c: Hematology laboratories include hemoglobin, hematocrit, white blood cell count with differential (including absolute eosinophil count) , and platelets. In addition, prothrombin time (P T/INR) and activated partial thromboplastin time (APTT) should be checked as clinically indicated. d: Chemistry laboratories include sodium, potassium, chloride, bicarbonate, urea nitrogen, creatinine, glucose, calcium, albumin , total protein, bilirubin, alan ine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase. e: Serum PSA should be obtained pre -treatment and on the day of surgery, and as clinically indicated thereafter according to institutional practices. f: At baseline (day 14) , collect 10 mL of blood into a 10 -mL ACD (acid citrate dextrose) tube [test code 4470; CPT code 86813]. g: Blood sample s will be collected at day 14 and again on the day of prostatectomy and at follow up visit . At each time point, 2 plain (red top) or SST (go ld top) tubes should be collected, each containing ≥5mL of blood. After centrifugation, serum should be transferred into plastic cryovials and frozen at – 20°C or colder until the time of analysis (see Section 5.4 ). h: Peripheral blood lymphocytes (PBLs) will be obtained by co llecting 200 mL of blood into 50 -mL heparinized conical tube s. PBLs will be prepared by Ficoll -Hypaque density gradient centrifugation according to standard protocols, and will be cryopreserved in a liquid nitrogen freezer at – 140°C for further batched analyses. i: Degarelix acetate may be administered 2 -14 days after the screening visit, and that day is designated as day + 14 for future reference. See also the treatment schema for further information on dosage and timing of degarelix acetat e. j: Harvested prostate gland to be evaluated for CD8+ T cell infiltration, as well as other secondary endpoints. k: Archival prostate core biopsies to be centrally reviewed at baseline prior to study entry; radical prostatectomy specimens to be processed at Johns Hopkins according to standard procedures. l: The post -operative evaluation (28 days after prostatectomy) may take place over the telephone or in person, but patients are required to have hematology and chemistry labs collected at this time -point for safety purposes . m: In addition, PSA should be measured every 3 (±1) months in the first year after prostatectomy, and every 6 (±2) months in the second and third years after prostatectomy . Androgen suppression with prostate GVAX and cyclophosphamide J1265 Johns Hopkins University 25 of 68 J1265 PROT (Vers) 1.4 113012 Table 1 B STUDY CALENDAR for ARM B (Experimental Arm) Every effort should be made to keep visits, tests, and procedures on schedule. Acceptable deviations are listed below . ARM B Screening Evaluation a Day 1 Day 2 Day 14 Radical Prostatectomy, Day 28 (± 3) Follow -up, 28 Days (±21) Post -op k l Informed consent X Medical history X X Review of medications X X Physical examination X X Vital signs X X Height and weight X Performance status X X X CT and bone scan b (X) Hematology labs c X X X Chemistry labs d X X X Serum PSA e X X HLA typing f X Sera for immunoassays g X X X Blood (200 mL) for PBLs h X X Cyclophosphamide dose X GVAX dose X Degarelix acetate dose X Toxicity assessment X--------------------------------------------------------------------------- X Vaccine site assessment X--------------------------------------------------------------------------- X Surgical specimen i X Pathologic review j X X a: The screening (pre -treatment) evaluation should be conducted within 3 weeks (±4 days) of starting protocol therapy. b: Staging CT (if allergic to CT scan contrast, obtain MRI with contrast) and bone scans should only be performed if clinically indicated, and are not mandat ory.