dutasteride); ketoconazole, diethylstilbestrol, and other
             preparations such as saw palmetto thought to have endocrine effects on prostate
             cancer; radiopharmaceuticals such as strontium (89Sr) or samarium (153Sm); Aldactone,
             Spironol (spironolactone); estrogens, testosterone, progesterones, herbal medications

          -  Patients who received any of these agents within the 6 months prior to evaluation will
             be reviewed for eligibility by the Principal Investigator on a case by case basis

          -  Use of other investigational drug therapy for any reason is prohibited

          -  Patients with inflammatory bowel disease or other autoimmune conditions which might
             affect the radiated colon or rectum

          -  Patients with uncontrolled intercurrent illness including, but not limited to, ongoing
             or active infection, unstable angina pectoris, cardiac arrhythmia which is symptomatic
             or requires active therapy, recent deep venous thrombosis, pulmonary emboli,
             cerebrovascular accident or ischemia will not be eligible

          -  Patients who have chronic active hepatitis or acute hepatitis will not be eligible

          -  Patients with dementia/psychiatric illness/social situations that would limit
             compliance with study requirements or would prohibit the understanding and/or giving
             of informed consent will not be eligible

          -  Patients with medical conditions, which, in the opinion of the investigators, would
             jeopardize either the patient or the integrity of the data obtained will not be
             eligible

          -  Uncontrolled hypertension within the screening period (systolic blood pressure [BP] >=
             160 mmHg or diastolic BP >= 95 mmHg)

          -  Patients with a history of hypertension are allowed provided blood pressure is
             controlled by anti-hypertensive therapy

          -  History of congestive heart failure of any severity

          -  Other active malignancy, except non-melanoma skin cancer and superficial bladder
             cancer

          -  History of gastrointestinal disorders (medical disorders or extensive surgery) which
             may interfere with the absorption of the study drug

          -  Patients with diabetes not controlled with diet alone (i.e. requiring insulin or oral
             hypoglycemics)

          -  Patients unwilling to use contraceptives while on study