J1265: A neoadjuvant immunologic study of androgen deprivation therapy combined with a GM -CSF–secreting allogeneic prostate cancer vaccine and low - dose cyclophosphamide in men with high -risk localized prostate cancer undergoing radical prostatectomy NCT01696877 Protocol Date: November 30, 2012 Principal Investigator: Emmanuel S. Antonarakis, MD Androgen suppression with prostate GVAX and cyclophosphamide J1265 Johns Hopkins University 1 of 68 J1265 PROT (Vers) 1.4 113012 A neoadjuvant immunologic study of androgen deprivation therapy combined with a GM -CSF –secreting allogeneic prostate cancer vaccine and low -dose cyclophosph amide in men with high -risk localized prostate cancer undergoing radical prostatectomy IRB #: NA_00073453 IND #: 9678 Johns Hopkins University Principal Investigator Statistician Emmanuel S . Antonarakis, MD (Protocol Author) Marianna Zahurak, MS The Bunting -Blaustein Cancer Research Building 1650 Orleans Street, CRB1 - Room 1M45 Baltimore, MD 21231 Phone: (443) 287 -0553 Fax: (410) 614 -8397 Johns Hopkins Oncology Biostatistics 550 North Broadway, Suite 1103 Baltimore, MD 21205 Phone: (410) 955 -4219 Fax: (410) 955 -0859 Email: eantona1@jhmi.edu Email: zahurma@jhmi.edu Co-Principal Investigator Study Coordinator Edward M. Schaeffer, MD, PhD Haiyi Cao The Bunting -Blaustein Cancer Research Building 1650 Orleans Street, CRB2 – Room 5M43 Baltimore, MD 21231 Phone: (410) 502 -2733 Fax: (410) 614 -0549 550 North Broadway Suite 827 Baltimore, MD 21205 Phone: (443) 287 -6882 Fax: (410) 614 -7287 Email: eschaef4 @jhmi.edu Email: hcao7@jhmi.edu Co-Investigator s Charles Drake , MD , PhD (cdrake@jhmi.edu ) Michael Carducci, MD (carducci@jhmi.edu ) Mario Eisenberger, MD ( eisenma@jhmi.edu ) Samuel Denmeade, MD ( denmesa@jhmi.edu ) Hans Hammers, MD, PhD ( hhammer2@jhmi.edu ) Jenny Kim, MD ( jkim366@jhmi.edu ) Janet Walczak, CRNP ( walczja@jhmi.edu ) Victoria Sinibaldi, CRNP ( sinibvi@jhmi.edu ) Misop Han , MD (mhan1@jhmi.edu ) Alan Partin, MD, PhD ( apartin2@jhmi.edu ) Mohamad Allaf, MD ( mallaf @jhmi.edu ) Gary Rosner, PhD ( grosner1@jhmi.edu ) Donna Dowling, RN ( ddowlin1@jhmi.edu ) Monica Taylor, RN ( mtaylo27@jhmi.edu ) Caroline Pratz, CRNP ( fidykca@jhmi.edu ) Robin Gurganus, RN ( rgurgan1@jhmi.edu ) George Netto, MD ( gnetto1@jhmi.edu ) Jennifer Uram, PhD ( juram1@jhmi.edu ) Connie Collins, RN ( ccolli23@jhmi.edu ) Rana Sullivan, RN ( tomalra@jhmi.edu ) Avery Spitz, RN ( aspitz2@jhmi.edu ) Sara So lt (ssolt1@jhmi.edu ) Anthony Wamwea (awamwea1@jhmi.edu ) Protocol Date: November 30, 2012 Protocol Type / Version # / Version Date: Protocol / Version 1. 4 / November 30, 2012 Androgen suppression with prostate GVAX and cyclophosphamide J1265 Johns Hopkins University 2 of 68 J1265 PROT (Vers) 1.4 113012 CONFIDENTIALITY STATEMENT The information in this document is provided to you as an investigator, potential investigator, consultant, or contractor, for review by you, your staff, and the appropriate Institutional Revie w Board or Ethics Committee.