thyroxine replacement and insulin replacement) . Injection site reactions: For patients receiving GVAX , EMLA cream (or a similar product) should be applied to the site of vaccination at a dose of approxi mately 2.5 grams per site approximately one hour prior to vaccination to mitigate injection -site pain. Nausea/ vomiting: GVAX and low -dose cyclophosphamide do not typically induce nausea or vomiting. However, prochlorperazine may be given for this indicatio n at a dose of 10 mg by mouth or intravenously as frequently as every 6 hours. Prophylactic antiemetic therapy at the discretion of the treating physician is allowed. Durin g treatment (and for at least 60 minutes afterwards), patients should be observed for adverse reactions. Treatment areas should have ACLS -certified personnel on site, as well as access to appropriate supportive care modalities including but not limited to oxygen administration, corticosteroids, antihistamines and catecholamines. Any or al l of these modalities may be used in the case of hypersensitivity reactions or anaphylactic reactions. Diet will not be regulated on this study, except as required by standard pre -operative protocols. The use of vitamins, nutritional supplements, homeopathic medications, and herbal remedies is Androgen suppression with prostate GVAX and cyclophosphamide J1265 Johns Hopkins University 36 of 68 J1265 PROT (Vers) 1.4 113012 discourag ed and must be approved by the principal i nvestigator. Multivitamin tablets and calcium supplementation are generally permitted . Patients should receive full supportive care as appropriate, including transfus ions of blood and blood products, erythropoietin, antibiotics, antiemetics, analgesics, electrolyte replacement, and other supportive measures. The indications, doses, and dates of such treatments should be recorded on the CRFs. Use of growth factors such as filgrastim/peg -filgrastim (G- CSF) or sargramostim (GM -CSF) is discouraged . 6.5 Drug Interactions/C autions Within 30 days of administration of study drug(s), patients should not receive other vaccines including but not limited to the live rotavirus vacci ne, the live BCG (bacillus Calmette- Guerin ) vaccine, the live influenza vaccine, the live measles vaccine, the live mumps vaccine, the live poliovirus vaccine, the live rubella vaccine, the smallpox vaccine, the typhoid vaccine, the varicella vaccine, and the yellow fever vaccine. The following list of medications should generally be taken with caution by patients on chronic cyclophosphamide: allopurinol, cyclosporine, etanercept, hydrochlorothiazide, nevirapine, ondansetron, pentostatin, St John’s wort, ta moxifen, trastuzumab, and warfarin . In the present study, however, because only a single low -dose administration of cyclophosphamide will be given, these medications are not prohibited. Nevertheless, the principal investigator must be notified if a patient is taking any of these listed agen ts. 6.6 Drug Dispensing Log Study site personnel should record all study drugs admin istered during this trial on the drug - dispensing log. This log may also be reviewed by the research pharmacist. The drug dispensing log will contain the following informati on: • patient study identification number • date(s) of study drug administered • doses/ quantities of study drug (s) administered • signature of the investigator or authorized research nurse 6.7 Pregnancy Men with partners of child -bearing potential must agree to use adequate contraception (hormonal and/or barrier methods; or abstinence) for the duration of the study and for 3 months aft er the last dose of study drug(s) . 7. ADVERSE EVENTS AND REPORTING REQUIREMENTS An adverse event (AE) is defined as any untoward medical occurrence ( symptom, sign, illness or experience) that develops or worsens in a research patient during a clinical study or within 30 days post -treatment, regardless of causality. This includes adverse clinical or laboratory findings, any adverse d rug reaction (ADR), an illness with onset during the study, or an exacerbation of a preexisting illness or condition. Cancer progression should not be considered an AE, unless the investigator believes that the study treatment exacerbated the patient’s condition. Exceptions are if disease progression results in death or hospitalization while a patient is on study, in whi ch case the disease progression is considered a serious AE. Abnormal findings on physical examination or diagnostic procedures are also considered AEs if: they are associated with clinical signs or symptoms; they require therapeutic intervention or additio nal diagnostic testing; they lead to dose modifications/termination of the study drug; or they are considered clinically significant by the Androgen suppression with prostate GVAX and cyclophosphamide J1265 Johns Hopkins University 37 of 68 J1265 PROT (Vers) 1.4 113012 investigator. All observed or reported AEs, regardless of their suspected causal relationship to the study drug, sho uld be recorded on the Case Report Form (CRF). The NCI CTCAE v ersion 4.0 will be used for adverse event descriptions and grading (http://ctep.cancer.gov/pr otocolDevelopment/electronic_applications/docs/ctcaev3.pdf ). These criteria are summarized in Appendix B. The type and severity of an AE, as well as its potential link to the study drug (s), will determine whether the event requires expedited reporting in a ddition to routine reporting. For all AEs, the investigator must pursue and obtain information to adequately determine the causality and outcome of the event, and to assess whether it meets criteria for a serious AE. In addition, follow -up of AE s should continue until the event and any sequela e resolve or stabilize at a level acceptable to the investi gator and/ or the medical monito r. 7.1 Recording and Grading 7.1.1 Recording All observed or volunteered adverse events, regardless of treatment group, severit y, suspected causality, expectedness, or serio usness will be documented on the CRF . A clinically significant change in a physical examination finding or an abnormal test result (i.e., labora tory value ) should be recorded as an AE, if it: • is associated with accompanying symptoms • requires additional diagnostic testing o r medical or surgical intervention • leads to a change in study dosing or discontinuation from the study • requires additional concomitant drug treatment or other therapy, or • is considered clinically significant by the investigator An abnormal test result that is subsequently determined to be an error does not requi re recording as an AE even if it originally met one or more of the above criteria. 7.1.2 Grading severity All adverse events will be grad ed for intensity on a s cale of 0 to 5, according to the NCI CTCAE v ersion 4.0 (see Table 2 and Appendix B). These criteria can be found at http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf Table 2 Intensity of Adverse Event Grade Description 0 (none) No adverse event or within normal limits. 1 (mild) Transient or mild discomfort; generally non -progressive; no limitation in daily activities; no medical intervention required. 2 (moderate) Mild/moderate limitation in daily activities; some assistance may be required; no/minimal medical intervention required. 3 (severe) Marked limitation in daily activities; some assistance usually required; medical intervention is required. 4 (life -threatening) Extreme limitation in daily activities; major assistance required; significant medical intervention required. 5 (death) Fatal adverse event. Androgen suppression with prostate GVAX and cyclophosphamide J1265 Johns Hopkins University 38 of 68 J1265 PROT (Vers) 1.4 113012 7.1.3 Attributing causality After grading for severity, the investigator must evaluate all clinical AEs and abnormal laboratory values for possible causal relationship to the study drug(s) . Causality a ttribution will be decided using the criteria outlined in Table 3. Table 3 Relationship of Adverse Event to Study Drug Relationship Description Unrelated AE is clearly not related to the study drug (An event that does not meet any of the criteria below). Unlikely AE is doubtfully related to the study drug (An event that follows a reasonable temporal sequence after drug administration; that follows a known or expected response pattern; but that could more reasonably be explained by other characteristics of the patient’s clinical state). Possible AE may be related to the study drug (An event that follows a reasonable temporal sequence after drug administration; that follows a known or expected response pattern; but that could just as readily be attributed to a number of other factors). Probable AE is likely related to the study drug (An event that follows a reasonable temporal sequence after drug administration; that follows a known or expected response pattern; that is confirmed by stopping/reducing the drug dose; and that could not be reasonably explained by the characte ristics of the patient’s clinical state). Definite AE is clearly related to the study drug (An event that follows a reasonable temporal sequence after drug administration; that follows a known or expected response pattern; and that is confirmed by improve ment on stopping/reducing the drug dose and reappearance on repeated exposure). Abnormal laboratory values of clinical significance that were present at baseline and did not change in severity or frequency during experimental therapy and those that can obviously be attributed to underlying disease will be recorded as unrelat ed and will not be considered when evaluatin g study drug toxicity . 7.2 Unexpected Adverse Events An unexpected adverse event is any event not associated by nature or intensity with the investigational agent (s) under study. A c omprehensive list of adverse event s and potential r isks related to prostate GVAX and cyclophosphamide are provided in this Protocol and in the Consent form . Both of these agents have been reported to cause allergic reactions in very rare instances .