Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer
Prostate Adenocarcinoma, Prostate Carcinoma, Recurrent Prostate Carcinoma

About this trial
This is an interventional treatment trial for Prostate Adenocarcinoma
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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm I
Arm II
Patients receive either leuprolide acetate intramuscularly (IM) or goserelin subcutaneously (SC) on days 0, 28, and 56. Patients also receive oral flutamide three times daily or oral bicalutamide once daily. Treatment with antiandrogen (AA) therapy continues for 3 months (3-4 months for patients who initiated AA therapy <= 21 days prior to enrollment) in the absence of disease progression or unacceptable toxicity. Patients receive ipilimumab IV over 90 minutes on day 7 (within 7-28 days post-initiation of AA therapy for patients who initiated AA therapy <= 21 days prior to enrollment) of AA therapy.
Patients receive AA therapy as in arm I. Patients may crossover to arm II in the case of disease progression.