couriers to the Laboratory of Tumor Immunology and Biology. 4.2.1 Protocol Completion/ Sample Destruction Once primary research objectives for the protocol are achieved, intramural researchers can request access to remaining samples, provided th ey have an IRB-approve d protocol and patient consent.Samples and associated data will be stored permanently unless the patient withdraws consent. If the patient withdraws consent the participant’s data will be excluded from future distributions, but data that have already been distributed for approved research use will not be able to be retrieved. The PI will report destroyed samples to the IRB if samples become unsalvageable or destroyed by environmental conditions (ex. br oken freezer or lack of dry ice in shipping container) or if a patient chooses to withdraw his/her consent. Samples wi ll also be reported as lost if they are lost in transit or misplaced by a researcher. Freezer problems, lost samples or other problems associated with samples will also be reported to the IRB, the NCI Clinical Director, and the office of the CCR, NCI. 5 SUPPORTIVE CARE For both the administration of PSA-TRICOM and enzalutamide, antiemetics, stool softeners and antidiarrheal agents may be administered as requi red, but are not anticipated to be needed and should not be used prophylactically on the first cycle. The selection of the specific antiemetic regimen is at the discretion of the treating physician. Antiemetic regimens will not include steroids. Other supportive care with blood components, antib iotics, analgesics, general medical therapy, etc., will be delivered as required. Any patients taking antibiotics for any reason must complete that course of therapy and be free of evidence of further infection before receiving any dose of vaccine. Symptomatic anemia should be treated with appropriate red blood cell or erythropoietin support. Thrombocytopenia should be treated conservativel y. In the absence of bleeding or a planned invasive procedure, platelet transfusions should be given for a platelet count below 10,000/mm 3. If invasive procedures are planne d or the patient develops bleeding, platelet transfusions should be administered in accordance with the standard of practice, usually maintaining a platelet count of > 50,000/mm 3. Any evidence of disseminated intravascular coagulation (DIC), hemolytic uremic syndrome (HUS), or thrombotic thrombocytopenic purpura (TTP) including thrombocytopenia, hemolytic anemia, renal failure, fever or neurologic chan ges should be thoroughly evaluated and closely monitored and supported as clinically indicated. Version Date: 12/5/17 Abbreviated Title : Enzalutamide in non-met CSPC 395.1 E XCLUDED MEDICATIONS While patients on protocol treatment, all medicati ons required for the health of the patient are allowed with the following exceptions : xConcurrent chemotherapy xConcurrent radiation therapy xConcurrent immunotherapy xConcurrent anti-cancer radionuclides xConcurrent systemic corticosteroid use (daily or every other day for continued use > 14 days ; See section 2.1.2) xConcomitant use of secondary hormonal treatments 5.2 T REATMENT OF VACCINIA VACCINATION COMPLICATION 5.2.1 Vaccinia Immune Globulin: First-line treatment of some of the complications of vaccinia caused by dissemination of vaccinia virus (severe cases of inadvertent inoculati on involving extensive lesions or if comorbid conditions exist, severe cases of generalized vaccinia in patients that are systemically ill andwhose condition might be toxic or who have serious underlying immunos uppressive illnesses, eczema vaccinatum, and progressive vaccinia) is with VIG. VIG is contraindicated, however, for the treatment of isolated vaccinial keratitis. VIG is a sterile solution of the immunoglobulin fraction of pooled plasma from individuals inoculated with vaccinia vaccine. VIG is an investigational agent available through the CDC’s Strategic NationalPharmaceutical Stockpile under an IND protocol by contacting the CDC’s Smallpox Vaccine Adverse Events Clinician Information Line at 1-877-554-4625. Upon receipt of a call from apatient or upon direct observation of a patient or contact who ma nifests signs and symptoms of any of the above conditions, the investigator s hould place a call to the CDC as soon as possible: 1) to initiate review of the clinical case, 2) to seek consultation on the appropriateness of VIG therapy, 3) to determine the appropriate VIG dose and dosing method for administration, if VIG therapy is required, and 4) to determine how to access and have the appropriate doses of VIG delivered. Early institution of VIG therapy is advised following recognition of clinical symptomscompatible with some vaccinia complications (eczema vaccinatum, severe generalized vaccinia,progressive vaccinia, and some cases of inadve rtent inoculation). The effectiveness of VIG therapy appears to be time dependent. VIG has not proven to be of bene fit in the treatment of post-vaccinial encephalitis, and is contraindicated for treatment of isolated vaccinial keratitis due to the increased risk of corneal scarring.A new intravenous formulation of VIG is available through the CDC, which has a lower level ofaggregated protein, allowing it to be used by e ither the IM or IV route. This formulation will most likely be preferred for administration and investigators will be instructed by the CDCregarding appropriate dosing and method of administration based on formulation and availability. There is no guarantee that VIG w ill successfully treat complications. At present, there are no other anti-viral therapies of proven benefit for the treatment of vaccinia-relatedcomplications. Version Date: 12/5/17 Abbreviated Title : Enzalutamide in non-met CSPC 405.2.2 Cidofovir (Vistide®, Gilead Sciences): Cidofovir is an FDA-approved antiviral drug for the treatment of CMV retinitis among patients with AIDS. Cell-based in vitro studies and animal model studies have demonstrated antiviral activity of this agent against certain orthopoxvi ruses.