Clinical trial NCT00170157 (phase 2, status: completed)
Conditions: prostate adenocarcinoma, prostate carcinoma, recurrent prostate carcinoma, stage iii prostate cancer, stage iv prostate cancer
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31, D07.5, C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: bicalutamide, flutamide, goserelin acetate, ipilimumab, leuprolide acetate
SMILES: [H][C@]12SCC(C)=C(N1C(=O)[C@H]2NC(=O)[C@H](N)C1=CC=C(O)C=C1)C(O)=O, CC(C)C(=O)NC1=CC(=C(C=C1)[N+]([O-])=O)C(F)(F)F, CC(C)C[C@H](NC(=O)[C@@H](COC(C)(C)C)NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(=O)[C@H](CO)NC(=O)[C@H](CC1=CNC2=CC=CC=C12)NC(=O)[C@H](CC1=CN=CN1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCN=C(N)N)C(=O)N1CCC[C@H]1C(=O)NNC(N)=O, COC1=CC=CC=C1OCC(O)CO, CC(C)C[C@H](NC(=O)[C@@H](COC(C)(C)C)NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(=O)[C@H](CO)NC(=O)[C@H](CC1=CNC2=CC=CC=C12)NC(=O)[C@H](CC1=CN=CN1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCN=C(N)N)C(=O)N1CCC[C@H]1C(=O)NNC(N)=O
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