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12 references

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Bicalutamide monotherapy versus flutamide plus goserelin in prostate cancer patients: results of an Italian Prostate Cancer Project study. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 1999;17(7):2027-38. Epub 1999/11/24. PubMed PMID: 10561254.  
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20.Kantoff PW, Schuetz TJ, Blumenstein BA, Glode LM, Bilhartz DL, Wyand M, et al. Overall survival analysis of a phase II randomized controlled trial of a Poxviral-based PSA-targeted immunotherapy in metastatic castration-resistant prostate cancer. J Clin Oncol. 2010;28(7):1099-105. PubMed PMID: 20100959.  
21.Gulley JL, Arlen PM, Madan RA, Tsang KY, Pazdur MP, Skarupa L, et al. Immunologic and prognostic factors associated with overall survival employing a poxviral-based PSA vaccine in metastatic castrate-resistant prostate cancer. Cancer Immunol Immunother. 2010;59(5):663-74. Epub 2009/11/06. doi: 10.1007/s00262-009-0782-8. PubMed PMID: 19890632; PubMed Central PMCID: PMC2832083.  
22.clinicaltrials.gov. A Phase 3 Efficacy Study of a Recombinant Vaccinia Virus Vaccine to Treat Metastatic Prostate Cancer (Prospect) [cited 2012 August 1]. Available from: http://clinicaltrials.gov/ct2/show/NCT01322490?term=PROSPECT&rank=6.  
23.Mercader M, Bodner BK, Moser MT, Kwon PS, Park ES, Manecke RG, et al. T cell infiltration of the prostate induced by androgen withdrawal in patients with prostate cancer. Proceedings of the National Academy of Sciences of the United States of America. 2001;98(25):14565-70. PubMed PMID: 11734652.  
24.Goldberg GL, Sutherland JS, Hammet MV, Milton MK, Heng TS, Chidgey AP, et al. Sex steroid ablation enhances lymphoid recovery following autologous hematopoietic stem cell transplantation. Transplantation. 2005;80(11):1604-13. PubMed PMID: 16371932.  
25.Drake CG, Doody AD, Mihalyo MA, Huang CT, Kelleher E, Ravi S, et al. Androgen ablation mitigates tolerance to a prostate/prostate cancer-restricted antigen. Cancer cell. 2005;7(3):239-49. PubMed PMID: 15766662.  
26.Sutherland JS, Goldberg GL, Hammett MV, Uldrich AP, Berzins SP, Heng TS, et al.  
Activation of thymic regeneration in mice and humans following androgen blockade. J Immunol. 2005;175(4):2741-53. PubMed PMID: 16081852.  
27.Vaccine Therapy With PROSTVAC/TRICOM and Flutamide Versus Flutamide Alone to Treat Prostate Cancer [cited 2012 August 5]. Available from: http://clinicaltrials.gov/ct2/show/NCT00450463.  
28.Bubley GJ, Carducci M, Dahut W, Dawson N, Daliani D, Eisenberger M, et al. Eligibility and response guidelines for phase II clinical trials in androgen-independent prostate cancer: recommendations from the Prostate-Specific Antigen Working Group. J Clin Oncol.  
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29.Bilusic M, Gulley JL, Heery C, Apolo AB, Arlen P, Rauckhorst M, et al. A randomized phase II study of flutamide with or without PSA-TRICOM in nonmetastatic castration-resistant prostate cancer. J Clin Oncol 29: 2011 (suppl 7; abstr 163).  
30.Scher HI, Halabi S, Tannock I, Morris M, Sternberg CN, Carducci MA, et al. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol. 2008;26(7):1148-59. Epub 2008/03/04. doi: 26/7/1148 [pii] 10.1200/JCO.2007.12.4487. PubMed PMID: 18309951.  
31.Hurwitz AA, Foster BA, Allison JP, Greenberg NM, Kwon ED. The TRAMP mouse as a model for prostate cancer. Curr Protoc Immunol. 2001;Chapter 20:Unit 20 5. Epub 2008/04/25. doi: 10.1002/0471142735.im2005s45. PubMed PMID: 18432778.  
32.Farsaci B, Higgins JP, Hodge JW. Consequence of dose scheduling of sunitinib on host immune response elements and vaccine combination therapy. Int J Cancer. 2012;130(8):194859. Epub 2011/06/03. doi: 10.1002/ijc.26219. PubMed PMID: 21633954; PubMed Central PMCID: PMC3232304.  
33.Garnett CT, Schlom J, Hodge JW. Combination of docetaxel and recombinant vaccine enhances T-cell responses and antitumor activity: effects of docetaxel on immune enhancement. Clin Cancer Res. 2008;14(11):3536-44. Epub 2008/06/04. doi: 14/11/3536 [pii]
10.1158/1078-0432.CCR-07-4025. PubMed PMID: 18519787; PubMed Central PMCID:
PMC2682419.  
34.Aymeric L, Apetoh L, Ghiringhelli F, Tesniere A, Martins I, Kroemer G, et al. Tumor cell death and ATP release prime dendritic cells and efficient anticancer immunity. Cancer Res. 2010;70(3):855-8. Epub 2010/01/21. doi: 0008-5472.CAN-09-3566 [pii] 10.1158/0008-5472.CAN-09-3566 [doi]. PubMed PMID: 20086177.  
35.Ullrich E, Bonmort M, Mignot G, Kroemer G, Zitvogel L. Tumor stress, cell death and the ensuing immune response. Cell Death Differ. 2008;15(1):21-8. Epub 2007/11/10. doi: 4402266 [pii] 10.1038/sj.cdd.4402266. PubMed PMID: 17992190.  
36.Crook JM, Szumacher E, Malone S, Huan S, Segal R. Intermittent androgen suppression in the management of prostate cancer. Urology. 1999;53(3):530-4. Epub 1999/03/30. PubMed PMID: 10096379.  
37.Klotz L, O'Callaghan CJ, Ding K, Dearnaley DP, Higano CS, Horwitz EM, et al. A phase III
randomized trial comparing intermittent versus continuous androgen suppression for patients with PSA progression after radical therapy: NCIC CTG PR.7/SWOG JPR.7/CTSU JPR.7/UK Intercontinental Trial CRUKE/01/013. J Clin Oncol 29: 2011 (suppl 7; abstr 3)
38.Vergati M, Cereda V, Madan RA, Gulley JL, Huen NY, Rogers CJ, et al. Analysis of circulating regulatory T cells in patients with metastatic prostate cancer pre- versus postvaccination. Cancer Immunol Immunother. 2011;60(2):197-206. Epub 2010/10/27. doi:
10.1007/s00262-010-0927-9. PubMed PMID: 20976449; PubMed Central PMCID: PMC3202216.  
39.Tesniere A, Panaretakis T, Kepp O, Apetoh L, Ghiringhelli F, Zitvogel L, et al. Molecular characteristics of immunogenic cancer cell death. Cell Death Differ. 2008;15(1):3-12. Epub 2007/11/17. doi: 4402269 [pii] 10.1038/sj.cdd.4402269 [doi]. PubMed PMID: 18007663.  
40.Hodi FS, O'Day SJ, McDermott DF, Weber RW, Sosman JA, Haanen JB, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med.  
2010;363(8):711-23. Epub 2010/06/08. doi: NEJMoa1003466 [pii] 10.1056/NEJMoa1003466. PubMed PMID: 20525992.  
41.Madan RA, Gulley JL, Fojo T, Dahut WL. Therapeutic cancer vaccines in prostate cancer: the paradox of improved survival without changes in time to progression. Oncologist. 2010;15(9):969-75. Epub 2010/08/28. doi: theoncologist.2010-0129 [pii] 10.1634/theoncologist.2010-0129. PubMed PMID: 20798195; PubMed Central PMCID: PMC3228037.  
42.Stein WD, Yang J, Bates SE, Fojo T. Bevacizumab reduces the growth rate constants of renal carcinomas: a novel algorithm suggests early discontinuation of bevacizumab resulted in a lack of survival advantage. The oncologist. 2008;13(10):1055-62. Epub 2008/10/02. doi: 10.1634/theoncologist.2008-0016. PubMed PMID: 18827177.  
43.Stein WD, Wilkerson J, Kim ST, Huang X, Fojo AT, Motzer RJ, et al. Analyzing the pivotal trial that compared sunitinib and interferon alfa in renal cell carcinoma, using a method that assesses tumor regression and growth. Clin Cancer Res. 2012. Epub 2012/02/22. doi: 10780432.CCR-11-2275 [pii] 10.1158/1078-0432.CCR-11-2275. PubMed PMID: 22344231.  
44.Stein WD, Gulley JL, Schlom J, Madan RA, Dahut W, Figg WD, et al. Tumor regression and growth rates determined in five intramural NCI prostate cancer trials: the growth rate constant as an indicator of therapeutic efficacy. Clinical cancer research: an official journal of the American Association for Cancer Research. 2011;17(4):907-17. Epub 2010/11/26. doi: 10.1158/1078-0432.CCR-10-1762. PubMed PMID: 21106727.  
45.DiPaola RS, Chen Y, Bubley GJ, Hahn NM, Stein M, Schlom J, et al., editors. A phase II
study of PROSTVAC-V (vaccinia)/TRICOM and PROSTVAC-F (fowlpox)/TRICOM with GM-CSF in patients with PSA progression after local therapy for prostate cancer: Results of ECOG 9802. Genitourinary Cancers Symposium 2009.  
46.Beer TM, Bernstein GT, Corman JM, Glode LM, Hall SJ, Poll WL, et al. Randomized trial of autologous cellular immunotherapy with sipuleucel-T in androgen-dependent prostate cancer. Clin Cancer Res. 2011;17(13):4558-67. Epub 2011/05/12. doi: 1078-0432.CCR-10-3223 [pii] 10.1158/1078-0432.CCR-10-3223. PubMed PMID: 21558406.  
47.Arlen PM, Gulley JL, Palena C, Marshall J, Schlom J, Tsang KY. A novel ELISPOT assay to enhance detection of antigen-specific T cells employing antigen-presenting cells expressing vector-driven human B7-1. J Immunol Methods. 2003;279(1-2):183-92. Epub 2003/09/13. doi: S0022175903001856 [pii]. PubMed PMID: 12969559.  
48.Arlen P, Tsang KY, Marshall JL, Chen A, Steinberg SM, Poole D, Horan Hand P, Schlom J,
and Hamilton JM. The use of a rapid ELISPOT assay to analyze peptide-specific immune responses in carcinoma patients to peptide vs. recombinant poxvirus vaccines. *Cancer* Immunol. Immunother. 49: 517-529, 2000.  
49.Crook JM, O'Callaghan CJ, Duncan G, et al. Intermitten androgen suppression for rising PSA
level after radiotherapy. N Engl J Med. 367: 895-903, 2012.  
50.Tombal, B., et al., Enzalutamide monotherapy in hormone-naive prostate cancer: primary analysis of an open-label, single-arm, phase 2 study. Lancet Oncol, 2014. 15(6): p. 592-600.
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13 appendix a performance status

| ECOG Performance Status Scale                                                                                                                                                  | Karnofsky Performance Scale                                   |                                                                           |                                                                        |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------------------|------------------------------------------------------------------------|
| Grade                                                                                                                                                                          | Descriptions                                                  | Percent                                                                   | Descriptions                                                           |
| 100                                                                                                                                                                            | Normal, no complaints, no evidence  of disease.               |                                                                           |                                                                        |
| Normal activity. Fully active, able                                                                                                                                            |                                                               |                                                                           |                                                                        |
| 0                                                                                                                                                                              | to carry on all pre-disease  performance without restriction. | 90                                                                        | Able to carry on normal activity;  minor signs or symptoms of disease. |
| Symptoms, but ambulatory.  Restricted in physically strenuous  activity, but ambulatory and able  to carry out light or sedentary  work (e.g., light housework, office  work). | 80                                                            | Normal activity with effort; some  signs or symptoms of disease.          |                                                                        |
| 1                                                                                                                                                                              | 70                                                            | Cares for self, unable to carry on  normal activity or to do active work. |                                                                        |
| In bed < 50% of the time.  Ambulatory and capable of all  self-care, but unable to carry out  any work activities. Up and about  > 50% of waking hours.                        | Requires occasional assistance, but                           |                                                                           |                                                                        |
| 60                                                                                                                                                                             | is able to care for most of his/her  needs.                   |                                                                           |                                                                        |
| 2                                                                                                                                                                              | 50                                                            | Requires considerable assistance and  frequent medical care.              |                                                                        |
| In bed > 50% of the time. Capable  of only limited self-care, confined  to bed or chair > 50% of waking  hours.                                                                | 40                                                            | Disabled, requires special care and  assistance.                          |                                                                        |
| 3                                                                                                                                                                              | 30                                                            | Severely disabled, hospitalization  indicated. Death not imminent.        |                                                                        |
| 100% bedridden. Completely  disabled. Cannot carry on any selfcare. Totally confined to bed or  chair.                                                                                                                                                                                | 20                                                            | Very sick, hospitalization indicated.  Death not imminent.                |                                                                        |
| 4                                                                                                                                                                              | 10                                                            | Moribund, fatal processes  progressing rapidly.                           |                                                                        |
| 5                                                                                                                                                                              | Dead.                                                         | 0                                                                         | Dead.                                                                  |
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14 appendix b vaccinia-psa(l155)/tricom patient

1. What vaccination site reactions can you expect? 2. How should you care for the vaccination site? 3. Are there any activities I should avoid? 4. What about contact with other people? 5. Who do I contact when I have a question?
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1. what vaccination site reactions

A typical reaction in a patient who has been previously vaccinated with vaccinia includes the appearance of a small swelling in 2-3 days that may enlarge to 1-2 inches across, a small blister or pustule after 5-7 days, and healing with little scarring within 2-3 weeks. Some patients may have very little skin reaction. Often the leg that received the vaccine may become swollen. Swollen or tender lymph nodes ("glands") in the groin may be felt. A fever to 100-101qF may occur on the second or third day. You may notice that you feel tired for 3 or 4 days. The vaccination site may itch for about 2 weeks while the scab is forming. You can take acetaminophen ("Tylenol") if you have any aches or fever but should avoid aspirin. If fever continues for more than a day or two, you should call to speak to the clinic nurse or the research nurse. In patients who have never received vaccinia or in some who received it a very long time ago, a red swelling is followed by a blisters on day 5 to 6 and then formation of a pustule (or "boil") 1-2 inches in diameter on day 9 to 11. A large area of redness may surround this area. A crusted scab usually forms by the second week and falls off by the third week leaving a scar roughly 1/2 inch in diameter. Fever and malaise (the "blahs") may occur during the blister and pustular phases. Swollen and tender lymph nodes may persist for months. Many of the local toxicities described (e.g., pustule and scab formation) are typical of reactions seen when vaccinia is administered via scarification or intradermal administration. These reactions may be seen, but are usually not seen when administered via subcutaneous injection.
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2. how should you care

Live vaccinia virus is in skin cells at the vaccination site during the 1-2 weeks until healing has occurred. Maximal viral "shedding" from the vaccination site occurs from days 4-14, but can continue until the scab falls off from the skin. After that there is no vaccinia virus in your body. You can spread the virus to other parts of your body or to other people by touching the vaccination site and then touching your eyes, mouth, a cut or some other break in the skin. You do not pass vaccinia virus by coughing or sneezing or by sharing food or cups and dishes. In general, frequent careful hand washing by you and by any persons in physical contact with you is the best way to prevent transmission of virus. You should also use two types of barriers over your vaccination site at all times until the scab is gone. These barriers are (1) the bandage and (2) clothing (pants or elbow length sleeves depending on the site of vaccination). These barriers should remain in place until the scab has fallen off. For dressing care you will have a bag with some no-stick "First-Aid" or "Telfa" pads, disposable gloves, and zip-lock plastic bags. If you run out of supplies between visits, you can use a dry sterile bandage (gauze or "First-Aid" or "Telfa") from the drug store. The no-stick pad ("First-Aid" or "Telfa" pad) dressing should be worn until the site has healed. If it remains clean and dry and is not coming off, you do not need to change it. If the dressing gets wet either from drainage from the vaccination or from water when you are showering or if it starts coming off, you should remove it and put on a clean bandage. Wear the gloves when handling the old dressings. Put the old dressing and the gloves in the zip-lock bag, then wash your hands, put on the new bandage, and wash your hands again. You do not need to wear gloves for the new bandage. You do not need to wash the vaccination site, but while the dressing is off, you may wash it lightly with a cloth, soap, and water. If you do wash, blot the site dry with a towel (don't rub), then put the wash cloth and the towel in the laundry. Do not let the shower run on the unbandaged site because live virus could be washed onto other areas on your body. Do not put any steroid cream, medicated creams, or other ointments on the vaccination site. Before you throw away the zip-lock bag with the old dressing and gloves in it, pour a little bleach (about a quarter cup) in the bag to help kill any virus.  
Wash your hands after each step.
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3. are there any activities

You should not go swimming until the vaccination site has healed and you no longer need to wear a bandage on it. If you wear contact lenses, have removable dentures, have a colostomy or any other "open" area on your body that needs daily care, always wash your hands very well before handling your contact lenses, dentures, dressings, etc. Take care of all of these procedures before changing your vaccination dressing.
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4. what about contact with

Remember, frequent careful hand washing by you and by any persons with whom you have physical contact is the best way to prevent transmission of virus. During the time you need to wear a bandage (for 7-14 days after vaccination) there are several kinds of people with whom you should avoid close contact. "Close contact" means that you sleep in the same bed with the person, give the person baths, and/or touch their bare skin to change their clothes (or diapers), apply ointments, or change their bandages. The individuals you should avoid include children < 3years of age; pregnant women or nursing women; individuals with eczema, history of eczema or other skin conditions such as active cases of extensive psoriasis, severe rashes, generalized itching, infections, burns, chicken pox, or skin trauma; and/or immune suppressed individuals such as individuals with leukemia or lymphoma, with AIDS, or those receiving immunosuppressive treatment (for example, after organ transplant).
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5. who do i contact

If you have any questions at any time, please call. A nurse or a physician is available 24 hours a day by telephone. To speak with your main doctor or with a clinic nurse, call the Hematology/Oncology Clinic between 8 AM and 4:30 PM Monday to Friday. To speak with the research nurses, call the research nurse office during the day; during nights, weekends, and sometimes during the day, when the research office is empty, you may leave a message for the research nurse on the answering machine. You can call Dr. Ravi Madan or Dr. James Gulley any time during weekday hours. In an emergency on weekends, evenings, or holidays, you can always get in touch with the MEDICAL ONCOLOGY DOCTOR ON CALL (listed below) The on call doctor will call you back. If you have to go to an emergency room near your home, go to the hospital first, and then have the doctors there call for more information.  
PHONE NUMBERS 3 South East (301) 451-1152  
12th floor Oncology Clinic (301) 496-4026* Ravi Madan, MD (301) 480-7168* James Gulley, MD, PhD (301) 480-7164*  
*after clinic hours the NCI Medical Oncology physician On call through NIH page operator (301) 496-1211
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15 appendix c on study

| Arm A (Enzalutamide                                        | Arm B (Enzalutamide + PSATRICOM)                                                                                                                                                                                                                                                                                                                                                                                                                   |                                                                                                                                                                                                                                                                                                                                                                                                                               |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| only)                                                      |                                                                                                                                                                                                                                                                                                                                                                                                                   |                                                                                                                                                                                                                                                                                                                                                                                                                               |
| Prior to Enrollment                                        | Screening for eligibility,  Informed consent, NIH  Advanced Directives Form1                                                                                                                                                                                                                                                                                                                                      | Screening for eligibility, Informed  consent, NIH Advanced Directives  form1                                                                                                                                                                                                                                                                                                                                                  |
| Within 8 weeks of                                          | *Apheresis, Lab work (HIV,                                                                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                                                                                                                                                                                                                                                                                               |
| initiating treatment                                       | Hep B and C), baseline scans  (MRI/CT and bone scans), EKG                                                                                                                                                                                                                                                                                                                                                        | *Apheresis, Lab work (HIV, Hep B  and C), baseline scans (MRI/CT and  bone scans), EKG                                                                                                                                                                                                                                                                                                                                        |
| Within 16 days of  beginning treatment  (day -16 to day 1) | Baseline history and physical  exam, ECOG status, Research  Blood, CBC, Acute, Hepatic,  Mineral Panels, LDH, CK,  Uric Acid, Total Protein,  TBNK, PSA, testosterone, PAP (prostatic acid  phosphatase), dihydrotestosterone (DHT), sex hormone-binding globulin  (SHBG),  dehydroepiandrosterone  (DHEA), luteinizing hormone  (LH), follicle-stimulating  hormone (FSH),  androstenedione prolactin, estradiol | Baseline history and physical exam,  ECOG status, Research Blood, CBC,  Acute, Hepatic, Mineral Panels,  LDH, CK, Uric Acid, Total Protein,  TBNK, PSA, testosterone, PAP  (prostatic acid phosphatase), dihydrotestosterone (DHT), sex hormone-binding globulin  (SHBG), dehydroepiandrosterone  (DHEA), luteinizing hormone (LH),  follicle-stimulating hormone (FSH),  androstenedione prolactin, estradiol  Randomization |
| Randomization                                              |                                                                                                                                                                                                                                                                                                                                                                                                                   |                                                                                                                                                                                                                                                                                                                                                                                                                               |
| Day 1                                                      | Enzalutamide day 1 month 1                                                                                                                                                                                                                                                                                                                                                                                        | Enzalutamide day 1 month 1 +                                                                                                                                                                                                                                                                                                                                                                                                  |
| (daily dose of 160 mg)                                     | PSA-TRICOM (Prostvac-V) dose 1                                                                                                                                                                                                                                                                                                                                                                                    |                                                                                                                                                                                                                                                                                                                                                                                                                               |
| Week 3                                                     | Physical examination Research Blood, CBC, Acute,  Hepatic, Mineral Panels, LDH,  CK, Uric Acid, Total Protein,                                                                                                                                                                                                                                                                                                    | Physical examination Research Blood, CBC, Acute,  Hepatic, Mineral Panels, LDH, CK,  Uric Acid, Total Protein,                                                                                                                                                                                                                                                                                                                |  
| Arm A (Enzalutamide                                                                                                                                                                                                                         | Arm B (Enzalutamide + PSATRICOM)                                                                                                                                                                                                                                                                                                                                                      |                                                                                                                                                                                                                                                                                                                                                                                                                  |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| only) TBNK, PSA, testosterone, PAP, dihydrotestosterone (DHT), sex hormone-binding globulin  (SHBG),  dehydroepiandrosterone  (DHEA), luteinizing hormone  (LH), follicle-stimulating  hormone (FSH),  androstenedione prolactin, estradiol | TBNK, PSA, testosterone, PAP, dihydrotestosterone (DHT), sex hormone-binding globulin  (SHBG), dehydroepiandrosterone  (DHEA), luteinizing hormone (LH),  follicle-stimulating hormone (FSH),  androstenedione prolactin, estradiol  PSA-TRICOM (Prostvac-F) dose 1                                                                                  |                                                                                                                                                                                                                                                                                                                                                                                                                  |
| Week 5                                                                                                                                                                                                                                      | Physical examination Research Blood, CBC, Acute,  Hepatic, Mineral Panels, LDH,  CK, Uric Acid, Total Protein, TBNK, PSA, testosterone, PAP, dihydrotestosterone (DHT), sex hormone-binding globulin  (SHBG),  dehydroepiandrosterone  (DHEA), luteinizing hormone  (LH), follicle-stimulating  hormone (FSH),  androstenedione prolactin, estradiol | Physical examination Research Blood, CBC, Acute,  Hepatic, Mineral Panels, LDH, CK,  Uric Acid, Total Protein, TBNK, PSA, testosterone, PAP, dihydrotestosterone (DHT), sex hormone-binding globulin  (SHBG), dehydroepiandrosterone  (DHEA), luteinizing hormone (LH),  follicle-stimulating hormone (FSH),  androstenedione prolactin, estradiol  Enzalutamide day 1 month 2 +  PSA-TRICOM (Prostvac-F) dose 2 |
| Enzalutamide day 1 month 2 (daily dose of 160 mg)                                                                                                                                                                                           |                                                                                                                                                                                                                                                                                                                                                      |                                                                                                                                                                                                                                                                                                                                                                                                                  |
| Week 9                                                                                                                                                                                                                                      | Physical examination , CBC, Acute, Hepatic,  Mineral Panels, LDH, CK,  Uric Acid, Total Protein, TBNK, PSA, testosterone, PAP, dihydrotestosterone  (DHT), sex hormone-binding  globulin (SHBG),  dehydroepiandrosterone  (DHEA), luteinizing hormone  (LH), follicle-stimulating  hormone (FSH),  androstenedione                                   | Physical examination , CBC, Acute, Hepatic, Mineral  Panels, LDH, CK, Uric Acid, Total  Protein, TBNK, PSA, testosterone, PAP, dihydrotestosterone (DHT), sex hormone-binding globulin  (SHBG), dehydroepiandrosterone  (DHEA), luteinizing hormone (LH),  follicle-stimulating hormone (FSH),  androstenedione prolactin, estradiol                                                                             |  
| Arm A (Enzalutamide                                                          | Arm B (Enzalutamide + PSATRICOM)                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                                                                                                                                                                                                                                                                                       |
|------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| only) prolactin, estradiol Enzalutamide day 1 month 3 (daily dose of 160 mg) | Enzalutamide day 1 month 3 +  PSA-TRICOM (Prostvac-F) dose 3                                                                                                                                                                                                                                                                           |                                                                                                                                                                                                                                                                                                                                                                                                                       |
| Week 13                                                                      | Physical examination , CBC, Acute, Hepatic,  Mineral Panels, LDH, CK,  Uric Acid, Total Protein, TBNK, PSA, testosterone, PAP, dihydrotestosterone (DHT), sex hormone-binding globulin  (SHBG),  dehydroepiandrosterone  (DHEA), luteinizing hormone  (LH), follicle-stimulating  hormone (FSH),  androstenedione prolactin, estradiol | Physical examination , CBC, Acute, Hepatic, Mineral  Panels, LDH, CK, Uric Acid, Total  Protein, TBNK, PSA, testosterone, PAP, dihydrotestosterone (DHT), sex hormone-binding globulin  (SHBG), dehydroepiandrosterone  (DHEA), luteinizing hormone (LH),  follicle-stimulating hormone (FSH),  androstenedione prolactin, estradiol  *Apheresis Enzalutamide therapy is  discontinued PSA-TRICOM (Prostvac-F) dose 4 |
| *Apheresis Enzalutamide therapy is  discontinued                             |                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                                                                                                                                                                                                                                                                                       |
| Week 15                                                                      | , CBC, Acute, Hepatic,  Mineral Panels, LDH, CK,  Uric Acid, Total Protein, TBNK, PSA, testosterone, PAP, dihydrotestosterone (DHT), sex hormone-binding globulin  (SHBG),  dehydroepiandrosterone  (DHEA), luteinizing hormone  (LH), follicle-stimulating  hormone (FSH),  androstenedione prolactin, estradiol                      | , CBC, Acute, Hepatic, Mineral  Panels, LDH, CK, Uric Acid, Total  Protein, TBNK, PSA, testosterone, PAP, dihydrotestosterone (DHT), sex hormone-binding globulin  (SHBG), dehydroepiandrosterone  (DHEA), luteinizing hormone (LH),  follicle-stimulating hormone (FSH),  androstenedione prolactin, estradiol                                                                                                       |  
| Arm A (Enzalutamide   | Arm B (Enzalutamide + PSATRICOM)                                                                                                                                                                                                                                                                                                                                                      |                                                                                                                                                                                                                                                                                                                                                                                    |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| only)                 |                                                                                                                                                                                                                                                                                                                                                      |                                                                                                                                                                                                                                                                                                                                                                                    |
| Week 17               | Physical examination Research Blood, CBC, Acute,  Hepatic, Mineral Panels, LDH,  CK, Uric Acid, Total Protein, TBNK, PSA, testosterone, PAP, dihydrotestosterone (DHT), sex hormone-binding globulin  (SHBG),  dehydroepiandrosterone  (DHEA), luteinizing hormone  (LH), follicle-stimulating  hormone (FSH),  androstenedione prolactin, estradiol | Physical examination Research Blood, CBC, Acute,  Hepatic, Mineral Panels, LDH, CK,  Uric Acid, Total Protein, TBNK, PSA, testosterone, PAP, dihydrotestosterone (DHT), sex hormone-binding globulin  (SHBG), dehydroepiandrosterone  (DHEA), luteinizing hormone (LH),  follicle-stimulating hormone (FSH),  androstenedione prolactin, estradiol  PSA-TRICOM (Prostvac-F) dose 5 |
| Week 21               | Physical examination , CBC, Acute, Hepatic,  Mineral Panels, LDH, CK,  Uric Acid, Total Protein, TBNK, PSA, testosterone, PAP, dihydrotestosterone (DHT), sex hormone-binding globulin  (SHBG),  dehydroepiandrosterone  (DHEA), luteinizing hormone  (LH), follicle-stimulating  hormone (FSH),  androstenedione prolactin, estradiol               | Physical examination , CBC, Acute, Hepatic, Mineral  Panels, LDH, CK, Uric Acid, Total  Protein, TBNK, PSA, testosterone, PAP dihydrotestosterone (DHT), sex hormone-binding globulin  (SHBG), dehydroepiandrosterone  (DHEA), luteinizing hormone (LH),  follicle-stimulating hormone (FSH),  androstenedione prolactin, estradiol  PSA-TRICOM (Prostvac-F) dose 6                |
| Week 25               | Physical examination , CBC, Acute, Hepatic,  Mineral Panels, LDH, CK,  Uric Acid, Total Protein, TBNK, PSA, testosterone, PAP, dihydrotestosterone (DHT), sex hormone-binding globulin  (SHBG),  dehydroepiandrosterone                                                                                                                              | Physical examination , CBC, Acute, Hepatic, Mineral  Panels, LDH, CK, Uric Acid, Total  Protein, TBNK, PSA, testosterone, PAP, dihydrotestosterone (DHT), sex hormone-binding globulin  (SHBG), dehydroepiandrosterone  (DHEA), luteinizing hormone (LH),                                                                                                                          |  
| Arm A (Enzalutamide                                                                                                            | Arm B (Enzalutamide + PSATRICOM)                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                                                                                                                                                                                                      |
|--------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| only) (DHEA), luteinizing hormone  (LH), follicle-stimulating  hormone (FSH),  androstenedione prolactin, estradiol *Apheresis | follicle-stimulating hormone (FSH),  androstenedione prolactin, estradiol  *Apheresis PSA-TRICOM (Prostvac-F) is  discontinued                                                                                                                                                                                                         |                                                                                                                                                                                                                                                                                                                                      |
| Week 29                                                                                                                        | Physical examination , CBC, Acute, Hepatic,  Mineral Panels, LDH, CK,  Uric Acid, Total Protein, TBNK, PSA, testosterone, PAP, dihydrotestosterone (DHT), sex hormone-binding globulin  (SHBG),  dehydroepiandrosterone  (DHEA), luteinizing hormone  (LH), follicle-stimulating  hormone (FSH),  androstenedione prolactin, estradiol | Physical examination , CBC, Acute, Hepatic, Mineral  Panels, LDH, CK, Uric Acid, Total  Protein, TBNK, PSA, testosterone, PAP, dihydrotestosterone (DHT), sex hormone-binding globulin  (SHBG), dehydroepiandrosterone  (DHEA), luteinizing hormone (LH),  follicle-stimulating hormone (FSH),  androstenedione prolactin, estradiol |
| Up to Week 52                                                                                                                  | Physical examination                                                                                                                                                                                                                                                                                                                   |                                                                                                                                                                                                                                                                                                                                      |
| Every 4 weeks **                                                                                                               | , CBC, Acute, Hepatic,  Mineral Panels, LDH, CK,  Uric Acid, Total Protein, TBNK, PSA, testosterone,  PAP, dihydrotestosterone (DHT), sex hormone-binding globulin  (SHBG),  dehydroepiandrosterone  (DHEA), luteinizing hormone  (LH), follicle-stimulating  hormone (FSH),  androstenedione prolactin, estradiol                     | Physical examination , CBC, Acute, Hepatic, Mineral  Panels, LDH, CK, Uric Acid, Total Protein, TBNK, PSA, testosterone, PAP, dihydrotestosterone (DHT), sex hormone-binding globulin  (SHBG), dehydroepiandrosterone  (DHEA), luteinizing hormone (LH),  follicle-stimulating hormone (FSH),  androstenedione prolactin, estradiol  |
| Research Blood (week 52  only)                                                                                                 | Research Blood (week 52 only)                                                                                                                                                                                                                                                                                                          |                                                                                                                                                                                                                                                                                                                                      |  
| Arm A (Enzalutamide                         | Arm B (Enzalutamide + PSATRICOM)                                                                                                                                                                                                                                                                                                                                         |                                                                                                                                                                                                                                                                                                                                                   |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| only)                                       |                                                                                                                                                                                                                                                                                                                                         |                                                                                                                                                                                                                                                                                                                                                   |
| Beyond Week 52 Every 8 weeks (+/- 7 days)** | Physical examination , CBC, Acute, Hepatic,  Mineral Panels, LDH, CK,  Uric Acid, Total Protein, TBNK, PSA, testosterone,  PAP, dihydrotestosterone (DHT), sex hormone-binding globulin  (SHBG),  dehydroepiandrosterone  (DHEA), luteinizing hormone  (LH), follicle-stimulating  hormone (FSH),  androstenedione prolactin, estradiol | Physical examination , CBC, Acute, Hepatic, Mineral  Panels, LDH, CK, Uric Acid, Total  Protein, TBNK, PSA, testosterone, PAP, dihydrotestosterone (DHT), sex hormone-binding globulin  (SHBG), dehydroepiandrosterone  (DHEA), luteinizing hormone (LH),  follicle-stimulating hormone (FSH),  androstenedione prolactin, estradiol              |
| Research Blood (every 16  weeks)            | Research Blood (every 16 weeks)                                                                                                                                                                                                                                                                                                         |                                                                                                                                                                                                                                                                                                                                                   |
| Once PSA reaches                            | Restaging Scans (MRI/CT and                                                                                                                                                                                                                                                                                                             | Restaging scans (MRI/CT and bone                                                                                                                                                                                                                                                                                                                  |
| baseline value                              | bone scans)                                                                                                                                                                                                                                                                                                                             | scans)                                                                                                                                                                                                                                                                                                                                            |
| Course 2, Week 1                            | Enzalutamide day 1 month 1, course 2 (daily dose of 160 mg)                                                                                                                                                                                                                                                                             | Enzalutamide day 1 month 1, course  2                                                                                                                                                                                                                                                                                                             |
| Research labs including  plasma VEGF levels | Research labs including plasma  VEGF levels                                                                                                                                                                                                                                                                                             |                                                                                                                                                                                                                                                                                                                                                   |
| Course 2,Week 5                             | Physical examination Research Blood, CBC, Acute,  Hepatic, Mineral Panels, LDH,  CK, Uric Acid, Total Protein, TBNK, PSA, testosterone,  PAP, dihydrotestosterone (DHT), sex hormone-binding globulin  (SHBG),  dehydroepiandrosterone  (DHEA), luteinizing hormone  (LH), follicle-stimulating                                         | Physical examination Research Blood, CBC, Acute,  Hepatic, Mineral Panels, LDH, CK,  Uric Acid, Total Protein, TBNK, PSA, testosterone, PAP, dihydrotestosterone (DHT), sex hormone-binding globulin  (SHBG), dehydroepiandrosterone  (DHEA), luteinizing hormone (LH), follicle-stimulating hormone (FSH),  androstenedione prolactin, estradiol |  
| Arm A (Enzalutamide                                        | Arm B (Enzalutamide + PSATRICOM)                                                                                                                                                                                                                                                                                                                                                       |                                                                                                                                                                                                                                                                                                                                                                                                |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| only) hormone  (FSH)androstenedione prolactin, estradiol   | Enzalutamide day 1 month 2 course 2                                                                                                                                                                                                                                                                                                                   |                                                                                                                                                                                                                                                                                                                                                                                                |
| Enzalutamide day 1 month 2 course 2 (daily dose of 160 mg) |                                                                                                                                                                                                                                                                                                                                                       |                                                                                                                                                                                                                                                                                                                                                                                                |
| Course 2, Week 9                                           | Physical examination , CBC, Acute, Hepatic,  Mineral Panels, LDH, CK,  Uric Acid, Total Protein, TBNK, PSA, testosterone,  PAP, dihydrotestosterone (DHT), sex hormone-binding globulin  (SHBG),  dehydroepiandrosterone  (DHEA), luteinizing hormone  (LH), follicle-stimulating  hormone (FSH),  androstenedione prolactin, estradiol               | Physical examination , CBC, Acute, Hepatic, Mineral  Panels, LDH, CK, Uric Acid, Total  Protein, TBNK, PSA, testosterone, PAP, dihydrotestosterone (DHT), sex hormone-binding globulin  (SHBG), dehydroepiandrosterone  (DHEA), luteinizing hormone (LH),  follicle-stimulating hormone (FSH),  androstenedione prolactin, estradiol Enzalutamide day 1 month 3 course 2                       |
| Enzalutamide day 1 month 3 course 2 (daily dose of 160 mg) |                                                                                                                                                                                                                                                                                                                                                       |                                                                                                                                                                                                                                                                                                                                                                                                |
| Course 2, Week 13                                          | Physical examination Research Blood, CBC, Acute,  Hepatic, Mineral Panels, LDH,  CK, Uric Acid, Total Protein, TBNK, PSA, testosterone,  PAP, dihydrotestosterone (DHT), sex hormone-binding globulin  (SHBG),  dehydroepiandrosterone  (DHEA), luteinizing hormone  (LH), follicle-stimulating  hormone (FSH),  androstenedione prolactin, estradiol | Physical examination Research Blood, CBC, Acute,  Hepatic, Mineral Panels, LDH, CK,  Uric Acid, Total Protein, TBNK, PSA, testosterone, PAP, dihydrotestosterone (DHT), sex hormone-binding globulin  (SHBG), dehydroepiandrosterone  (DHEA), luteinizing hormone (LH),  follicle-stimulating hormone (FSH),  androstenedione prolactin, estradiol Research labs including plasma  VEGF levels |  
| Arm A (Enzalutamide                                           | Arm B (Enzalutamide + PSATRICOM)                                                                                                                                                                                                                                                                                                                     |                                                                                                                                                                                                                                                                                                                                       |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| only) Research labs including  plasma VEGF levels             | *Apheresis Enzalutamide therapy is discontinued for course 2                                                                                                                                                                                                                                                        |                                                                                                                                                                                                                                                                                                                                       |
| *Apheresis Enzalutamide therapy is  discontinued for course 2 |                                                                                                                                                                                                                                                                                                                     |                                                                                                                                                                                                                                                                                                                                       |
| Every 4 weeks                                                 | Physical examination                                                                                                                                                                                                                                                                                                |                                                                                                                                                                                                                                                                                                                                       |
| thereafter                                                    | , CBC, Acute, Hepatic,  Mineral Panels, LDH, CK,  Uric Acid, Total Protein,  TBNK, PSA, testosterone,  PAP, dihydrotestosterone (DHT), sex hormone-binding globulin  (SHBG),  dehydroepiandrosterone  (DHEA), luteinizing hormone  (LH), follicle-stimulating  hormone (FSH),  androstenedione prolactin, estradiol | Physical examination , CBC, Acute, Hepatic, Mineral  Panels, LDH, CK, Uric Acid, Total  Protein, TBNK, PSA, testosterone,  PAP, dihydrotestosterone (DHT), sex hormone-binding globulin  (SHBG), dehydroepiandrosterone  (DHEA), luteinizing hormone (LH),  follicle-stimulating hormone (FSH),  androstenedione prolactin, estradiol |
| Research Blood (every 16  weeks)                              | Research Blood (every 16 weeks)                                                                                                                                                                                                                                                                                     |                                                                                                                                                                                                                                                                                                                                       |  
*Apheresis is not mandatory and will be scheduled based on availability -Patients may come off study before week 52 as clinically indicated. -All patient visits can be delayed by 1 week for logistical issues. ** Patients will be followed until PSA reaches baseline. Patients who continue to be followed for rising PSA but have not required ADT may be seen beyond the study period. The study period ends 52 weeks after enrollment unless patients receive a second course of enzalutamide, then study period ends 9 months after the end of the second course.  
1 As indicated in section 7.3, all subjects will be offered the opportunity to complete an NIH advanced directives form. This should be done preferably at baseline but can be done at any time during the study as long as the capacity to do so is retained. The completion of the form is strongly recommended, but is not required.
untitled h1
16 appendix d instructions for

| Blood Studies                                                                       | Blood Tube/Comments                                         | Destination                                   |
|-------------------------------------------------------------------------------------|-------------------------------------------------------------|-----------------------------------------------|
| CBC with differential                                                               | 1 light lavender tube                                       | CC Department of  Laboratory Medicine (DLM)   |
| Hepatic Panel, Mineral Panel,  Acute Care Panel, LDH, CK,  Uric Acid, Total Protein | 1 4 mL SST                                                  | CC DLM                                        |
| Anti-HIV-1/2                                                                        | 1 8 mL SST                                                  | CC TTV lab                                    |
| Testosterone, total                                                                 | 1 red top tube                                              | CC DLM                                        |
| Prostate Specific Antigen                                                           | 4 mL SST                                                    | CC DLM                                        |
| Lymphocyte Phenotyping,                                                             | 1 light lavender tube                                       | CC DLM                                        |
| TBNK Immunology Assays                                                              | 6 10 mL Na Heparin tubes 2 7 ml SST tubes Apheresis Product | NCI-Frederick 1-301-846-5893                  |
| Serum VEGF                                                                          | 6mL EDTA tube                                               | Dr. Figg's lab - Blood  Processing Core (BPC) |