Indiana University School of Medicine Thomas A. Gardner, M.D. 535 N. Barnhill Dr. Indianapolis, IN 46202 NAME: Gardner, Thomas EDUCATION: UNDERGRADUATE: The George Washington University Columbian College of Arts and Science Washington, D.C. 1986, B.A. “with Distinction” Major: Computer Science / Statistics GRADUATE: The George Washington University School of Medicine Washington, D.C. 1990, M.D. POSTDOCTORAL: 1990-1991 1991-1992 1992-1995 1993 1992-1996 1995-1996 Intern, General Surgery New York Hospital-Cornell Medical Center, New York, NY Breast and Thoracic Surgery Rotations-Memorial Sloan-Kettering Cancer Center Resident, General Surgery New York Hospital-Cornell Medical Center, New York, NY Thoracic Surgery Rotations-Memorial Sloan-Kettering Cancer Center Resident, Urology New York Hospital-Cornell Medical Center, New York, NY Urologic Surgery Rotation-Memorial Sloan-Kettering Cancer Center Research Rotation New York Hospital-Cornell Medical Center, New York, NY Urologic Oncology Lab (Director: Neil H. Bander) and Male Reproductive Microsurgery & Reconstructive Training Lab (Director Marc Goldstein) Lecturer and Clinical Instructor Cornell University Medical College-Physician Assistant Program, New York,NY Chief Resident, Urology New York Hospital-Cornell Medical Center, New York, NY 1996-1998 Urologic Oncology Research Fellowship Cancer Biology/Gene Therapy Lab Director: Leland W. K. Chung, Ph.D. Department of Urology, Molecular Urology and Therapeutics Program, University of Virginia Health Sciences Center Charlottesville, VA ACADEMIC APPOINTMENTS: (Inclusive dates.) 1998-1999 Assistant Professor of Research Department of Urology, Molecular Urology and Therapeutics Program, University of Virginia Health Sciences Center, Charlottesville, VA P&T Dossier CV 03/2010 Page 1 Thomas A. Gardner, M. D. 1999- 2001 1999-2005 1999 -2005 2005-Present 2005-Present Visiting Assistant Professor Department of Urology, Molecular Urology and Therapeutics Program, University of Virginia Health Sciences Center, Charlottesville, VA Assistant Professor of Urology, Indiana University, School of Medicine Indianapolis, IN Assistant Professor of Microbiology and Immunology Indiana University, School of Medicine Indianapolis, IN Associate Professor of Urology with Tenure, Indiana University, School of Medicine Indianapolis, IN Associate Professor of Microbiology and Immunology Indiana University, School of Medicine Indianapolis, IN HOSPITAL APPOINTMENTS: 1999 – Present Attending Urologist Indiana University Medical Center, Indianapolis, IN 1999 - Present Urology Staff Surgeon and Service Chief (1999-2007) Department of Surgery,Wishard Memorial Hospital, Indianapolis, IN 1999 - Present Urology Staff Surgeon, Department of Surgery VAMC and Methodist Hospital,Clarian North, Clarian West, Indianapolis, IN OTHER APPOINTMENTS AND PROFESSIONAL CONSULTANTSHIPS: DirectGene, Inc., Founder, Scientific Advisory Board, Clinical and Research Consultant (1998 –2003) Advagen, Inc., Scientific Advisory Board (2003-2004) Focus Surgery, Inc., HIFU Proctor, Clinical and Scientific Consultant for SBIR Grant (2001-present) Amgen, Inc., Prostate Cancer Advisory Board Meetings (2000-2001) Pfizer Speaker Bureau (2002-Present) AstraZeneca LP Prostate Cancer Lecture Bureau (2003-Present) Endocare, Inc., Proctor Kidney Cryotherapy (2003-Present) Intuitive Surgery, Proctor Laparoscopic Robotic Surgery (2004-Present) GSK Speaker Bureau (2002 - Present) AMS Proctor (2005-Present) SPECIALTY BOARD STATUS: Diplomate, National Board of Medical Examiners - Part I, II, III Completed 1991 Diplomate, American Board of Urology - Part I 1996, Part II 2002 Recertified - 2009 LICENSURE AND CERTIFICATION: 1991-Present New York State Medical License (In-Active) 1997-Present Virginia State Medical License ( Active) 1999-Present Indiana State Medical License (Active) P&T Dossier CV 03/2010 Page 2 Thomas A. Gardner, M. D. PROFESSIONAL ORGANIZATIONS: American Urological Association - Associate Member Young Urologist Committee –Member North Central Section - Member American Society of Gene Therapy - Member Society of Basic Urologic Research - Member Society of Laparoendoscopic Surgeons - Member Hoosier Oncology Group (HOG) - Member Eastern Cooperative Oncology Group (ECOG) - Member American Medical Association - Member American Association for the Advancement of Science - Member Phi Delta Epsilon Medical Fraternity American Medical Student Association Alpha Epsilon Delta Pre-Medical Honor Society HONORS AND AWARDS: In Rank Intramural Award Total In Rank Extramural Award Total 1982 1982-1986 1995 1996-1998 1996 1997 1998 1999 1999 2000 2000-2002 2002 2004 $2,500 $277,500 Reagents Scholarship-New York Board of Reagents Board of Trustees Honor Scholarship-George Washington University Andlinger Fellowship Award-The American Austrian Foundation American Foundation of Urologic Disease Research Scholar Award CaPCURE Research Award-Co-Investigator (PI-Chung, LWK) CaPCURE Research Award ($100,000) AUA Annual Essay Contest Co-First Prize in Research Category ($ 1,000) CaPCURE Research Award ($100,000) VICAL Best Abstract Award – 1999 Cancer Gene Therapy Meeting ($ 2,500) CaPCURE Research Award ($100,000) NY Academy of Medicine Edwin Beer Award ($ 75,000) AUA Annual Best Video Award – Honorable Mention Indiana University Trustee Teaching Award ($ 2,500) TEACHING ASSIGNMENTS SINCE APPOINTMENT Formal Course Instruction: Medical Students Course Number X601 L700 P&T Dossier CV 03/2010 Course Information Introductions to Clinical Medicine- II - Urology Section Sophomore Lecture (100 students) Series in Urology Role – Urology Section Director and Lecturer, I organize 4 lectures per year (2 hours), Write Exam Questions Organize the Didactic Examination of Male Genitalia 4 X 4 hour Sessions) Urology Core Clerkship 1999-2002 Senior Students – (Average 3-4 Senior Students Per Month) Prior to 2002 all senior student were required to rotate through the urology service and attend 4 one hour lectures every other week for a majority of the Page 3 Thomas A. Gardner, M. D. year. I would generally give one of the 4 lectures half of the time. L897 Urology Senior Elective (IU or Non-IU) (1- 4 senior students per month from July to October). These students would rotate on the urology service attend clinics and operative procedures. L804 Urology Research Elective (1-2 students per year, spending time in the research lab or clinical research project S700 Surgical Core Rotation – Director & Lecturer - Urology Surgical Subspecialty 2002 – Present All 3rd year students attend 3 hours of lectures, I give 2 of the 3. Nine series of lectures are given for the year. I also developed the lecture series and arranged the rotation schedule for the student when urology became part of this course. L700 and overlapped for one year with S700. Graduate Student Course Number Course Information J854 Spring 2004 Course Title: Hematopoiesis – Lecture Title: Vaccine Trials for Urologic Cancer Students: 8-12 Format: Lecture (1 hr) and Small Group Discussion (1.5 Hrs) J828 Fall 2004 Course Title: Virology Lecture Title: Adenovirus and Parvovirus Students: 8-12 Format: Lecture (1 hr) and Small Group Discussion (1.5 Hrs) J802 Course Title: Microbiology and Immunology Summer Research Rotation. (1 to 2 Graduate students pending 1 month in the lab.) 2002 Philip Abosh 2003 Juan Jimenez and Student Mentoring: Formal Phillip Abosh 2002 – Present Ph.D Committee – Member Juan Jimenez 2004 – Present Ph.D. Advisor and Mentor for F31-CA106215-01 Joseph Klink 2004 – Academic Advisor – Interested in Urology Informal I have mentored Medical Students, Residents and Fellows throughout my career at IU. T. Shirakawa, MD, PhD 1998-9 at UVA, now at Kobe University as Assistant Prof. M. Moghaddam, MD 2000-2002, now Assistant Professor in Iran A Mosharafa, M.D. 2003-2004 now Assistant Professor in Epypt SP Raikwar, Ph.D 2002-2005 now Assistant Scientist ,Univ. of Wisconsin JA Jiménez 2002-Present MD/PhD Student (PhD Advisor) M Mellon 2006-2008 P&T Dossier CV 03/2010 Page 4 Thomas A. Gardner, M. D. CME Courses Taught 2000 Mini Medical School - Gene Therapy and Prostate Cancer Location: University Place Sponsor Dean’s Office CME Course Title: “The 8Th Annual Family Practice Update Date: June 1, 2002 Location: University Place Conference Center Sponsor: Indiana University, School of Medicine, Division of CME Title “Prostate Disorders, Diagnosis and Treatment” CME Course Title: “Sexual Health Hospital Symposia” –Half-Day CME Program Date: September 27, 2003 Location: Indiana University Medical Center Sponsor: Boston University School of Medicine and National Foundation for Sexual Health Medicine Title: “Low Testosterone and Your Male Patients: Correlates, Symptoms and Treatments” CME Course Title: “Men’s Health Issues Update”- Half Day CME Program Date: March 19, 2004 Location: University Place Conference Center Sponsor: Indiana University, School of Medicine, Division of CME Title: “Benign Prostatic Hypertrophy: Update on Diagnoses and Medical Management” CME Course Title: “Latest Develop in Urology for Primary Care Physicians”, Date: April 24, 2004 Location: Marriot Kingsgate Conference Center Sponsor: Lecture Titles “Latest Advances in Diagnosing and Treating Erectile Dysfunction” And “Case Study: ED and Men’s Sexual Health: Importance of Asking” CME Lecture Title: “Erectile Dysfunction 2004 Update” Date: June 24, 2004 Location: Indian Palace, Indianapolis, IN University Place Conference Center Sponsor: VAMC, Division of CME CME Lecture Title: “Kidney Masses: Evaluation and Treatment” Date November 12, 2004 Location: Holiday Inn Conf Center Sponsor: Urology Nursing Society Inc. CME Lecture Titles: “2004 Treatment for Metastatic Prostate Cancer”, “HIFU and Cryotyherpy for Prostate Cancer” and “Gene Therapy for Prostate Cancer” Date: September 23, 2004 Location: University of Minnesota, Center for Prostate Cancer Symposium CME Lecture Titles: “2009 Prostate Cancer Update" Date: July 21, 2009 Location: Union Hospital, Evansville IN P&T Dossier CV 03/2010 Page 5 Thomas A. Gardner, M. D. Clinical Teaching Clinical instruction of medical students, residents and fellows is conducted during my clinical activities at University Hospital, Wishard and VA Medical Center. In 1999 2001 a majority of my clinical teaching occurred at Wishard Memorial Hospital at which time I almost independently supported the clinical activities of the Urology Service. From 2002 until present I spend 1.5 days seeing patients in the clinic and 2.5 days in the operating room. PROFESSIONAL SERVICE: (1) Service to the discipline (a) State and Regional, Public Service Announcements, Prostate Cancer TV (Channel 13, RTV6, Health Beat) Radio (Sound of Medicine) CME and non-CME Lectures thought the State and Region (b) National and international [list public offices, committees, organizations]; National Grant Reviews 2001 - DOD – CDMRP Prostate Cancer Research Program (PCRP) 2002 - DOD – CDMRP (PCRP) – Molecular Biology and Genetics 2002 - DOD – CDMRP (PCRP) – Consortium Award 2003 – NIH/NCI - R 03-124 NIAID 2005 - DOD – CDMRP (PCRP) – Clinical Trials Award 2006- DOD- CDMRP (PCRP)-Clinical & Experimental Therapeutics-1 International Grant Review 2002 - Canadian Institutes of Health Research – External reviewer 2003 – Fonds zur Frderung der wissenschaftlichen Forschung (FWF) Austrian Science Fund- External Reviewer International Consultant Korea University - Gene Therapy Research Program Kobe University - Gene Therapy Research Program (2) service to patients/clients and related clinical institutions; 1. “Phase I Study of Ad-OC-TK Plus Valacyclovir for the Treatment of Metastatic Recurrent Prostate Cancer” Sponsor Investigator, Status Closed, PI Gardner, Co-PI Chung. 2. “Clinical Investigation of High Intensity Focused Ultrasound (HIFU) For the Treatment of Benign Prostatic Hyperplasia (BPH)” Sponsor FocusSurgery, Status Open (6/8/93), PI Gardner, Co-PI: Birhle, Foster, Shalhav, Koch. 3. “Cox II Inhibitors in the Treatment of Bladder Cancer” Sponsor NIH, Open (12/9/01) PIFoster, Co-PI: Bihrle, Gardner, Koch. 4. “Phase III Randomized, Double- Blind Study of DFMO vs. Placebo In Low Grade superficial Bladder Cancer” Sponsor ILEX Onc., Status Open (3/17/99) PI- Foster Co-PI: Bihrle, Gardner, Koch, Mulcahy, Shalhav, Williams 5. “The Selenium and Vitamin E Chemoprevention Trial(SELECT)” Sponsor NCI, Status Open(7/2/01) PI Koch Co-PI: Foster, Gardner 6. Feasibility Study for Organ Confined Prostate Cancer Treatment with HIFU Using SONABLATE™ System Sponsor Focus Surgery, Status Open(7/25/01) PI – Koch; Co-PI: Gardner 7. Feasibility Study for Locally Recurrent Prostate Cancer Treatment Using SONABLATE™ System Sponsor FocusSurgery, Status Open(5/14/01) PI – Koch; Co-PI: Gardner P&T Dossier CV 03/2010 Page 6 Thomas A. Gardner, M. D. 8. A Multicenter, Phase IIb, Four Arm, Dose Finding, Randomized, Placebo Controlled Study to Determine The Long Term Prostate Cancer Chemoprevention Efficacy and Safety Of 20 mg, 40 mg, and 60 mg Daily of GTX-006 in Men with High Grade Prostate Intraepithelial Neoplasia (PIN) Sponsor GTx; Status Open(7/2/01); PI- Koch; Co-PI: Bihrle, Foster, Gardner, Mulcahy 9. A Randomized, Double Blind, Placebo Controlled Phase 3 Trial of Immunotherapy With Autologous Antigen Presenting Cells Loaded With PA2024 (Provenge, AOC8015) in Asymptomatic Subjects With Gleason Sum Less than or Equal to 7, Metastatic, Androgen Independent Prostatic Adenocarcinomas. Sponsor Dendreon Corp. [D9902] PI Gardner 10. An Open Label, Single Arm Trial of Immunotherapy with Autologous Antigen Presenting Cells Loaded with PA2024 (APC8015F) for Subjects with Objective Disease Progression and Disease-Related Pain on Trial D9902 Part B PI: Thomas A. Gardner 11. A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5 mg Administered Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer. PI Thomas A. Gardner 12. A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of IC351(LY450190) Administered "On Demand" to Patients with Erectile Dysfunction Following Bilateral Nerve-Sparing Radical Retropubic Prostatectomy, PROTOCOL H6D-MC-LVCI Sponsor Lilly, Status Pending, PI Mulcahy, Co-PI: Gardner, Koch Investigational New Drug/RAC Applications 1. BB-IND 8115 - Adenovirus Vector (Ad-OC-TK, BioReliance) Expressing Thymidine Kinase Gene Under Regulation of an Osteocalcin Promoter and Valacyclovir (PI Gardner TA) 2. RAC #-276 - Phase I Study of Ad-OC-TK Plus Valacyclovir for the Treatment of Metastatic Recurrent Prostate Cancer (PI Gardner TA) 3. RAC #-426 - Phase I Study of Ad-OC-E1a for the Treatment of Metastatic Recurrent Prostate Cancer (PI Gardner TA) Patent(s) 1. 6,342,384 (1/29/02) Production of adenoviral vectors using serum-free suspension cell culture in a hollow fiber system. Patents Pending 1. MN - promoter based gene therapy for the treatment of malignancies. 2. ß-HCH promoter based gene therapy for testicular malignancies. (3) Community service (Prostate Cancer Support Group Presentations) (1) US TOO Charlottesville Chapter, Charlottesville, VA 4/97 (2) US TOO of the Valley, Waynesboro, VA 2/98 (3) Man-to-Man (ACS-Sponsored) Lynchburg Chapter, Lynchburg, VA 10/97 (4) US TOO Richmond Chapter, Richmond, VA 3/98 (5) US TOO Charlottesville Chapter, Charlottesville, VA 4/98 (6) Man-to-Man (ACS-Sponsored), Roanoke, VA 4/98 (7) US TOO Annual Regional Directors Meeting, Chicago, IL 10/98 (8) US TOO of the Valley, Waynesboro, VA 2/99 (9) US TOO Charlottesville Chapter, Charlottesville, VA 4/99 (10) Man-to-Man (ACS-Sponsored) Lynchburg Chapter, Lynchburg, VA 4/99 (11) US TOO Richmond Chapter, Richmond, VA 6/99 (12) Man-to-Man (ACS-Sponsored) – St. Vincent Hospital, Indianapolis, IN, 9/99 (13) Man-to-Man (ACS-Sponsored) – St. Vincent Hospital, Indianapolis, IN 1/00 (14) Man-to-Man (ACS-Sponsored) – St. Vincent Hospital, Indianapolis, IN 1/01 (15) Man-to-Man (ACS-Sponsored) – St. Vincent Hospital, Indianapolis, IN 1/02 P&T Dossier CV 03/2010 Page 7 Thomas A. Gardner, M. D. (16) (17) (18) (19) (20) Man-to-Man (ACS-Sponsored) – St. Vincent Hospital, Indianapolis, IN 1/03 Man-to-Man (ACS-Sponsored) – St. Vincent Hospital, Indianapolis, IN 1/04 Man-to-Man (ACS-Sponsored) – St. Vincent Hospital, Indianapolis, IN 1/05 Man-to-Man (ACS-Sponsored) – St. Vincent Hospital, Indianapolis, IN 1/06 Man-to-Man (ACS-Sponsored) – St. Vincent Hospital, Indianapolis, IN 1/07 P&T Dossier CV 03/2010 Page 8 Thomas A. Gardner, M. D. UNIVERSITY SERVICE: (1) university administrative service Executive Council of Wishard Memorial Hospital - Member Operating Room Committee Wishard Memorial Hospital - Member IUMG-SC Wishard Specialty Group - Member Urology Clinic Redesign Team of Wishard Memorial Hospital - Member (2) university committee service (a) departmental, Walther Oncology Center, Member Walther Oncology Center, Internal Advisory Board Member (b) school, NIH Cancer Center Scientific Review Committee (SRC) - Member NIH GCRC Advisory Committee - Member Institutional Review Board - Alternate Member Indiana University Cancer Center – Member Experimental Therapeutics IUCC Bone Cancer Working Group - Member Clinical Research Strategic Planning Committee - Member Radiation Oncology Chair Search Committee- Member Cancer Center Director Search Commitee -Member (c) campus, Research III Strategic Planning Committee (d) system [list name of committee, nature of participation, duration]; (3) student service [list student group, position/role, duration, formal-informal counseling Not applicable OTHER PROFESSIONAL ACTIVITIES: Editorial Boards/ Journal Reviews 1997 – Reviewer - Journal of Urology 1997 – Reviewer – Investigative Urology 1998 – Editor - Gene Therapy and Molecular Biology 1999 – Editor - Tumor Targeting 2001 – Reviewer – Journal of Experimental Therapeutics 2001 – Reviewer – Molecular Therapy 2002 – Reviewer – Cancer Research 2002 – Reviewer - Urology 2002 – Reviewer – Cancer Research Invited Presentations/Lectureships/Grand Rounds 1. Gardner TA, Li PS, Lopez M, Wright EJ, Goldstein M. Microsurgical vasoepididymostomy: Which technique is best? The Department of Urology Grand Rounds, General Hospital, Salzburg, Austria, February 1995. 2. Gardner TA, Kaneda Y, Liu D, Ko SC, Ginsberg RJ, Burt M, Kao C, Chung LWK. Gene therapy for the treatment of sarcoma. Thoracic Service Grand Rounds-Department of SurgeryMemorial Sloan-Kettering Cancer Center, New York, NY, March 1998. 3. Gardner TA, Ko SC, Kao C, Shirakawa T, Cheon J, Gotoh A, Wu TT, Sikes RA, Zhau HE, Cui Q, Balian G, Chung LWK. Exploiting stromal-epithial interaction for model development and new strategies of gene therapy for prostate cancer and osteosarcoma metastases. International Conference on Gene Therapy, Crete, Greece, August 1998. 4. Gardner TA, Ko SC, Kao C, Cheon J, Shirakawa T, Chung LWK. Tumor-restricted adenoviral gene therapy applied to osteosarcoma and prostate cancer. Cold Spring Harbor Laboratory’s Meeting on Vector targeting strategies for therapeutic gene delivery, March 1999. P&T Dossier CV 03/2010 Page 9 Thomas A. Gardner, M. D. 5. Gardner TA, Ko SC, Kao C, Chung LWK. Ad-OC-TK gene therapy for the treatment of metastatic osteosarcoma. Pediatric Oncology Service Grand Rounds-Department of MedicineMemorial Sloan-Kettering Cancer Center, New York, NY, June 1999. 6. Gardner TA. Gene therapy for the treatment of urologic malignancies. Clinical Science Symposia at the 32nd Annual Meeting of American Society of Nephrology, Miami, FL, November 1999. 7. Gardner TA. “High Intensity Focused Ultrasound for Localized and Recurrent Prostate Cancer” Grand Rounds, Department of Urology, University of Michigan, August, 2000. 8. Gardner TA. “Results of a Phase I Trial of Ad-OC-TK/VAL for Metastatic and Recurrent Prostate Cancer.” Prostate Cancer SPORE Lectureship, Department of Urology, University of Michigan, August, 2000. 9. Gardner TA. Genetics underlying urologic malignancies. Fourth Uro-Oncology Conference, Lake Louise, Alberta, Canada, February 24-28, 2001. 10. Gardner TA. “Basic gene therapy for the uro-oncologists”. Fourth Uro-Oncology Conference, Lake Louise, Alberta, Canada, February 24-28, 2001. 11. Gardner TA. “Gene therapy approaches for metastatic prostate and kidney cancer.” Grand Rounds, Dept. of Urology, New York Hospital-Cornell Medical Center, NY, March 21, 2001. 12. Gardner TA, “Gene Therapy for Osteosarcoma” CTEP sponsored “Biology of Childhood Osteogenic Sarcoma and Potential Targets for Therapeutic Development. Bethesda MD, November 29-30, 2001. 13. Gardner TA, “Gene Therapy, What is it?” State of the Art lecture at NCS of AUA 2001 Chicago IL, January 17, 2002. 14. Gardner TA, “Chasing the Cash to Find the Cure” American Marketing Association, South Bend IN, January 24, 2002. 15. Gardner TA, “Treatment Options for Advanced and Recurrent Prostate Cancer:Vaccines and Thermal Therapy” Community Cancer Care Quarterly Seminars, April 29th, 2004. 16. Gardner TA, Visiting Professor – Prostate Cancer Symposium University of Minnesota, September 23,2004 17. Gardner TA, “Gene Therapy, What is it?” State of the Art lecture at NCS of AUA 2004 , October 15, 2004. Personal CME and non CME Clinical and Research Activity 2000 – 2004 325 hours Departmental and IU CME Credits 1999 – 2004 175 hours CME Credits from Meeting New clinical techniques acquired and incorporated in to clinical practice *Each of these techniques required formal training (online up to two day hands on courses) and proctoring leading authority in the procedure. 1. 2. 3. 4. 5. 6. 7. 8. 9. High Intensity Focused Ultrasound for Prostate Advanced Laparoscopy DaVinci Robotic Laparoscopy Kidney Cryotherapy Prostate Cryotherapy Transurethral Microwave Thermal Therapy Transurethral Needle Ablation of Prostate Interstim Sacral Nerve Implantation TVT, TOT, TVT-O Urethral Sling Procedures P&T Dossier CV 03/2010 Page 10 Thomas A. Gardner, M. D. GRANTS AND FELLOWSHIPS: 1999-2007 Intramural Direct Total $155,000 1999-2007 Extramural Direct Total $1,225,000 1996-1998 1996-1998 1996-1997 1998 2000 2001 2000-2003 2000-2005 2002-2003 2002-2003 2003-2006 2005-2006 American Foundation of Urologic Disease Research Scholar Fellowship NIH-Funded Training Program Cell and Molecular Biology of the Urogenital System 5-T32-DK07642 (PI-Gardner TA, 32,300/yr) ACS-Institutional Research Grant-Co-Investigator (PI-Kao, C) DOD DAMD17-98-1-8643 Co-Investigator (10%) (PI-Kao, C) IUCC Bone Cancer Pilot Grant (PI Gardner TA, Direct $ 50,000) IUCC Prostate Caner Pilot Grant (PI Gardner TA, Direct $ 40,000) DOD DAMD17-00-1-0027 New Investigator Award (PI Gardner TA, Direct $225,000) KO8 CA79544-01A2 Clinical Scientist Training Grant (PI Gardner TA, Direct $625,000) Kidney Research and Tissue Storage (Larson Gift) (PI Gardner TA, Direct $ 50,000) IUCC Renal Cell Carcinoma Pilot Project (PI Gardner TA, Direct $ 15,000) DOD DAMD17-03-1-0077 New Idea Award (PI Gardner TA, Direct $375,000) DOD Clinical Trial Development Award (PI Gardner TA, Direct $100,000) Funding Active Funding (1) Grant # DAMD17-00-1-0027 Funding Period11/15/99-11/14/02 Role PI Title “Tumor restricted gene therapy for metastatic prostate cancer” The objective of this grant is to test the hypothesis that a tissue specific oncolytic vector can eradicate human prostate cancer growing in an established metastatic animal model. There is no overlap of the specific aims between this grant and the proposed grant. The grants share several techniques including the animal model and adenoviral production. (2) Grant # NIH/NCI - 1R01 CA80825-01A2 12/1/00-5/31/03 Role Co-Investigator Title “Tissue-specific gene therapy of pulmonary metastasis” The objective of this proposal is to study the ability of locoregional delivery and tissuespecific promoter to target osteosarcoma in a metastatic rat model. (3) Grant # 2987536 Funding Period 5/1/02 – 4/30/03 Renal Cell Carcinoma Pilot Project (Direct $ 15,000) Role PI Title: “ MN promoter Activity in Renal Cell Carcinoma” The objective of this pilot project was to generate preliminary data to allow for a R01 submission in tumor specific oncolysis of renal cell carcinoma. (4) Grant # NIH/NCI 1R01 CA80825-01A2 Funding Period 12/1/00-5/31/02 Role Co-investigator PI C Kao Direct Costs 849,850 Title: “Tissue-specific gene therapy of pulmonary metastasis” The objective of this proposal is to study the ability of locoregional delivery and tissuespecific promoter to target osteosarcoma in a metastatic rat model. (5) Grant # NIH 2 R44 CA83244-02: Funding Period11/2000-02/2004 Role : Consultant Direct $3000/year, 2 years Title "Quantitative Imaging & Treatment with Focused Ultrasound," (Phase II SBIR) The objective of this proposal is to quantify the temperatures associated high intensity focused ultrasound. (6) Grant # NIH 2 R44 CA81340-02A2: Role: Consultant P&T Dossier CV 03/2010 Page 11 Funding Period 5/2002-4/2004 Direct $5000 Thomas A. Gardner, M. D. Title "High Intensity Ultrasound for Prostate Treatment" (Phase II SBIR) The object of this proposal was to test a phased array transducer with Doppler capabilities. (7) Indiana ICMIC Planning Grant Funding Period 6/7/02 – 4/30/03 Role: PI Direct $36,116.77 (Acct #4688405) Title: “Micro-PET imaging of TK based gene therapy in Prostate cancer models” The object of this proposal was to non-invasively quantify the tumor burden in animal models of prostate cancer before and after application of gene therapy. (8) George M. O’Brien Center for Advanced Renal Microscopic Analysis, (PI Dr. Bruce A. Molitoris) Funding Period 2002 -2004 Role Co-Investigator (PI Raikwar S) Direct $42,000 (Acct #’s 4688630, 4688699) Title: Pilot Project 3 “Delineation of tumor vascular in response to anti-angiogenic gene therapy” The object of this proposal was to quantify the alteration in tumor vasculature in animal models of prostate cancer before and after application of gene therapy. (9) Grant # NIH KO8 CA79544-01A2 Funding Period: 7/01/00-6/30/05 Role PI Title “Locoregional gene therapy for cancer metastases” The objective of this grant is to test the hypothesis that a tissue specific and targeted toxic gene therapy can be safely and effectively delivered via locoregional perfusion to animals with human metastatic renal cell carcinoma and prostate cancer. There is no overlap of the specific aims between this grant and other support. The other support listed share several techniques including the animal model and adenoviral production. (10) Grant # DAMD17-03-1-0077 Funding Period: 5/1/03 – 4/30/06 Role: PI Title “Development and Pre-clinical evaluation of a novel ProstateRestricted Replication Competent Adenovirus-Ad-IU-1” The major goal of this proposal is to combine TK gene therapy and MicroPet imaging with replication competent adenovirus to target prostate cancer. (11) Grant # NIH 2 R44 DK059664-02A1: Funding Period: 6/2003-5/2005 Role: Consultant $5000/year Title: "Ultrasound Imaging and Therapy for Prostate Cancer," (Phase II SBIR) The major goal of this investigation is to further advance a HIFU device for prostate treatment using canine models. (12) Glaxo Smith Kline, AR140006 10/29/03 – 07/23/09 Role Institutioal PI Funding Support $247,380 Direct $61,470 Indirect Title :“A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5mg Administered Orally Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer”. (13) Dendreon Corporation, 10/02/03 – Current Title :“A Randomized, Double Blind, Placebo Controlled, Phase 3 Trial of Immunotherapy with Autologous Antigen Presenting Cells Loaded with PA2024… and An Open Label Single Arm Trial of Immunotherapy with Autologous Antigen Presenting Cells… PB01”. Funding Support $36,918 Direct $8,855 Indirect P&T Dossier CV 03/2010 Page 12 Thomas A. Gardner, M. D. PUBLICATIONS (Refereed): **All Publications should be considered an integration of research scholarship and professional service. (*Corresponding Authorship, #Equal First Authorship) 1. Gardner TA, Poppas DP, Wei JT, Blavias JG: Volvulus of the ileal conduit: A late complication. J. Urol. 152:948-950, 1994. 2. Ngadiman S, Hoda SA, Campbell WG Jr, Gardner TA, May M: Concurrent malakoplakia and primary squamous cell carcinoma arising in long standing chronic cystitis. Brit. J. Urol. 74:801-802, 1994. 3. Matthews GJ, Gardner TA, Eid JF: In vitro fertilization with intracytoplasmic sperm injection(ICSI) improves pregnancy rates for electroejaculated sperm. J. Urol. 155:1934-1937, 1996. 4. Gardner TA, Boyd S, Theodorescu D. Factors predicting hospital length of stay in patients treated by radical prostatectomy. Surg. Forum 48: 597-600, 1997. 5. Cheon J, Ko S-C, Gardner TA, Shirakawa T, Kao C, Chung LWK. Osteosarcoma: Osteocalcin promoter based suicide gene therapy in combination with methotrexate in a murine osteosarcoma model. Cancer Gene Therapy 4(5): 359-365, 1997. 6. Gotoh A, Ko SC, Shirakawa T, Cheon J, Kao C, Miyamoto T, Gardner TA, Ho LJ, Cleutjens C, Trapman J, Graham FL, Chung LWK. Development of prostate-specific antigen promoter-based gene therapy for androgen-independent human prostate cancer. J Urol 160: 220-229, 1998. 7. Gardner TA, Lemer ML, Schlegel PN, Waldbaum RS, Vaughan ED Jr., Steckel J. Microfocal prostate cancer: Biopsy cancer volume does not predict actual tumor volume. Brit J Urol 81(6):839-43, 1998. 8. Gardner TA, Ostad M, Mininberg DT. Diagnostic flexible peritoneoscopy: Assessment of the contralateral internal ring during unilateral herniorrhaphy. J Pediatr Surg 33(10): 1486-9, 1998. 9. Shirakawa T, Ko SC, Gardner TA#, Cheon J, Miyamoto T, Gotoh A, Chung LWK, Kao C. In vivo suppression of osteosarcoma pulmonary metastasis with intravenous osteocalcin promoter-based toxic gene therapy. Cancer Gene Therapy 5(5): 274-280, 1998. 10. Pavlovich CP, Gmyrek GA, Gardner TA, Poppas DP, Mininberg DT. Flexible transinguinal laparoscopy to assess the contralateral ring in pediatric inguinal hernias. Tech Urol 4(3): 141-4, 1998. 11. Shirakawa T, Gardner TA*, Ko SC, Bander N, Woo S, Gotoh A, Kamidono S, Chung LWK, Kao C. Cytotoxicity of Adenoviral-Mediated Cytosine Deaminase Plus 5-Fluorocytosine Gene Therapy is Superior to Thymidine Kinase Plus Acyclovir in a Human Renal Cell Carcinoma Model. J Urol 162:94954, 1999. 12. Shirakawa, T.; Gotoh, A.; Wada, Y.; Kamidono, S.; Ko, S. C.; Kao, C.; Gardner, T. A.; Chung, L. W.Tissue-specific promoters in gene therapy for the treatment of prostate cancer Mol Urol 4(2) 73-82, 2000 (summer) 13. R. Seip, M. Biswas, M. Kuznetsov, T. Gardner, and N. Sanghvi, "Transurethral High Intensity Focused Ultrasound: Catheter Prototypes and Experimental Results," IEEE Ultrasonics Symposium Proceedings, Vol. 2, 2000, pp. 1413-1416. 14. Shirakawa T, Gotoh, A, Gardner TA, Kao C, Zhang Z-J, Matsubara S, Wada Y, Hinata N, Fujisawa M, Hanioka K, Matsuo M, Kamidono S. P53 Adenoviral vector (Ad-Cmv-P53) induced prostatic growth inhibition of primary cultures of human prostate and an experimental rat model. J Gene Medicine 2:426-432, 2000. 15. Gardner TA, Bissonette EA, Petroni GR, McClain R, Sokoloff MH, and Theodorescu D. Surgical and postoperative factors affecting length of hospital stay after radical prostatectomy. Cancer 89:424-30, 2000. 16. Koeneman KS, Kao C, Ko SC, Yang L, Wada Y, Kallmes DF, Gillenwater JY, Zhau HE, Chung LWK, Gardner TA. Osteocalcin-directed gene therapy for prostate-cancer bone metastasis. World J Urol 18(2):102-10, 2000. 17. Gardner TA, Ko S-C, Yang L, Cadwell JJS, Chung LWK, Kao C. Serum-free recombinant production of adenoviral using a hollow fiber capillary system. Biotechniques 30:422-427, 2001. 18. Soergel TM, Koch MO, Foster RS, Bihrle R, Wahle G, Gardner TA, Jung SH. Accuracy of predicting long-term prostate specific antigen outcome based on early prostate specific antigen recurrence results after radical prostatectomy, J Urol, 166(6), 2198, 2001. P&T Dossier CV 03/2010 Page 13 Thomas A. Gardner, M. D. 19. Shirakawa T, Sasaki R, Gardner TA, Kao C, Zhang ZJ, Sugimura K, Matsuo M, Kamidono S, Gotoh A. Drug-resistant human bladder-cancer cells are more sensitive to adenovirus-mediated wild-type p53 gene therapy compared to drug-sensitive cells, Int J Cancer, 94(2), 282-289, 2001. 20. Matsubara S, Wada Y, Gardner TA, Egawa M, Park MS, Hsieh CL, Zhau HE, Kao C, Kamidono S, Gillenwater JY, Chung LWK. A conditional replication-competent adenoviral vector, Ad-OC-E1a, to cotarget prostate cancer and bone stroma in an experimental model of androgen-independent prostate cancer bone metastasis, Cancer Res, 61(16): 6012 - 6019, 2001. 21. Cheon J, Moon DG, Cho HY, Park HS, Kim JJ, Gardner TA, Kao C. Adenovirus –mediated suicide gene therapy in an orthotopic murine bladder tumor model. Int J Urol 9(5):29-36, 2002. 22. Siqueira, T. M., Jr., Kuo, R. L., Gardner, T. A., Paterson, R. F.Stevens, L. H., Lingeman, J. E., Koch, M. O., Shalhav, A. L. Major complications in 213 laparoscopic nephrectomy cases: the Indianapolis experience. J Urol 168(4 OCT):1361-5, 2002 23. Siqueira, T. M., Jr., Gardner, T. A., Kuo, R. L., Paterson, R. F., Stevens, L. H., Lingeman, J. E., Shalhav, A. L.. One versus two proficient laparoscopic surgeons for laparoscopic live donor nephrectomy. Urology 60(3 SEP) 406-9, discussion 409-10, 2002 24. R. Seip, J. Tavakkoli, R. Carlson, A. Wunderlich, N. Sanghvi, K. Dines, and T. Gardner, "High-Intensity Focused Ultrasound (HIFU) Multiple Lesion Imaging: Comparison of Detection Algorithms for RealTime Treatment Control," IEEE Ultrasonics Symposium Proceedings, 2002, pp. 1395-1398. 25. Shalhav, A. L., Siqueira, T. M., Jr., Gardner, T. A., Paterson, R. F., Stevens, L. H. Manual specimen retrieval without a pneumoperitoneum preserving device for laparoscopic live donor nephrectomy., J Urol 168(3 SEP):941-4, 2002. 26. Shalhav, A. L., Barret, E., Lifshitz, D. A., Stevens, L. H., Gardner, T. A., Lingeman, J. E. Transperitoneal laparoscopic renal surgery using blunt 12-mm trocar without fascial closure. J Endourol 16(1 FEB): 43-6, 2002 27. Uchida T, Sanghvi NT, Gardner TA, Koch MO, Ishii D, Minei S, Satoh T, Hyodo T, Irie A, Baba S. Transrectal high intensity focused ultrasound for theatment of patients with stage T1b-2N0M0 localized prostate cancer: A preliminary report. Urology 59(3):394-399, 2002. 28. Zhang S, Gu J, Yang N-S, Kao C, Gardner TA, Eble JN, Cheng L. Relative promoter strengths in four human prostate cancer cell lines evaluated by particle bombardment-mediated gene transfer. Prostate 51:286-292, 2002. 29. Zhang S, Zeng G, Kao C, Gardner TA, Sweeney C, Yang N-S, Eble JN, Cheng L. Fas-Fas ligand signaling pathway mediates an interleukin-12-induced rejection of murine prostate tumor system. Prostate 52:1-8, 2002. 30. Jiang J, Ulbright TM, Zhang S, Eckert GJ, Kao C, Gardner TA, Koch MO, Eble JN, Cheng L. Fas and Fas ligand expression is elevated in prostatic intraepithelial neoplasia and prostatic adenocarcinoma. Cancer 95(2):296-300, 2002. 31. Gardner TA#, Sloan J, Raikwar SP, Kao C, Prostate cancer Gene Therapy Past experiences and Future Promise, Cancer and Metastasis Reviews 21:137-145, 2002. 32. Hong H, Koch MO, Foster RS, Bihrle R, Gardner TA, Fyffe J, Ulbright TM, Eble JN, Cheng L. Anatomical distribution of periprostatic adipose tissue: A mapping study of 100 radical prostatectomy specimens. Cancer (In Press), 2003. 33. Kubo, H, TA Gardner#, Y Wada, KS Koeneman, A Gotoh, L Yang, C Kao, SD Lim, MB Amin, H Yang, ME Black, S Matsubara, M Naqkagawa, JY Gillenwater, HE Zhau, LW Chung. Phase I dose escalation clinical trial of adenovirus vector carrying osteocalcin promoter-driven herpes simplex virus thymidine kinase in localized and metastatic hormonerefractory prostate cancer. Hum, Gene Therapy 14:227-241, 2003. 34. Lee, S-J, K Lee, X Yang, C Jung, TA Gardner, H-S Kim, M-H Jeng, C Kao. NFATc1 with AP-3 site binding specificity mediates gene expression of prostate-specific-membraneantrigen. J Mol. Biol. 330:749-760, 2003. 35. Zeng, G, Z Hu, MS Kinch, DA Flockhart, C Kao, TA Gardner, S Zhang, L Li, LA, Koch MO Baldridge, TM Ulbright, JN Eble, L Cheng. High Level Expression of EphA2 Receptor Tyrosine Kinase in Prostatic Intraepithelial Neoplasia. Am. J Pathol. 163:2271-2276, 2003. P&T Dossier CV 03/2010 Page 14 Thomas A. Gardner, M. D. 36. Gorlick, R., Anderson, P., Andrulis, I.,Arndt, C.,Beardsley, G. P.,Bernstein, M.,Bridge, J., Cheung, N. K., Dome, J. S., Ebb, D. Gardner, T.A, Gebhardt, M., Grier, H., Hansen, M., Healey, J.Helman, L., Hock, J., Houghton, J., Houghton, P., Huvos, A., Khanna, C., Kieran, M.Kleinerman, E., Ladanyi, M., Lau, C., Malkin, D., Marina, N., Meltzer, P., Meyers, P., Schofield, D., Schwartz, C., Smith, M. A., Toretsky, J., Tsokos, M., Wexler, L., Wigginton, J.Withrow, S., Schoenfeldt, M., Anderson, B. Biology of childhood osteogenic sarcoma and potential targets for therapeutic development: meeting summary. Clin Cancer Res 9(15 NOV):5442-53 37. Hong, H., Koch, M. O., Foster, R. S., Bihrle, R., Gardner, T. A., Fyffe, J., Ulbright, T. M., Eble, J. N., and Cheng, L. Anatomic distribution of periprostatic adipose tissue: a mapping study of 100 radical prostatectomy specimens. Cancer, 97: 1639-1643, 2003. 38. Brandli, D. W., Koch, M. O., Foster, R. S., Bihrle, R., and Gardner, T. A. Biochemical disease-free survival in patients with a high prostate-specific antigen level (20-100 ng/mL) and clinically localized prostate cancer after radical prostatectomy. BJU Int, 92: 19-22; discussion 22-13, 2003. 39. Koch, M. O., Nayee, A. H., Sloan, J., Gardner, T., Wahle, G. R., Bihrle, R., and Foster, R. S. Early catheter removal after radical retropubic prostatectomy: long-term followup. J Urol, 169: 2170-2172, 2003. 40. Paterson, R. F., Barret, E., Siqueira, T. M., Jr., Gardner, T. A., Tavakkoli, J., Rao, V. V., Sanghvi, N. T., Cheng, L., and Shalhav, A. L. Laparoscopic partial kidney ablation with high intensity focused ultrasound. J Urol, 169: 347-351, 2003. 41. Mosharafa, A., Koch, M., Shalhav, A., Gardner, T., Logan, T., Bihrle, R., and Foster, R. Nephrectomy for metastatic renal cell carcinoma: Indiana University experience. Urology, 62: 636-640, 2003. 42. Chung, L. W., Hsieh, C. L., Law, A., Sung, S. Y., Gardner, T. A., Egawa, M., Matsubara, S., and Zhau, H. E. New targets for therapy in prostate cancer: modulation of stromal-epithelial interactions. Urology, 62: 44-54, 2003. 43. Hsieh, C. L., Gardner, T. A., Miao, L., Balian, G., and Chung, L. W. Cotargeting tumor and stroma in a novel chimeric tumor model involving the growth of both human prostate cancer and bone stromal cells. Cancer Gene Ther, 11(2 FEB): 148-155, 2004. 44. Cheng, L, GT MacLennan, C Pan, TD Jones, S Zhang, CR Moore, J Gu, C Kao, TA Gardner. Allelic loss of the active X chromosome during bladder carcinogenesis. Arch Pathol Lab Med. 128(2 FEB):187-190, 2004. 45. Zheng, Q-H, J-Q Wang, X Liu, X Fei, BH Mock, BE Glick-Wilson, ML Sullivan, SP Raikwar, TA Gardner, C Kao, GD Hutchins. An improved total synthesis of PET HSV-tk gene reporter probe 9-(4-[18F]fluoro-3-hydroxymethylbutyl)guanine ([18F]FHBG). Syn. Commun. 34:671685, 2004. 46. Shirakawa, T., Gotoh, A., Zhang, Z., Kao, C. , Chung, L. W., Gardner, T. A.. Development of human chorionic gonadotropin subunit-beta promoter-based toxic gene therapy for testicular cancer. Urol 63(3 MAR):613-18, 2004 47. Q-H. Zheng, T.A. Gardner, S.P. Raikwar, C. Kao, K.L. Stone, T.D. Martinez, B.H. Mock, X. Fei, J-Q. Wang, G.D. Hutchins: [11C]Choline as a PET biomarker for assessment of prostate cancer tumor models. Bioorg. Med. Chem. 2004, 12(11), 2887-2893. 48. Hong H, Kao C, Jeng M, Eble JN, Koch MO, Gardner TA, Zhang S, Li L, Pan C, Hu Z, MacLennan GT, Cheng L:Aberrant expression of CARM1, a transcriptional coactivator of androgen receptor, in the development prostate cancer and androgen-independent status. Cancer 101:83-89, 2004. 49. Sweeney C, Li L, Shanmugam R, Bhat-Nakshatri P, Jayaprakasan V, Baldridge LA, Gardner TA, Smith M, Nakshatri H, Cheng L. Nuclear Factor Kappa B is Constitutively Activated in Prostate Cancer In Vitro and is Over-expressed in Prostatic Intra-epithelial Neoplasia and Adenocarcinoma of the Prostate. Clinical Cancer Research 10(16):5501-7 2004(AUG) P&T Dossier CV 03/2010 Page 15 Thomas A. Gardner, M. D. 50. Sundaram CP, Koch MO, Gardner TA, Bernie JE (2005). "Utility of the fourth arm to facilitate robot-assisted laparoscopic radical prostatectomy." BJU Int 95(1): 183-6.(JAN) 51. Wang, JQ, Fei X, Gardner TA, Hutchins GD, Zheng QH (2005). "Synthesis of 2-amino-6-(4[11C]methoxyphenylthio)-9-[2-(phosphonomethoxy)ethyl]purine bis(2,2,2-trifluoroethyl) ester as a novel potential PET gene reporter probe for HBV and HSV-tk in cancers." Bioorg Med Chem 13(2): 549-56. (JAN) 52. Ou YC, Gardner TA, Kao C, Zhau HE, Chung LWK. (2005). "A potential for tissue restrictive gene therapy in renal cell carcinoma using MN/CA IX promoter." Anticancer Res 25(2A): 881-6.(MAR) 53. Li X, Zhang YP, Kim HS, Bae KH, Stantz, KM, Lee, SJ, Jung C, Jimenez JA, Gardner TA, Jeng MH, Kao C. (2005). "Gene therapy for prostate cancer by controlling adenovirus E1a and E4 gene expression with PSES enhancer." Cancer Res 65(5): 1941-51. (MAR) 54. Cheng L, Koch MO, Juliar BE, Daggy JK, Foster RS, Bihrle R, Gardner TA. (2005). "The combined percentage of Gleason patterns 4 and 5 is the best predictor of cancer progression after radical prostatectomy." J Clin Oncol 23(13): 2911-7. (MAY) 55. Jung C, Kim RS, Zhang H, Lee SJ, Sheng H, Loehrer PJ, Gardner TA, Jeng MH, Kao C. (2005). "HOXB13 is downregulated in colorectal cancer to confer TCF4-mediated transactivation." Br J Cancer 92(12): 2233-9. (JUN) 56. Koch MO, Gardner TA (2005). "Thermal-based treatment options for localized prostate cancer." Curr Treat Options Oncol 6(5): 379-87. (JUN) 57. Armatys S, Koch MO, Bihrle R, Gardner TA, Cheng L: Is it necessary to separate clinical stage T1c from T2 prostate adenocarcinoma? BJU Int 96: 777-780, 2005.(OCT) 58. Malaeb BS, Gardner TA, Margulis V, Yang L, Gillenwater JY, Chung LWK, Macik G, Koeneman KS. (2005). "Elevated activated partial thromboplastin time during administration of first-generation adenoviral vectors for gene therapy for prostate cancer: identification of lupus anticoagulants." Urology 66(4): 830-4.(OCT) 59. Armatys SA, Cheng L, Gardner TA, Sundaram CP (2005). "Pulmonary sequestration presenting as retroperitoneal cyst: case report." J Endourol 19(8): 997-9. (OCT) 60. Bernie JE, Venkatesh R, Bargman V, Gardner TA, Cheng L, Sundaram CP. (2005). "Comparison of laparoscopic pyeloplasty with and without robotic assistance." Jsls 9(3): 258-61.(NOV) 61. Bernie JE, Ng J, Bargman V, Gardner TA, Cheng L, Sundaram C P(2005)."Evaluation of hydrogel tissue sealant in porcine laparoscopic partial-nephrectomy model." J Endourol 19(9): 1122-6. (NOV) 62. Li X, Zhang J, Gao H, Vieth E, Bae KH, Zhang YP, Lee SJ, Raikwar S, Gardner TA, Hutchins GD, VanderPutten D,Kao C, Jeng MH (2005). "Transcriptional targeting modalities in breast cancer gene therapy using adenovirus vectors controlled by alpha-lactalbumin promoter." Mol Cancer Ther 4(12): 1850-9.(DEC) 63. Raikwar SP, Temm CJ, Raikwar NS, Kao C, Molitoris BA, Gardner TA. (2005). "Adenoviral vectors expressing human endostatin-angiostatin and soluble Tie2: enhanced suppression of tumor growth and antiangiogenic effects in a prostate tumor model." Mol Ther 12(6): 1091-100. (DEC) 64. Gardner TA, Koch MO. (2005). "Prostate cancer therapy with high-intensity focused ultrasound." Clin Genitourin Cancer 4(3): 187-92. (DEC) 65. Li X, Raikwar SP, Liu YH, Lee SJ, Zhang YP, Zhang S, Cheng L, Lee SD, Juliar BE, Gardner TA, Jeng MH, Kao C. (2006). "Combination therapy of androgen-independent prostate cancer using a prostate restricted replicative adenovirus and a replication-defective adenovirus encoding human endostatin-angiostatin fusion gene." Mol Cancer Ther 5(3): 676-84. (MAR) 66. Jimenez JA, Kao C, Raikwar S, Gardner TA. (2006). "Current status of anti-angiogenesis therapy for prostate cancer." Urol Oncol 24(3): 260-8.(MAY) P&T Dossier CV 03/2010 Page 16 Thomas A. Gardner, M. D. 67. Desai P, Jimenez JA, Kao C, Gardner TA. (2006). "Future innovations in treating advanced prostate cancer." Urol Clin North Am 33(2): 247-72, viii.(MAY) 68. Li X, Jung C, Liu YH, Bae KH, Zhang YP, Zhang HJ, Vanderputten D, Jeng MH, Gardner TA, Kao C. (2006). "Anti-tumor efficacy of a transcriptional replication-competent adenovirus, Ad-OC-E1a, for osteosarcoma pulmonary metastasis." J Gene Med 8(6): 67989. (JUN) 69. Li X, Liu YH, Zhang YP, Zhang S, Pu X, Gardner TA, Jeng MH, Kao C (2007). Fas ligand delivery by a prostate-restricted replicative adenovirus enhances safety and antitumor efficacy. Clin Cancer Res 13(18): 5463-73. 70. Mellon MJ, Ahn M, Jimenez JA, Kao C, Gardner TA. (2008) Anti-angiogenic gene therapy for metastatic renal cell carcinoma produces tumor growth suppression in an athymic nude mouse model. J Urol 179(2): 737-42. J Urol. 2008 Feb;179(2):737-42. Epub 2007 Dec 20. 71. Li X, Liu YH, Lee SJ, Gardner TA, Jeng MH, Kao C (2008). Prostate restricted replicative adenovirus expressing human endostatin-angiostatin fusion gene exhibiting dramatic antitumor efficacy. Clin Cancer Res 14(1): 291-9. 72. Mellon MJ, Bae KH, Jimenez JA, Kao C, Gardner TA (2008). Suppression of renal cell carcinoma growth and metastasis with sustained antiangiogenic gene therapy. Hum Gene Ther. 2008 May;19(5):487-95. 73. Ahn M, .Lee, S. J.Li, X.Jimenez, J. A.Zhang, Y. P.Bae, K. H.Mohammadi, Y.Kao, C.Gardner, T. AEnhanced combined tumor-specific oncolysis and suicide gene therapy for prostate cancer using M6 promoterCancer Gene Ther. 2009 Jan;16(1):73-82. Epub 2008 Sep 5. 74. Gardner, T. A.Lee, S. J.Lee, S. D.Li, X.Shirakawa, T.Kwon, D. D.Park, R. Y.Ahn, K. Y.Jung, C. Differential expression of osteocalcin during the metastatic progression of prostate cancer. Oncol Rep. 2009 Apr;21(4):903-8. 75. Gardner TA, Logan T. Prognostic implications of polymorphisms and interleukin-2 therapy for renal cell carcinoma. J Urol. 2009 Aug;182(2):425-6. Epub 2009 Jun 13. 76. Jimenez JA, Li X, Zhang YP, Bae KH, Mohammadi Y, Pandya P, Kao C, Gardner TA. Antitumor activity of Ad-IU2, a prostate-specific replication-competent adenovirus encoding the apoptosis inducer, TRAIL. Cancer Gene Therapy epub date 2009/10/03 77. Bahler CD, Foster RS, Bihrle R, Beck SD, Gardner TA, Sundaram CP, Masterson TA, Cheng L, Koch MO. Radical prostatectomy as initial monotherapy for patients with pathologically confirmed high-grade prostate cancer. BJU Int. 2009 Oct 26 P&T Dossier CV 03/2010 Page 17 Thomas A. Gardner, M. D. 78. Invited Book Chapters, Articles and Reviews (Peer-invited and Non-Peer Reviewed) 1. Young GPH, Li PS, Gardner TA, Goldstein M: Animal models for microsurgical training and research, Chapter 33, In Surgery of Male Infertility, Marc Goldstein (ed.), 1994. 2. Goldstein M, Li PS, Gardner TA: Urologic microsurgery: Training and research, Course Manual, The AUA surgical learning center meeting, Microsurgery, Houston, Texas, 1994. 3. Gardner TA, Theodorescu D. Diagnosis and treatment of prostate cancer. Surg. Sci. Management 3(12): 20-28, 1997 4. Gardner TA, Ko SC, Kao C, Shirakawa T, Cheon J, Gotoh A, Wu TT, Sikes RA, Zhau HE, Cui Q, Balian G, Chung LWK. Exploiting stromal-epithelial interaction for model development and new strategies of gene therapy for prostate cancer and osteosarcoma metastases. Gene Therapy and Molecular Biology 2:41-58, 1998. 5. Gardner TA, Raikwar SP, Kao C, Targeted Adenoviral Vectors II: Transcriptional Targeting, Chapter 9 Adenoviral Vectors for Gene Therapy Editors Curiel & Douglas, Academic Press ,2002. 6. Gardner TA, Transcriptional targeting of Adenoviral Vectors, Science & Medicine May/June 2002. 7. Jimenez JA, Kao C, Lee SJ, Jung C, Gardner TA: Gene Therapy for Prostate Cancer, Chapter 4, Prostate Cancer, Basic Mechanisms and Therapeutic Approaches, Editor Chang, World Scientific Publishing Co., 2005. 8. Gardner TA, Jimenez JA, Chung LWK, Kao C, Antimetastatic Gene Therapy: Prostate Cancer Theory to Therapy, Chapter 20, Cancer Gene Therapy, Editors Curiel & Douglas, Humana Press, 2005. 9. Jimenez JA,LI X, Gardner TA, Kao C: Gene Therapy for Advanced Prostate Cancer, Chapter 9, Prostate Cancer, Biology, Genetics and New Therapuetics, Editors Chung, Isaacs &Simons Humana Press 2007. 10. Jacobsen NB and. Gardner TA: Overcoming the Stigma of Complications of Continent Cutaneous Diversion. Chapter 22 Bladder Cancer: Moving the Field Forward Edited by Lee/Wood, 2009. 11. Jacobsen NB and Gardner TA: Advances in Gene Therapy for Bladder Cancer,Chapter 31,Bladder Cancer: Moving the Field Forward Edited by Lee/Wood, 2009 P&T Dossier CV 03/2010 Page 18 Thomas A. Gardner, M. D. Abstract Poster and Oral Presentations (52 of 97 in rank) 1. Gardner TA. Vascular extension of renal cell carcinoma into the inferior vena cava: An institutional experience. Presented at the Ferdinand C. Valentine Essay Contest, New York Section of the American Urologic Association, New York, NY, March 1993. 2. Gardner TA, Fair WR, Sogani PC, Bains MS, Herr HW, Morse M, Russo P, Sarkis A, Sheinfeld J, Whitmore WF Jr., Burt M. Renal cell carcinoma with inferior vena caval involvement: A Memorial Sloan-Kettering Cancer Center experience. Presented at the 89th annual meeting of the American Urologic Association, San Francisco, CA, May 1994. J Urol 151:262A (Abstract #138). 3. Gardner TA, Li PS, Lopez M, Wright EJ, Goldstein M. Development of a rat model for microsurgical vasoepididymostomy: Effect of vasectomy technique and occlusion time on epididymal dilation. Presented at the 50th annual meeting of the American Fertility Society, San Antonio, TX, November 1994 (Abstract P-244, pS201). 4. Gardner TA, Li PS, Lopez M, Wright EJ, Goldstein M. Microsurgical vasoepididymostomy: A comparison of end to end, end to side, and tubular pull through techniques in the rat. Presented at the 50th annual meeting of the American Fertility Society, San Antonio, TX, November 1994 (Abstract P254, pS205). 5. Gardner TA. Flexible peritoneoscopy for the diagnosis of the contralateral hernia at the time of unilateral pediatric herniorrhaphy. Presented at the Ferdinand C. Valentine Essay Contest, New York Section of the American Urologic Association, New York, NY, March 1995. 6. Gardner TA, Li PS, Eid JF, Goldstein M. Rectal probe electroejaculation for obtaining semen in rats. Presented at the 90th annual meeting of the American Urologic Association, Las Vegas, Nevada, April 1995. J Urol 153:499A, (Abstract #1080). 7. Gardner TA, Hajdu S, Waldbaum R, Badillo F, Steckel J. Can cancer volume on prostate needle biopsies accurately predict the pathological stage of radical prostatectomy specimens? Presented at 93rd Annual meeting of the New York Section of the American Urologic Association, Istanbul, Turkey, October 1995. 8. Gardner TA, Mininberg DT. Update on flexible peritoneoscopy for the diagnosis of the contralateral hernia at the time of unilateral pediatric herniorrhaphy. Presented at 93rd Annual meeting of the New York Section of the American Urologic Association, Istanbul, Turkey, October 1995. 9. Gardner TA, Lemer ML, Schlegel PN, Waldbaum RS, Steckel J, Vaughan ED. Does microfocal prostate cancer on needle biopsy predict pathologic stage or clinical course? Presented at the Sixth International Prostate Cancer Update. Beaver Creek, Colorado, February 1996. 10. Matthews GJ, Gardner TA, Eid JF. In vitro fertilization with intracytoplasmic sperm injection (ICSI) improves pregnancy rates for electroejaculated sperm. Presented at the 91st annual meeting of the American Urologic Association, Orlando, Florida, May 1996. J Urol 155:368A, (Abstract #230). 11. Kao C, Ko SC, Cheon J, Gardner TA, Gotoh A, Shirakawa T, Sikes RA, Karsenty G, Chung LWK. Osteocalcin promoter-based toxic gene therapy for the treatment of osteosarcoma and prostate cancer in experimental models. Presented at the 7th Prouts Neck Meeting on Prostate Cancer: NCI-sponsored Conference on the Biology and Treatment of Prostate Cancer. Prouts Neck, ME, October 1996. 12. Gardner TA, Thornhill KE, Goldstein M. Preoperative prediction of testicular biopsy: Pitting the infertility specialist against the neural network. Presented at the 52nd annual meeting of the American Society for Reproductive Medicine, Boston, MA, November 1996. (Abstract O-98, pS50). 13. Gardner TA, Boyd S, Theodorescu D. Factors determining length of stay after radical prostatectomy: A comparison of perineal and retropubic approach. Presented at the American Cancer Society Annual Regional Meeting of Virginia, Richmond, VA, March 1997. 14. Cheon J, Ko S-C, Gardner TA, Shirakawa T, Kao C and Chung LWK. Chemogene therapy: Osteocalcin promoter based suicide gene therapy in combination with methotrexate in a murine osteosarcoma model. Presented at the American Cancer Society Annual Regional Meeting of Virginia, Richmond, VA, March 1997. P&T Dossier CV 03/2010 Page 19 Thomas A. Gardner, M. D. 15. Gardner TA, Lemer ML, Schlegel PN, Waldbaum R, Vaughan ED Jr., Steckel J. Microfocal prostate cancer: Biopsy volume does not predict actual tumor volume. Presented at the 92nd annual meeting of the American Urologic Association, New Orleans, LA, April 1997. J Urol 157:295 (Abstract #1148). 16. Gardner TA, Kao C, Ko SC, Cheon J, Wu TT, Cui Q, Balian G, Chung LWK. Prostate cancer cell killing using a genetically modified bone stroma cell: Transforming friend to foe with gene therapy. Presented at the 92nd annual meeting of the American Urologic Association, New Orleans, LA, April 1997. J Urol 157:268 (Abstract #1041). 17. Cheon J, Ko SC, Gardner TA, Kao C, Shirakawa T, Chung LWK. Vitamin D3-enhanced osteocalcin promoter-based gene therapy: A novel approach for the treatment of prostate cancer and its metastasis. Presented at the 92nd annual meeting of the American Urologic Association, New Orleans, LA, April 1997. J Urol 157:223 (Abstract #870). 18. Shirakawa T, Cheon J, Ko SC, Gardner TA, Gotoh A, Kao C, Wu TT, Chung LWK. Development of therapeutic toxic gene therapy in experimental models of human prostate cancer bone metastasis: Osteocalcin promoter-based toxic gene therapy. Presented at the 92nd annual meeting of the American Urologic Association, New Orleans, LA, April 1997. J Urol 157:22 (Abstract #86). 19. Gardner TA, Boyd S, Theodorescu D. Factors determining length of stay after radical prostatectomy: A comparison of perineal and retropubic approach. Presented at the 83rd annual clinical congress of the American College of Surgeons, Chicago, IL, October 1997. 20. Kao C, Ko SC, Shirakawa T, Gardner TA, Ou YC, Cheon J, Zhau HE, Chung LWK. Tissue specific toxic gene therapy for androgen-independent human prostate cancers. Presented at the Keystone Symposia on Molecular and Cellular Biology of Gene Therapy, Keystone, CO, January 1998. 21. Sokoloff MH, Gardner TA, Caven TH, Wood A, Chung LWK. Induction of human prostate cancer differentiation by Vitamin-D analogues is attenuated by bone stromal and extracellular matrix cells. Presented at the 1998 International Symposium on Biology of Prostate Growth, NIH, Bethesda, MD, March, 1998 (Proceedings p101). AACR 1998 22. Shirakawa T, Kao C, Ko SC, Gardner TA, Cheon J, Miyamoto T, Gotoh A, Kamidono S, Chung LWK. Intravenous osteocalcin promoter based toxic gene therapy for the suppression of osteosarcoma pulmonary metastasis. Presented at the 89th annual meeting of the American Association for Cancer Research, New Orleans, LA, March 1998. Proceedings of the AACR 39:512 (Abstract #3487). ASGT 1998 23. Gardner TA, Kao C, Shirakawa T, Ko SC, Woo S, Dasarathy Y, Eriksson K, Chung LWK. Adenoviral bystander gene therapy: Cytosine deaminase with 5-flurocytosine is superior over thymidine kinase with acyclovir in the treatment of human renal cell carcinoma in a mouse model. Presented at the 1st annual meeting of the American Society of Gene Therapy, Seattle WA, May 1998 (Abstract #429). 24. Kao C, Kaneda Y, Liu D, Ko SC, Burt M, Ginsberg RJ, Chung LWK, Gardner TA. Locoregional delivery of Ad-CMV-TK combined with ganciclovir is an effective therapy for the treatment of sarcoma pulmonary metastases. Presented at the 1st annual meeting of the American Society of Gene Therapy, Seattle, WA, May 1998 (Abstract #427). 25. Gardner TA, Ko SC, Kao C, Kim SJ, Ou YC, Cui Q, Balian G, Chung LWK. Application of osteoblastic tissue-specific promoter and bone homing mechanism to deliver therapeutic toxic genes for the treatment of prostate cancer metastasis. Presented at the 1st annual meeting of the American Society of Gene Therapy, Seattle, WA, May 1998 (Abstract #432). 26. Ko SC, Gardner TA, Shirakawa T, Cheon J, Miyamoto T, Gotoh A, Chung LWK, Kao C. Effective systemic delivery of adenoviral vectors: targeting pulmonary metastases safely with a tumor-specific promoter. Presented at the 1st annual meeting of the American Society of Gene Therapy, Seattle, WA, May 1998 (Abstract #426). 27. Ko SC, Alden TD, Kim SJ, Sheehan JP, Hankins GR, Gardner TA, Know A, Kao C, Kallmes DF, Cloft HJ, Helm GA. The treatment of malignant meningiomas using osteocalcin promoter based gene therapy. Presented at the 1st annual meeting of the American Society of Gene Therapy, Seattle WA, May 1998 (Abstract #417). AUA 1998 P&T Dossier CV 03/2010 Page 20 Thomas A. Gardner, M. D. 28. Gardner TA, Ko SC, Kao C, Cui Q, Balian G, Chung LWK. Exploiting prostate cancer-bone stromal interaction with gene therapy: Application of osteoblastic tissue-specific promoter and bone homing mechanism to deliver therapeutic toxic genes for the treatment of prostate cancer metastasis. Presented at the 93rd annual meeting of the American Urologic Association, San Diego, CA, June 1998. J Urol 159:4 (Abstract #16). ******1998 AUA Essay Contest Co-First Prize in Research Category**** 29. Sokoloff MH, Gardner TA, Boyd JC, Theodorescu D. Surgical approach and pain management affect length of stay in radical prostatectomy patients. Presented at the 93rd annual meeting of the American Urologic Association, San Diego, CA, June 1998. J Urol 159:301 (Abstract #1161). 30. Shirakawa T, Gardner TA, Kao C, Ko SC, Miyamoto T, Bander NH, Woo S, Chung LWK. Ablative gene therapy of human renal cell carcinoma: Cytosine deaminase plus 5-flurocytosine has superior bystander effect over thymidine kinase plus acyclovir. Presented at the 93rd annual meeting of the American Urologic Association, San Diego, CA, June 1998. J Urol 159:147 (Abstract #558). 31. Ou YC, Gardner TA, Ko SC, Zhau HE, Kao C, Yeung F, Aprikan AG, Chung LWK. Expression of osteocalcin by primary and metastatic prostate cancer and human prostate cell lines: A novel therapeutic target for prostate cancer metastasis. Presented at the 93rd annual meeting of the American Urologic Association, San Diego, CA, June 1998. J Urol 159:2 (Abstract #6). 32. Rhee HW, Chang S, Gardner TA, Chung LWK. Three-dimensional human prostate organoid culture to study cell-cell and cell-matrix interaction: Irreversible alterations of prostate epithelial tumorigenicity, growth responsiveness to androgen and estrogen, and growth factors in culture. Presented at the 93rd annual meeting of the American Urologic Association, San Diego, CA, June 1998. J Urol 159:5 (Abstract #17). 33. Cheon J, Kim JJ, Koh SK, Ko SC, Gardner TA, Kao C, Chung LWK. Adenovirus-mediated suicide gene therapy for the treatment of orthotopic murine bladder tumors. Presented at the 93rd annual meeting of the American Urologic Association, San Diego, CA, June 1998. J Urol 159:284 (Abstract #1093). 34. Gardner TA, Cui Q, Kao C, Ko S-C, Cheon J, Wu TT, Chung LWK, Balian G. Pluripotential cells form bone marrow stroma deliver therapeutic genes to bone metastases. Presented at the 45th annual meeting of the Orthopaedic Research Society, Anaheim, CA, February 1999. KUA 1998 35. Cheon J, Kim HK, Shim GS, Kim YS, Koh SK, Ko SC, Gardner TA, Kao C, Chung LWK. Development of novel medical prostatectomy for the treatment of benign prostatic hyperplasia: Change of Histopathological tumor markers and effect on prostrate volume. Korea Urological Association, 1998, Seoul Korea. AACR 1999 36. Wada Y, Gardner TA, Ko SC, Kao C, Kim SJ, Shirakawa T, Chung LWK. Widening the therapeutic window of thymidine kinase/GCV gene therapy with a tumor-restricted promoter: Osteocalcin based TK gene therapy for osteosarcoma. Minisymposium presentation at the 90th annual meeting of the AACR, Philadelphia,PA, April 1999. Proceedings of the AACR 40:87 (Abstract #579). AUA 1999 37. Cheon J, Kim HK, Shim GS, Koh SK, Ko SC, Gardner TA, Zhau HE, Kao C, Chung LWK. Ablation of murine prostate utilizing ad-oc-tk/gcv treatment: a potential molecular therapy for the treatment of benign prostatic hyperplasia. Presented at the 94th annual meeting of the American Urologic Association, Dallas, TX, May 1999. J Urol 161:305 (Abstract #1174). 38. Cheon J, Moon DG, Kim JJ, Kim HK, Koh SK, Ko SC, Gardner TA, Kao C, Chung LWK, Woo SL. Effect of adenovirus-mediated suicde gene therapy on long-term host survival in an orthotopic murine bladder tumor model. Presented at the 94th annual meeting of the American Urologic Association, Dallas, TX, May 1999. J Urol 161:115 (Abstract #435). 39. Shirakawa T, Gotoh A, Fujisawa M, Okada H, Arakawa S, Kamidono S, Gardner TA, Wada Y, Kao C. Development of human chorionic gonadotoropin subunit ß (ß-hcg) promoter-based toxic gene therapy for testicular germ cell tumor. Presented at the 94th annual meeting of the American Urologic Association, Dallas, TX, May 1999. J Urol 161:183 (Abstract #706). P&T Dossier CV 03/2010 Page 21 Thomas A. Gardner, M. D. 40. Shirakawa T, Matsubara S, Gotoh A, Fujisawa M, Okada H, Arakawa S, Kamidono S, Gardner TA, Wada Y, Ko SC, Kao C. Molecular therapy with recombinant wt-p53 adenovirus for the treatment of benign prostatic hyperplasia in human cells and rat experimental models. Presented at the 94th annual meeting of the American Urologic Association, Dallas, TX, May 1999. J Urol 161:359 (Abstract #1391). 41. Ou YC, Yeung F, Yang L, Kao C, Chung LWK, Gardner TA. MN promoter activity in renal cell carcinoma cell lines: a potential for tissue restrictive gene therapy. Presented at the 94th annual meeting of the American Urologic Association, Dallas, TX, May 1999. J Urol 161:145 (Abstract #554). 42. Kim SJ, Gardner TA, Ko SC, Kao C, Balian G, Chung LWK. Enhancement of bystander prostate cancer cell killing by the utilization of genetically engineered bone stromal cells that confer either cytosine deaminase or thymidine kinase gene. Presented at the 94th annual meeting of the American Urologic Association, Dallas, TX, May 1999. J Urol 161:58 (Abstract #217). 43. Ou YC, Gardner TA, Ko SC, Zhau HE, Kao C, Chung LWK, Water D. Expression of osteocalcin in canine metastatic prostate cancer : an ideal prostate cancer animal model for osteocalcin promoter-based toxic gene therapy.Presented at the 94th annual meeting of the American Urologic Association, Dallas, TX, May 1999. J Urol 161:130 (Abstract #498). 44. Caven TH, Sokoloff MH, Chang SM, Gardner TA, Wood A, Chung LWK. Inhibition of human prostate cancer growth by vitamin-D analogues is attenuated by increaseds in stromal and extracellular matrix factors. Presented at the 94th annual meeting of the American Urologic Association, Dallas, TX, May 1999. J Urol 161:296 (Abstract #1136). 45. Eriksson K, Gardner TA, Dasarathy Y. Purification of adenoviral vectors using anion exchange chromatography. Presented at the 19th International Symposium on the Separation of Proteins, Peptides and Polynucleotides, Delray Beach, FL, October-November 1999. 46. Ou, T-c, Yeung F, Kao C, Chung LWK, Gardner TA. Expression of MN in renal cell carcinoma cell lines: A potential for tissue restrictive gene therapy. Presented at the First International Kidney Cancer Symposium, Chicago, IL, October 1999. 47. Gardner TA, Wada Y, Shirakawa T, Ko S-C, Kao C, Kim SJ, Yang L, Chung LWK. Osteocalcin promoter restricted adenoviral replication as a potential treatment of prostate cancer metastasis. Presented at the 8th International Conference on Gene Therapy of Cancer, San Diego, CA, December 1999. **************1999 Vical Best Abstract Award ************ ASGT 2000 48. Gardner TA, Chung LWK, Koenemen K, Gillenwater JY, Myers C, Fisch M, Kallmes D, Wada Y, Yang, L, Kao, C. Preliminary safety report of an osteocalcin-based adenoviral gene therapy (Ad-OC-TK) for metastatic and recurrent prostate cancer: Tumor-restrictive promoter confers safety of toxic gene expression. Presented at 3rd annual meeting of the American Society of Gene Therapy, May 2000. Mol Therapy 1(5):S236 (Abstract # 649). 49. Matsubara S, Wada Y, Hsieh CL, Gardner TA, Shirakawa T, Gotoh A, Kao C, Kamidono S, Chung LWK. Tissue-specific osteocalcin (OC) promoter-based replication-competent adenovirus gene therapy for human prostate cancer skeletal metastasis models. Presented at 3rd annual meeting of the American Society of Gene Therapy, May 2000. Mol Therapy 1(5):S151 (Abstract # 390). 50. Koeneman KS, Gardner TA, Chung LWK, Masik GB. Mechanism of elevated aPT during administration of adenoviral vectors for gene therapy. Presented at 3rd annual meeting of the American Society of Gene Therapy, May 2000. Mol Therapy 1(5):S54 (Abstract # 108). NCS 2000 51. Gardner TA, Sanghvi NT, Koch MO, Bihrle R, Foster R Improved Prostatic Ablation using a Split Beam Modification of the High Intensity Focused Ultrasound(HIFU).”, Proceeding of 74th Annual North Central Section of AUA, p49. 52. Gardner TA, Koeneman K, Gillenwater J, Koch M, Chung LWK, Kao C “Osteocalcin Based Gene therapy for the treatment of Metastatic Prostate Cancer. Phase I results and Phase II trial Design.”. Proceeding of 74th Annual North Central Section p75. ASGT 2001 P&T Dossier CV 03/2010 Page 22 Thomas A. Gardner, M. D. 53. Gardner TA, Shalhav M, Kim HS, Ou YC, Kin SJ, Kao C “Preclinical Evaluation of Renal Cell Carcinoma Specific-Oncolysis using MN Promoter Mediated Transcriptional Targeting”,” Molecular Therapy 3(5):S348,2001. AUA 2001 54. Matsubara S, Wada Y, Gardner TA, Hsieh CL, Zhau HE, Kao C, Gillenwater JY, Chung LWK, Kamidono S. ``Systemic Osteocalcin (OC) Promoter-Driven replication-competent Adenovirus for the treatment of androgen-independent prostate cancer bone metastasis.” J Urol 165(5):S45,2001( Abstract #183) 55. Cheon J, Park HS, Bae JH, Moon DG, Kim JJ, Cho HY, Gardner TA, “In-vivo characterization of a prostate specific antigen promoter-based suicide gene therapy for the treatment of benign prostatic hyperplasia” J Urol 165(5):S113,2001( Abstract #462) 56. Masterson T, Koch MO, Foster R, Bihrle R, Wahle G, Gardner TA, Cheng L. “Does more extensive prostate sampling more accurately predict tumor characteristics” J Urol 165(5):S241,2001( Abstract #992) 57. Gardner TA, Koch MO, Shalhav A, Bihrle R, Foster R, Murphy J, Rao VV, Sanghvi N, Resnick MI, Seftel AD, Grunberger I, Steidel CP, Corhran JS. “High intensity focused ultrasound (HIFU) for the treatment of BPH: Interim results of A Multicenter phase III study.” J Urol 165(5):S369,2001( Abstract #1512) 58. Raikwar SP, Sandoval R, Moghaddam M, Molitoris B, Kao C, Gardner TA. Intravital dual photon confocal optical imaging of a fluorescent prostate tumor model. New Discoveries in Prostate Cancer Biology and Treatment (AACR Sponsored) Abstract # NCS 2001 59. Shalhav Al, Stevens LH, Gardner TA, Koch MO, Lingeman JE, “Factors recommended to improve laparoscopic donor nephrectomy outcomes” Proceeding of 75th Annual North Central Section p101. 60. Shalhav Al, Stevens LH, Gardner TA, Lingeman JE, “Modified pfannenstiel for manual specimen retrieval without a pneumoperitoneum preserving device following pure laparoscopic live donor nephrectomy.” Proceeding of 75th Annual North Central Section p103. 61. Zhang S, Goebl MG, Harrington MA, Gu J, Kao C, Gardner TA, Eble JN, Cheng L: MyoD expression blocks tumor initiation in the murine RM-9 prostate tumor model. Presented at the 2001 annual meeting of the United States and Canadian Academy of Pathology in Atlanta, GA. Modern Pathol 14:130A, 2001. 62. Zhang S, Gu J, Wilkes DS, Woods K, Kao C, Gardner T, Eble JN, Cheng L: Tumor extract pulsed IL-12 stably transfected dendritic cells blocked the formation of prostatic carcinoma in vivo. Presented at the 2001 annual meeting of the United States and Canadian Academy of Pathology in Atlanta, GA. Modern Pathol 14:130A, 2001. 63. Zhang S, Gu J, Kao C, Gardner T, Eble JN, Cheng L: IL-12 antitumor effect is mediated by Fas-Fas ligand induced apoptosis. Presented at the 2001 annual meeting of the United States and Canadian Academy of Pathology in Atlanta, GA. Modern Pathol 14:131A, 2001. 64. Raikwar S.P., Sandoval, R.M., Moghaddam, M., Molitoris, B.A., Kao, C. and Gardner, T.A. (2001): Intravital dual photon Confocal optical imaging of a fluorescent prostate tumor model. New Discoveries in Prostate Cancer Biology and Treatment. Naples, Florida, December 2001. ***American Association for Cancer AACR-Astra-Zeneca Scholar-intraining award (2001)*** AACR 2001 65. Zhang S, Gu J, Kao C, Gardner TA, Eble JN, Cheng L: Fas-Fas ligand mediated apoptosis in IL-12 induced rejection of prostate tumor. Presented at the 92nd annual meeting of the American Association for Cancer Research in New Orleans, LA. Proc Am Assn Cancer Res 42:72; 2001. 66. Cheng L, Zhang S, Goebl MG, Harrington MA, Gu J, Kao C, Gardner TA, Eble JN: MyoD expression blocks tumor initiation in the murine RM-9 prostate tumor model. Presented at the P&T Dossier CV 03/2010 Page 23 Thomas A. Gardner, M. D. 92nd annual meeting of the American Association for Cancer Research in New Orleans, LA. Proc Am Assn Cancer Res 42:72; 2001. ASGT 2002 67. Lee S-J, Kim H-S, Rong Y, Gardner TA, Kao C. “Novel Chimeric Prostate-Specific Promoter, PSESBased Suicide Gene Therapy Demonstrates Specific Killing in Human Prostate Cancer Cells”," 5th Annual Meeting of the American Society of Gene Therapy, June 8, 2002, Boston, Massachusetts. 68. 463] Development of a Novel Adenoviral Vector for Real Time Monitoring of VP22 Mediated Intercellular Trafficking in Prostate, Renal and Breast Cancer Cell Lines Sudhanshu P. Raikwar, Chinghai Kao, Thomas A. Gardner. 5th Annual Meeting of the American Society of Gene Therapy, June 8, 2002, Boston, Massachusetts. 69. Kubo H, Gardner TA, Gotoh A, Koeneman KA, Lim S, AminMB, Gillenwater JW, Yang H, Wada Y, Nakagawa M, Kao C, Zhau HE, Chung LWK. UrologyCorrelation of Therapeutic Responses with Tumor Associated Parameters: A Phase I Clinical Trial of Adenovirus Osteocalcin Promoter Driven Herpes Simplex Virus Thymidine Kinase (Ad-OC-TK) for Metastatic and Localized Hormone Refractory Prostate Cancer[Oral #1174] 5th Annual Meeting of the American Society of Gene Therapy, June 8, 2002, Boston, Massachusetts. 70. Gardner TA, Brandli DW, Shalhav M, Shalhav T, Kim HS, Kao C. Renal Cell Carcinoma-Specific Oncolysis Mediated by MN-Promoter Based Transcriptional Regulation of Adenoviral E1a Protein[Poster1285] 5th Annual Meeting of the American Society of Gene Therapy, June 8, 2002, Boston, Massachusetts. 71. Gardner TA, Raikwar SP, Krasnykh V, Kao C. Combining Transductional-Targeting with TranslationalTargeting for Prostate Cancer Adenoviral-Mediated Oncolytic Effect 653] 5th Annual Meeting of the American Society of Gene Therapy, June 8, 2002, Boston, Massachusetts. 72. Raikwar SP, Sandoval RM, Kim HS, Kao C, Molitoris BA, Gardner TA. Intravital Confocal Fluorescence Optical Imaging of VP22-Mediated Intercellular Trafficking and Tumor Vasculature Targeting in the Prostate Tumor Models. oral #1189 at 5th Annual Meeting of the American Society of Gene Therapy, June 8, 2002, Boston, Massachusetts. AUA 2002 73. Brandli DW, Shalhav M, Shalhav T, Kim H-S, Kao C, Gardner TA. MN-Based transcriptional regulation of adenoviral early proteins provides renal cell carcinoma-specific oncolysis. J Urol 167(4):S132, 2002 (AUA 2002 Abstract #529). 74. Shalhav Al, Siqueira TM, Stevens LH, Gardner TA, Lingeman JE, Koch ME “A Modified pfannenstiel incision for manual retrieval without a pneumoperitoneum-preserving device following pure laparoscopic live donor nephrectomy.” J Urol 167(4):S394, 2002(AUA 2002 Abstract #v1569). ****Best Video Award – Honorable Mention**** ISTU 2002 75. Uchida T, Sanghvi NT, SatohT, Irie A, Omata T, Baba S, Koch MO, Gardner TA, "Transrectal High Intensity Focused Ultrasound for the Treatment of Localized Prostate Cancer," Proc. of the International Symposium on Therapeutic Ultrasound, 2002. 76. Sanghvi NT, Uchida T, Koch MO, Gardner TA, "Total Prostate Ablation for the Treatment of Localized Prostate Cancer Using Image Guided HIFU," presented at the 2002 IEEE Ultrasonics Symposium. 77. R. Seip, N.T. Sanghvi, R. Carlson, J. Tavakkoli, K. Dines, T.A. Gardner, and T. Uchida, "Sonablate®500: A Novel Platform for Transrectal Image-Guided HIFU Treatment of Localized Prostate Cancer," presented at the 32nd Annual Symposium of the Ultrasonic Industry Association (UIA), 2002. AACR 2002 78. Cheng L, Jiang J, Zhang S, Kao, C, Gardner TA, Eble JN: Fas and Fas ligand expression is elevated in prostatic intraepithelial neoplasia and prostatic adenocarcinoma. Presented at the 93nd annual meeting of the American Association for Cancer Research in San Francisco, CA. Proc Am Assn Cancer Res 43:1 (abstract No. 3A); 2002. ISTU 2003 P&T Dossier CV 03/2010 Page 24 Thomas A. Gardner, M. D. 79. J. Tavakkoli, A. Mehta, C. Miller, R. Seip, N.T. Sanghvi, L. Cheng, T.A. Gardner, and A.L. Shalhav, "A Laparoscopic HIFU Probe with Integrated Phased Array Ultrasound Imaging," to appear in the International Symposium on Therapeutic Ultrasound, 2003. 80. R. Seip, D. Shaeffer, P. Lawrence, T.A. Gardner, M.O. Koch, L. Cheng, A. Wunderlich, C. Miller, and N.T. Sanghvi, "Feasibility Study for the Treatment of Brachytherapy Failure Prostate Cancer using HighIntensity Focused Ultrasound," to appear in the International Symposium on Therapeutic Ultrasound, 2003 AUA 2003 81. Lee S, Kim HS, Jung C, Gardner TA, Kao C. NFATC1 with AP-3 site binding specificity mediates gene expression of prostate specific membrane-antigen. AUA 2003 #207P 82. Gardner TA,Lee SJ, Mosharafa A, Lee X, Yu R, Cheng L, Kim HS, Jung C, Kao C. Generation of a Prostate-restricted replication competent adenovirus using a chimeric prostate specific promoter AUA #830. 83. Kubo H, Gardner TA, Wada Y, Koeneman KS, Gotoh A, Ling Y, Kao C, Lim SD, Amin MB, Yang H, Black ME, Matsubara S, Nakagawa M, Gillenwater JY, Zhau HE, Chung LWK. Phase I dose-escalation clinical trial of adenoviral osteocalcin promoter driven herpes simplex virus thymidine kinase in localized and metastatic hormone refractory prostate cancer #940 84. Gardner TA, Koch MO, Shalhav AL, Foster RS, Bihrle R, Resnick MI, Seftal AD, Grunberger I, Steidle CP, Cochran JS, Sanghvi NT. Phase III multicenter study of high intensity focused ultrasound (HIFU) for the treatment of benign prostatic hypertrophy (BPH): Final Analysis.:Abstract 1453 oral ASGT 2003 85. Raikwar SP, Gardner TA, Kao C. Antiangiogenic gene therapy targeting the endothelium-specific Flk-1 and Tie-2: Inhibition of tumor angiogenesis and growth in prostate cancer. ASGT 2003 #337, Molecular therapy 7(5): S132, 2003. 86. Gardner TA, Zhang Y, Lee SJ, Kim HS, Kao C. Replication-competant adenovirus targeting prostate using PSMA enhancer. ASGT 2003 #936, Molecular therapy 7(5): S360, 2003. 87. Raikwar SP,Kao C, Gardner TA. An adenoviral vector expressing a novel chimeric endostatinangiostatin gene inhibits angiogenesis and tumor growth in prostate cancer. ASGT 2003 #1112, Molecular therapy 7(5): S428, 2003. APA 2004 88. Armatys S, Koch MO, Bihrle R, Gardner TA, Eble JN, Patel NB, Daggy JB, Cheng L: A clinicopathologic comparison of clinical sages T1c versus T2 prostate adenocarcinoma: lack of difference in PSA recurrence. Presented at the 2004 annual meeting of the United States and Canadian Academy of Pathology in Vancouver, B.C., Canada. Modern Pathol 17: 573A, 2004. 89. Bunde PJ, Koch MO, Bihrle RA, Gardner TA, Eble JN, Daggy J, Cheng L: Preoperative PSA is correlated with tumor volume and prostate weight and predictive of PSA recurrence. Presented at the 2004 annual meeting of the United States and Canadian Academy of Pathology in Vancouver, B.C., Canada. Modern Pathol 17: 596A, 2004. 90. Hong H, Kao C, Jeng M, Eble JN, Koch MO, Gardner TA, Zhang S, Li L, Hu Z, MacLennan GT, Cheng L: Overexpression of CARM1, a transcriptional coactivator of androgen receptor, in prostatic adenocarcinoma and its precursors. Presented at the 2004 annual meeting of the United States and Canadian Academy of Pathology in Vancouver, B.C., Canada. Modern Pathol 17: 660A, 2004. 91. Sweeney C, Li L, Bhat-Nakshatri P, Baldridge LA, Zhang S, Gardner T, Kao C, Koch MO, Nakshatri H, Cheng L: Nuclear factor kappa b is constitutively activated in prostate cancer in vitro and is increased in prostatic intra-epithelial neoplasia and adenocarcinoma of the prostate. Presented at the 2004 annual meeting of the United States and Canadian Academy of Pathology in Vancouver, B.C., Canada. Modern Pathol 17: 750A, 2004. AUA 2004 P&T Dossier CV 03/2010 Page 25 Thomas A. Gardner, M. D. 92. Gardner TA, Raikwar SP, Lee SJ, Bunde PJ, Xiong L, Kao C. Ad-PSES –TRAIL: A novel Prostate specific TRAIL over-expressing adenoviral vector for androgen independent prostate cancer gene therapy. AUA 2004 # 616P 93. Bunde PJ, Koch MO, Bihrle R, Gardner TA, Eble JN, Daggy JK, Cheng L. Preoperative prostatic specific antigen is correlated with tumor volume and prostate weight and predictive of biochemical recurrence. (AUA 2004 # 1263 Oral) 94. Zeng G, Hu Z, Zhang S, Li L, Baldridge LA, Kao C, Gardner TA, Koch MO, Ulbright TM, Eble JN, Cheng L. EPHA2: A novel target for prostate cancer treatment. (AUA 2004 #1823 P) ASGT 2004 95. Toshiro Shirakawa, Nobuyuki Hinata, Shuji Terao, Katsumi Shigemura, Naonori Taniguch, Kazuhito Fukushima, Khoji Sugimoto, Kazuro Sugimura, Masafumi Matsuo, Sakan Maeda, Sadao Kamidono, Chinghai Kao, Thomas A. Gardner, Leland W. K. Chung, Akinobu Gotoh. Phase I/II Clinical Trial of Ad-OC-TK plus VAL for the Patients with Metastatic or Local Recurrent Prostate Cancer: Initial Experience in Japan7th Annual American Society of Gene Therapy, June 4, 2004, Minneapolis, Minnesota (Poster #604). Molecular Therapy 9 (1): S228, 2004. 96. Sudhanshu P. Raikwar, Chinghai Kao, Thomas A. Gardner Synergy between Angiostatin-Endostatin and Tie-2: A Novel Anti-Angiogenic Gene Therapy for Prostate Cancer ,7th Annual American Society of Gene Therapy, June 5, 2004, Minneapolis, Minnisota(Poster #966). Molecular Therapy 9 (1): S369,2004. 97. Sudhanshu P. Raikwar, Thomas A. Gardner, Chinghai Kao. VP22 Mediates Tumor Vasculature Specific Targeting 7th Annual American Society of Gene Therapy, June 6, 2004, Minneapolis, Minnesota (Oral Abstract #1021) Molecular Therapy 9 (1): S391,2004. ASGT 2005 (St-Louis) 98. Xiong Li, Yang Ping Zhang, Hong-Sup Kim, Kyung-Hee Bae, Keith M. Stantz, Sang-Jin Lee, Chaeyong Jung, Jaun A. Jimenez, Thomas A. Gardner, Meei-Huey Jeng, Chinghai Kao. Gene therapy for prostate cancer by controlling Adenovirus E1a and E4 Gene Expression with PSES. 8th Annual American Society of Gene Therapy, June 6, 2005, St. Louis, Missouri,(Oral Abstract #1009) Molecular Therapy 9 (1): S391,2005. ASGT 2006 (Baltimore) 99. Xiong Li, Sudhanshu P. Raikwar, You-Hong Liu, Sang-Jin Lee, Yan-Ping Zhang, Shaobo Zhang, Liang Cheng, Sang-Don Lee, Beth Elisa Juliar, Thomas A. Gardner, Meei-Huey Jeng, Chinghai Kao. Combination Therapy of Androgen-Independent Prostate Cancer Using a Prostate Restricted Replicative Adenovirus and a Replication-Defective Adenovirus Encoding Human Endostatin-Angiostatin Fusion Gene (Oral Abstract #433) AUA 2006 Alanta Vol. 558 175, No. 4, Supplement 100.Pratik Desai, Chandru P Sundaram, Xianhui Su, Thomas A Gardner, Michael Koch. ROBOTIC ASSISTED LAPAROSCOPIC PROSTATECTOMY VS. OPEN RADICAL RETROPUBIC PROSTATECTOMY: CHARACTERISTICS OF PATHOLOGIC POSITIVE SURGICAL MARGIN Discussed Poster #1161 May 23, 2006 AUA 2007 101.Xiong Li, Sudhanshu P Raikwar, Sang-Jin Lee, Hong-Sup Kim, Shaobo Zhang, Thomas A Gardner, Meei-Huey Jeng, Chinghai Kao. COMBINATION THERAPY OF ANDROGEN-INDEPENDENT PROSTATECANCER USING A PROSTATE RESTRICTED REPLICATIVE ADENOVIRUS AND A REPLICATION DEFICIENT ADENOVIRUS ENCODING HUMAN ENDOSTATIN-ANGIOSTATIN FUSION PROTEIN Discussed Poster#806, May 22, 2006. 102.Matthew J Mellon*, Miwon Ahn, Yan-Ping Zhang, Juan A Jiménez, Chinghai Kao, Thomas A Gardner ANTIANGIOGENIC GENE THERAPY FOR METASTATIC RENAL CELL CARCINOMA PRODUCES TUMOR GROWTH SUPPRESSION IN AN ATHYMIC NUDE MOUSE MODEL Podium Session at the 2007 Annual Meeting of the American Urological Association Education and Research Anaheim, CA, May 19-24, 2007. AACR 2007 P&T Dossier CV 03/2010 Page 26 Thomas A. Gardner, M. D. 103.Matthew J Mellon*, Miwon Ahn, Yan-Ping Zhang, Juan A Jiménez, Chinghai Kao, Thomas A Gardner Metastatic renal cell carcinoma tumor growth suppression using adenoviral vectors expressing endostatinangiostatin fusion protein 2007 AACR Annual Meeting. 104. P&T Dossier CV 03/2010 Page 27 Thomas A. Gardner, M. D. P07-2 0807-01 Dendreon D9902 0308-23 Dendreon Corp. PB01 0308-24 Dendreon Corp. P09-1 Dendreon COU-AA302 P09-2 Gardner, Thomas CLOSED TO ACCR consented, 16 enro LTFU, 12 for F/U, 2 process of screenin Gardner, Thomas CLOSED TO ACCR follow for LTFU blo Gardner, Thomas Gardner, Thomas CLOSED TO ACCR Ferring A Prospective Multicenter Registry of Salvage Cryotherapy in Recurrent Prostate Cancer Study the "Cold Registry" An Open-Label, Multi-Center, Randomized, Parallel-Arm One-Year Trial, Comparing the Efficacy and Safety of Degarelix Three Month Dosing Regimen with Goserelin Accetate in Patient with Prostate Cancer Requiring Androgen Deprivation Therapy Cougar Technology A Phase 3, Randomized, Double-Blind, PlaceboControlled Study of Abiraterone Acetate (CB7630) Plus Prednisonee in Asymptomatic or Mildly Symptomatic Patients with Metastatic CastrationResistant Prostate Cancer Gardner, Thomas Dendreon An Open-Label Study of Sipuleucel-T in Men with Metastatic Castrate Resistant Prostate Cancer Gardner, Thomas Pre-selection visit l Still waiting for the the protocol. In the process of o Support from Dr. H submitted to CTO a on the budget Koch, Michael This study will start CLOSED TO ACCR being follwed LTFU Foster, Richard Close to accrual 3 intervention and int Endocare no funding FE 200486 CS35 A Randomized, Multicenter, Single Blind Study in Men with Metastatic Androgen Independent Prostate Cancer to Evaluate Sipuleucel-T Manufactured with Different Concentration of PA2024 Antigen A Randomized, Double Blind, Placebo Controlled Phase 3 Trial of Immunotherapy With Autologous Antigen Presenting Cells Loaded With PA2024 (Provenge, APC8015) in Men with Metastatic, Androgen Independent Prostatic Adenocarcinomas An Open Label, Single Arm Trial of Immunotherapy With Autologous Antigen Presenting Cells Loaded with PA2024 (APC8015F) for Subjects with Objective Disease Progression and Disease-Related Pain on Protocol D9902 Part B An Open-Label Study of Sipuleucel-T in Men with Metastatic Castrate Resistant Prostate Cancer Gardner, Thomas open to accrual, 1 Gardner, Thomas Pre-selection visit l waiting for the ackn protocol. Koch A Phase 4, Multicenter, Double-Blind, PlaceboControlled, Parallel Study of Alvimopan for the Management of Postoperative Ileus in Subjects Undergoing Radical Cystectomy 20090507 S2000 SWOG Selenium and Vitamin E Cancer Prevention Trial. Foster 0007-06 NIH P&T Dossier CV 03/2010 Pilot Study: Cox-2 Inhibitor in Invasive Bladder Cancer. Page 28 Thomas A. Gardner, M. D. Treatment Preferences and Health Outcomes in Men With Clinically Localized Prostate Cancer. A Prospective Cohort Study From the Prostate Cancer Intervention Versus Observation Trial (PIVOT) Registry Foster, Richard Close to accrual, th but still submits for 0704-79 Randomized Controlled Trial Examining the Return of Urinary Continence After RobotAssisted Radical Prostatectomy with or Without a Urethrovesical Sling Comparison of Laparoscopic Versus HandAssisted Laparoscopic Donor Nephrectomy Outcomes After Robotic-Assisted Laparoscopic Pyloplasty Prospective Study of Laparoscopic Renal and Adrenal Surgery The Effect of Robot Assisted Surgery on Patient Selection of Urologic Treatments Database of Patients Undergoing Kidney and Adrenal Surgery Chandru Sundaram Chandru Sundaram Chandru Sundaram Chandru Sundaram Chandru Sundaram IRB has been appr received the contra (Marv Andrews has multiple times) nee Do Continuing Sub Amendments to IR Do Continuing Sub Amendments to IR Do Continuing Sub Amendments to IR Do Continuing Sub Amendments to IR Do Continuing Sub Amendments to IR EX0403-34 Review of Laparoscopic Donor Nephrectomy and Recipient Outcomes: The Indiana University Experience Chandru Sundaram Do Continuing Sub Amendments to IR Stephen Beck Do Continuing Sub Amendments to IR 9903-35 Sundaram 0806-53 Cooks Medical 0309-24 0309-52 0606-22 0610-64 Beck 0807-63 P&T Dossier CV 03/2010 Gene Expression Profiling-Based Prediction of Systemic Metatases in Clinical Stage A Nonseminom Germ Cell Tumors Page 29 Thomas A. Gardner, M. D.