• Pipette the serum into 10 cryotubes (about 0.5 mL/tube) . • Store cryotubes frozen, below –20oC (–70oC preferred ), until the time of analysis. 5.5 Follow -Up Evaluation s A follow -up visit scheduled for 28 (±21) days after radical prostatectomy may occur in the outpatient clinic or by telephone interview. Required evaluation s during this follow -up visit are listed below. Patients should then continue to be followed by their treating urologist according to standard institutional practices. • performance status • review of toxicity/adverse events • assessment for vaccine site reactio ns Patients withdrawing from t he study early because of adverse event s should be followed until the adverse event has either resolved or stabiliz ed. Reasons for premature withdrawal should be determined and documented . In addition, patients will be require d to have a structured assessment of post- operative PSA measurements for 3 years. In the first year after prostatectomy, PSA will be measured every 3 months (±1 mo). In the second and third years after prostatectomy, PSA will be measured every 6 months (±2 mo). These PSA measurements may be obtained outside of Johns Hopkins , but the results need to be made available to the study team. Long -Term Follow -Up Protocol . All patients that have received GVAX will also be encouraged to enter a separate long -term follow -up protocol to assess for potential late toxicities of GVAX ( e.g. autoimmune disease, second malignancies). This long -term follow -up protocol will involve a nnual visits for 3 years. 5.6 Duration of Therapy Participation in this study will be terminated for any of the following reasons listed below: • the patient decides to withdraw from the study (withdrawal of consent) due to unacceptable toxicities or for any other reason • the patient completes all of the protocol procedures and follow -up requirements Androgen suppression with prostate GVAX and cyclophosphamide J1265 Johns Hopkins University 28 of 68 J1265 PROT (Vers) 1.4 113012 • there are adverse events that, in the judgment of the investigator, may cause severe or permanent injury or are incompatible with continuation on study • there are major violations to the study protocol or the patient is noncompliant with treatments , as judged by the investigator • the patient experiences concurrent illness or a change in his condition that, in the judgment of the investigator, renders him unacceptable for furthe r treatment on study • the patient dies • the patient is lost to follow -up • the study is prematurely terminated for safety or feasibility concerns or other reasons Patients should be removed from the study when any of the above criteria are met. Beca use an excessive rate of withdrawals can render the study uninterpretable, unnecessary withdrawal of patients should be avoided if possible . When a patient leaves the study early, the investigator should make every effort to cont act the patient and to perf orm the final follow -up evaluation (even by telephone interview) . The reason for removal of a patient from the study, and the date of removal, must be appropriately documented. Patients will be replaced if they are removed from the study after signing the informed consent but before receiving degarelix, cyclophosphamide, or GVAX . Patients receiving at least one dose of the study drugs will be included in safety analyses, and those also undergoing prostatectomy will be used for the efficacy analyses . 6. THERAPEUTIC AGENT S 6.1 Prostate GVAX Immunotherapy 6.1.1 Dosage, Formulation, and Administration The prostate GVAX immunotherapy will consist of 2.5 × 108 cells from the AAV genomic GM -CSF–transduced PC3 Clinical Lot and 1.6 × 108 cells from the AAV genomic GM-CSF–transduced LNCaP Clinical Lot. GVAX will only be given to patients in arm B. Prostate GVAX will be administered as five 0.8 -mL intradermal injections of PC3 (2.5 × 108 cells) and five 0.5- mL intradermal injections of LNCaP ( 1.6 × 108 cells), for a total dose of 4.1 × 108 cells. In the case of PC3 , eac h vile is filled with 1mL of cells in suspension.