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 betw een 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 NUMBERS3 South East (301) 451-1152 12 thfloor 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 pageoperator (301) 496-1211 Version Date: 12/5/17 Abbreviated Title : Enzalutamide in non-met CSPC 8015 APPENDIX C : ON STUDY AND FOLLOW-UP EVALUATIONS COHORT 1 Arm A (Enzalutamide only)Arm B (Enzalutamide + PSA- TRICOM) Prior to Enrollment Screening for eligibility, Informed consent, NIH Advanced Directives Form1Screening for eligibility, Informed consent, NIH Advanced Directives form 1 Within 8 weeks of initiating treatment*Apheresis , Lab work (HIV, 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), androstenedioneprolactin, estradiol RandomizationBaseline 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), androstenedioneprolactin, estradiol Randomization Day 1 Enzalutamide day 1 month 1 (daily dose of 160 mg)Enzalutamide day 1 month 1 + 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 Pa nels, LDH, CK, Uric Acid, Total Protein, Version Date: 12/5/17 Abbreviated Title : Enzalutamide in non-met CSPC 81Arm A (Enzalutamide only)Arm B (Enzalutamide + PSA- TRICOM) TBNK, PSA, testosterone, PAP,dihydrotestosterone (DHT),sex hormone-binding globulin (SHBG), dehydroepiandrosterone (DHEA), luteinizing hormone (LH), follicle-stimulating hormone (FSH), androstenedioneprolactin, estradiol TBNK, PSA, testosterone, PAP,dihydrotestosterone (DHT),sex hormone-binding globulin (SHBG), dehydroepiandrosterone (DHEA), luteinizing hormone (LH), follicle-stimulating hormone (FSH), androstenedioneprolactin, 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), androstenedioneprolactin, estradiol Enzalutamide day 1 month 2 (daily dose of 160 mg)Physical examination Research Blood, CBC, Acute, Hepatic, Mineral Pa nels, 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), androstenedioneprolactin, estradiol Enzalutamide day 1 month 2 + PSA-TRICOM (Prostvac-F) dose 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), androstenedionePhysical 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), androstenedioneprolactin, estradiol Version Date: 12/5/17 Abbreviated Title : Enzalutamide in non-met CSPC 82Arm A (Enzalutamide only)Arm B (Enzalutamide + PSA- TRICOM) 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), androstenedioneprolactin, estradiol *Apheresis Enzalutamide therapy is discontinuedPhysical 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), androstenedioneprolactin, estradiol *Apheresis Enzalutamide therapy is discontinued PSA-TRICOM (Prostvac-F) dose 4 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), androstenedioneprolactin, 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), androstenedioneprolactin, estradiol Version Date: 12/5/17 Abbreviated Title : Enzalutamide in non-met CSPC 83Arm A (Enzalutamide only)Arm B (Enzalutamide + PSA- TRICOM) 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), androstenedioneprolactin, estradiolPhysical examination Research Blood, CBC, Acute, Hepatic, Mineral Pa nels, 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), androstenedioneprolactin, 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), androstenedioneprolactin, estradiolPhysical examination , CBC, Acute, Hepatic, Mineral Panels, LDH, CK, Uric Acid, Total Protein,TBNK, PSA, testosterone, PAPdihydrotestosterone (DHT),sex hormone-binding globulin (SHBG), dehydroepiandrosterone (DHEA), luteinizing hormone (LH), follicle-stimulating hormone (FSH), androstenedioneprolactin, 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), Version Date: 12/5/17 Abbreviated Title : Enzalutamide in non-met CSPC 84Arm A (Enzalutamide only)Arm B (Enzalutamide + PSA- TRICOM) (DHEA), luteinizing hormone (LH), follicle-stimulating hormone (FSH), androstenedioneprolactin, estradiol *Apheresisfollicle-stimulating hormone (FSH), androstenedioneprolactin, 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), androstenedioneprolactin, estradiolPhysical 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), androstenedioneprolactin, estradiol Up to Week 52 Every 4 weeks **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), androstenedioneprolactin, estradiol Research Blood (week 52 only)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) Version Date: 12/5/17 Abbreviated Title : Enzalutamide in non-met CSPC 85Arm A (Enzalutamide only)Arm B (Enzalutamide + PSA- TRICOM) 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), androstenedioneprolactin, estradiol Research Blood (every 16 weeks)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) Once PSA reaches baseline valueRestaging Scans (MRI/CT and bone scans)Restaging scans (MRI/CT and bone scans) Course 2, Week 1 Enzalutamide day 1 month 1, course 2(daily dose of 160 mg) Research labs including plasma VEGF levelsEnzalutamide day 1 month 1, course 2 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 examinationResearch Blood, CBC, Acute, Hepatic, Mineral Pa nels, 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), androstenedioneprolactin, estradiol Version Date: 12/5/17 Abbreviated Title : Enzalutamide in non-met CSPC 86Arm A (Enzalutamide only)Arm B (Enzalutamide + PSA- TRICOM) hormone (FSH)androstenedioneprolactin, estradiol Enzalutamide day 1 month 2 course 2(daily dose of 160 mg)Enzalutamide day 1 month 2 course 2 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), androstenedioneprolactin, estradiol Enzalutamide day 1 month 3 course 2(daily dose of 160 mg)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), androstenedioneprolactin, estradiol Enzalutamide day 1 month 3 course 2 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), androstenedioneprolactin, estradiolPhysical examinationResearch Blood, CBC, Acute, Hepatic, Mineral Pa nels, 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), androstenedioneprolactin, estradiol Research labs including plasma VEGF levels Version Date: 12/5/17 Abbreviated Title : Enzalutamide in non-met CSPC 87Arm A (Enzalutamide only)Arm B (Enzalutamide + PSA- TRICOM) Research labs including plasma VEGF levels *Apheresis Enzalutamide therapy is discontinued for course 2*ApheresisEnzalutamide therapy is discontinuedfor course 2 Every 4 weeks thereafterPhysical 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), androstenedioneprolactin, estradiol Research Blood (every 16 weeks)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), androstenedioneprolactin, estradiol 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.