Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer
Condition: Prostate Adenocarcinoma; Prostate Carcinoma; Recurrent Prostate Carcinoma; Stage III Prostate Cancer; Stage IV Prostate Cancer
MeSH terms: Carcinoma; Prostatic Neoplasms
Intervention: Bicalutamide; Flutamide; Goserelin Acetate; Ipilimumab; Leuprolide Acetate; Pharmacological Study
Intervention description: Given orally; Given orally; Given SC; Given IV; Given IM; Correlative study
Intervention MeSH terms: Ipilimumab; Leuprolide; Goserelin; Bicalutamide; Flutamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 112.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such
      as leuprolide acetate, goserelin, flutamide, or bicalutamide may lessen the amount of
      androgens made by the body. Monoclonal antibodies, such as ipilimumab, can block cancer
      growth in different ways. Some block the ability of tumor cells to grow and spread. Others
      find tumor cells and help kill them or carry cancer-killing substances to them. Giving
      antihormone therapy together with ipilimumab may kill more tumor cells.

      PURPOSE: This randomized phase II trial is study how well giving hormone therapy and
      ipilimumab together works in treating patients with advanced prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  NOTE: All values must be obtained =< 14 prior to study entry

          -  Histologically confirmed adenocarcinoma of the prostate staged within 180 days of
             study enrollment, >cT2cN0/M0 stage with or without metastatic disease, with the
             exclusion of central nervous system (CNS) metastases; includes post radical
             prostatectomy patients with a rising PSA

          -  An initial PSA >= 4.0 ng/mL (Hybritech Assay)

          -  For those patients who have received hormone therapy =< 21 days, a documented PSA of
             >= 4.0 prior to initiation of hormone therapy is acceptable.

          -  For patients who are post radical prostatectomy, a rising PSA is acceptable.

          -  Adequate organ function defined as: WBC >= 3,000/uL; platelets >= 75,000/uL; total
             bilirubin =< 1.5 mg/dL; transaminases =< 2.5 x upper limit of normal (ULN); serum
             creatine =< 2.0 mg/dL or calculated creatinine clearance >= 60 mL/min

          -  ECOG performance status of 0-2

          -  Able to understand and sign informed consent

        Exclusion Criteria:

          -  Underlying other serious medical condition which, in the opinion of the investigator
             precludes study participation; this includes immune-suppressive disease such as AIDS
             or autoimmune disorders such as multiple sclerosis, lupus, or myasthenia gravis

          -  Patients not recovered from major infections and/or surgical procedures

          -  Prior hormonal therapy > 21 days prior to enrollment, including estrogens, LH/RH
             agonists, or antiandrogens

          -  Recent (=< 3 months of informed consent) usage of immune-suppressive medication
             including steroids, Immuran, Cyclosporin; topical or inhalational steroid use is
             permissible

          -  Prior systemic chemotherapy

          -  Prior radiation therapy to the prostate

          -  Prior malignancy, unless the patient has been cancer-free for five years or more

          -  Uncontrolled underlying medical or psychiatric illness, or serious active infections

          -  Patient unwilling to complete all required follow-up visits

          -  History of motor neuropathy considered of the autoimmune origin (e.g. Guillian-Barre
             Syndrome)

          -  Concurrent malignancy, except for adequately treated basal cell or squamous cell skin
             cancer

          -  For patients who elect to undergo the baseline transrectal needle biopsy of the
             prostate, current usage of systemic anticoagulation therapy, i.e. heparin or Coumadin
             or inability to discontinue aspirin, aspirin-containing products or ibuprofen for
             seven days prior to the prostate biopsies required for this study

          -  No other investigational drugs will be allowed during the study

          -  Other chemotherapy, radiation therapy, immunotherapy, hormonal therapy, or biologic
             therapy may not be used while the patient is on study