RONALD F. TUTRONE, JR., MD,FACS,CPI Chesapeake Urology Associates

RONALD F. TUTRONE, JR., M.D.,FACS,CPI Chesapeake Urology Associates/ Partner Chesapeake Urology Research Associates/ Medical Director 6535 North Charles Street, PPN Suite #’s 625 & 650 Towson, MD 21204

6820 Hospital Drive, Suite #210 8322 Bellona Avenue, Suite #’s 202 & 390 Baltimore, MD 21237 Towson, MD 21204

7580 Buckingham Blvd. Suite # 110 21 Crossroads Drive, Suite #’s 220 & 200 Hanover, MD 21076 Owings Mills, MD 21117

2 Park Center Court, Suite #A Owings Mills, MD 21117

PERSONAL Date of Birth: November 27, 1961 Place of Birth: Brooklyn, NY

EDUCATION 9/79-5/83 College of the Holy Cross, Worcester, MA B.A. Chemistry

8/83-6/87 UMDNJ-Rutgers Medical Piscataway, NJ Doctor of Medicine

GENERAL SURGERY 7/87-6/88 Kings County Hospital/SUNY-Downstate Medical Center Brooklyn, NY Internship

7/88- 6/89 Kings County Hospital/SUNY-Downstate Medical Center Brooklyn, NY Resident in General Surgery

UROLOGY RESIDENCY TRAINING Harvard Program in Urology (Longwood Area) 7/89-9/93 Brigham and Women’s Hospital, Beth Israel Hospital, The Children’s Hospital, Dana-Farber Cancer Institute, West Roxbury Veteran’s Hospital Boston, MA Resident in Urological Surgery

7/90-6/91 Hartwell Harrison Urologic Research Laboratory Harvard Medical School, Boston, MA Urologic Research Fellow

WORK HISTORY 1997- Present Chesapeake Urology Associates, Partner Chesapeake Urology Research Associates, Medical Director 6535 North Charles St Suite 625 PPN Towson, MD 21204

1995 - 1997 Siegel & Langer, M.D., P.A. 21 Crossroads Drive Suite 345 Owings Mills, MD 21117

1993 - 1995 The Urology Center Towson, MD 21204

BOARD CERTIFCIATION/ LICENSURE AND GENERAL CERTIFICATION

American Board of Urology Certified: March 24, 1995 Re-Certified: November 2003, November 2013 Certificate #11119

CPI- Certified Principal Investigator November 2012 Renewal November 2016

HOSPITAL AFFILIATIONS Greater Baltimore Medical Center St. Joseph Medical Center Union Memorial Hospital

NOTEWORTHY HONORS AND AWARDS Washington Post Super Doc 2012,2013 Baltimore Magazine, “Top Doc” 2000,2004,2008,2010,2011,2012,2013,2014,2015,2016 Resident Essay Contest, First Prize 1991 AUA New England Section, Dixville Notch, NH Basic Science Research, Second Prize 1991 Annual Resident Research Competition Harvard/Countway Urology Rounds Alpha Omega Alpha-Rutgers Medical 1987 Phi Beta Kappa-Holy Cross 1983 Cum Laude- Holy Cross 1983 Dean’s List Four Consecutive Years 1979-1983 Memorial Sloan-Kettering Cancer Center/ 1982 Roche Institute of Molecular Biology Research Scholarship Memorial Sloan-Kettering Cancer Center/ 1981 Roche Institute of Molecular Biology Research Scholarship

MEDICAL SOCIETIES American College of Surgeons, Fellow American Urological Association, Member Maryland Urological Association, Member

ACADEMIC APPOINTMENTS Harvard Medical School, Clinical Fellow in Surgery 07/89-06/1993 Union Hospital of Cecil County, Chief of Surgery 01/98-01/2000 Eli Lilly Scientific Advisory Board for Duloxetine 10/02-01/2004 GlaxoSmithKline National Advisory Board for Avodart 07/03-07/2008 GBMC Foundation Board Member 01/2004-01/2006

Surgical Advisory Committee, GBMC 07/1999-07/2012 Medical Director, Baltimore Lithotripsy Associates 01/2000-7/2014 Chief of Urology-Greater Baltimore Medical Center 01/2006-Present GBMC Hospital Board Member 04/2006-01/2013 Chairman of William E. Kahlert Endowment for Urological Research 01/2007-Present Vice President, William E. Kahlert Foundation 03/2010-Present

COURSE FACULTY Laparoscopic Urologic Surgery 4/3-5/1992 Office of Continuing Medical Education Harvard Medical School and Division of Urology Brigham and Women’s Hospital

Pediatric Endourology and Laparoscopic Surgery 4/1-4/1993 Office of Continuing Medical Education Harvard Medical School and Division of Urology The Children’s Hospital

Management of Urinary Incontinence 6/24/1995 Greater Baltimore Medical Center 6/14/1997 Course Co-Director

Advanced Management of Urinary Incontinence 10/16-18/1998 Boca Raton, FL Course Co-Director

Management of Complex Urinary Incontinence 4/25-26/2003 and Pelvic Organ Prolapse Baltimore, MD Course Co-Director

Surviving Cancer in the 21st Century 2/21/2009 Speaker

PATENTS Inflatable Vaginal Pessary, U.S. Patent # 5,603,685

Inflatable Vaginal Pessary, U.S. Patent # 5,611,768

PUBLICATIONS

Rathkopf D, Antonarakis E, Shore N, Tutrone RF, Alumkal J, Ryan C, Saleh M, Hauke R, Bandekar R, Chow Maneval E, de Boer C, Yu M, Scher H: Safety and Antitumor Activity of Apalutamide (ARN-509) in Metastatic Castration-Resistant Prostate Cancer Patients with and without Prior Abiraterone Acetate and Prednisone January 2017

Rukstalis D, Rashid P, Bogache W, Tutrone RF, Barken J, Chin P, Woo H, Cantwell A, Cowan B, Bolton, D: 24-month durability after crossover to the prostatic urethral lift from randomised blinded sham BJU International 118; 14-22, October 2016

Cantwell A, Bogache W, Richardson S, Tutrone RF, Barkin J, Fagelson J, Chin P, Woo H: Multicentre prospective crossover study of the “prostatic urethral lift” for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. BJU International 113; 615-622, March 2014

Yu E, Getzenberg R, Coss C, Gittelman M, Keane T, Tutrone R, Belkoff L, Given R, Bass J, Chu F, Gambla M, Gaylis F, Bailen J, Hancock M, Smith J, Dalton J, Steiner M: Selective Estrogen Receptor Alpha Agonist GTX-758 Decreases Testosterone with Reduced Side Effects of Androgen Deprivation Therapy in Men with Advanced Prostate Cancer. EUR UROL June 2014

Cookson M, Chang S, Lihou C, Li T, Harper S, Lang Z, Tutrone R: Use of intravesical valrubicin in clinical practice for treatment of nonmuscle-invasive bladder cancer, including carcinoma in situ of the bladder. Therapeutic Advances in Urology, 1 – 11, 2014

Ryan, Huo, Demers, Beer, Lacerna and The Zometa US05 Investigators: Ronald Tutrone, PI: Zoledronic Acid Initiated During the First Year of Androgen Deprivation Therapy Increases Bone Mineral Density in Patients With Prostate Cancer. Journal of Urology 176; 972-977, September 2006.

Price, Stein, Sieber, Tutrone RF, Bailen, Goluboff, Burzon, Bostwick and Steiner: Tormifene for the Prevention of Prostate Cancer Among Men with High-Grade Prostatic Intraepithelial Neoplasia: Results of a Double-Blind, Placebo-Controlled, Phase IIB Clinical Trial. Journal of Urology 176: 965-971, September 2006.

Valiquette, Young, Moncada, Porst, Vezina, Stancil, Edmunds, Montorsi and The Vardenafil Investigators: Ronald Tutrone, PI: Sustained Efficacy and Safety of Vardenafil for Treatment of Erectile Dysfunction: A Randomized, Double-Blind, Placebo-Controlled Study. Mayo Clinic Proceedings; 80 (10):1291-1297 October 2005 Gaylis FD, Ignatoff JM, Amling CL, Tutrone RF, Cosgrove DJ, Prostate Cancer in Men Using Testosterone Supplementation and Role of Physician Specialty in Diagnosis. Journal of Urology 174: 534-538, August 2005. Dunn JS, Bent AE, Tutrone RF, Elkermann RM: Acute Renal Failure caused by Complete Bladder Eversion through a Vesicovaginal Fistula. Accepted by International Urogynecology.

Staskin DR, Bavendam T, Miller J, Davilla GW, Diokno A, Knapp P, Rapport S, Sand P, Sant G, Tutrone RF: Effectiveness of a Urinary Control Insert in the Management of Stress Urinary Incontinence: Early Results of a Multicenter Study. UROLOGY 47:629-636,1996.

Van den Abbeele AD, Tutrone RF, Berman RM, Baranowska-Kortzylewicz J, Barclay PD, Richie JP, Adelstein SJ, Kassis AI: Tumor-Targeting Potential of Radioiodinated Dododeox Yuridine in Bladder Cancer: Evaluation in Tumor-Bearing Rats. J. Nuclear Medicine, 37:315-320,1996.

Sand P, Bavendam T, Davilla G, Diokno A, Karram M, Knapp P, Miller J, Rappaport S, Sant G, Staskin D, Tutrone RF: The Effect of a Urinary Control Insert on Quality of Life in Incontinent Females. Obstetrics and Gynecology, 1996. International Urogynecology Journal 1999;10:100-105.

Tutrone RF, Ball RA, Ornitz DM, Leder PA, Richie JR: Benign Prostatic Hyperplasia in a Transgenic Mouse: A New Hormonally Sensitive Investigatory Mode. J. Urol., 149:633-639, 1993.

Tutrone RF, Capelouto CC, Kavoussi LR: The Role of Laparoscopy in the Management of Prostate Cancer. In Wein AF, Malkowicz SB eds. Controversies in the Prostate Cancer. Part 11. Philadelphia: CoMed Communications; 1993.

Tutrone RF, Ball RA, Ornitz D, Leder PA, Richie JP: Benign Prostatic Hyperplasia in a Transgenic Mouse: A New Hormonally Sensitive Model. American College of Surgeons, Surgical Forum, XVII: 1991.

Van den Abbeele AD, Baranowska-Kortzylewicz J, Adelstein SJ, Carvalho PA, Tutrone RF, Richie JP, Wen PYC, Black PMcl, Mariani G, Kassis, AI: Diagnostic and Therapeutic Applications of Auger-Electron-Emitting 5-(123/125) Iodo-2’-Deoxyuridine in Cancer. Biophysical Aspects of Auger Processes, American Association of Physicists in Medicine. Symposium Series Number 8:372-295, 1992.

ABSTRACTS

Van Neste L, Groskopf J, Van Criekinge W, Jaljut M, Tutrone R, Sylora J, Anglade R, Murdock M, Moses K, Shiffman Z, Barnswell C, VandenBerg T, Shah N, Silberstein J, Waterouse R: Clinical Performanct of an Epigenetic Assay to Identify Occult High-Grade Prostate Cancer in African American Men. AUA, Boston, May 12-16, 2017

Shore N, Heath e, Whang Y, Nordquist L, Cheng H, Bhatt K, Huff S, Carroll N, Mangrolia D, Kraynyak K, Parikh R, Tagawa S, Lin J, Tutrone RF, Garcia J.A., Lee J, Yang Z, Bagarazzi M: A Clinical Trial for the Safety and Immunogenicity of a DNA-based Immunotherapy in Men with Biochemically (PSA) Relapsed Prostate Cancer. ASCO GU January 2017

Quinn DI, Freedland SJ, Heath EI, Tutrone RF, McLead DG, Sheikh NA, Chang NN, Sartor O: Survival Outcomes for African-American vs Matched Caucasian Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Sipuleucel-T ASCO GU January 2017 (Proceed)

Shore N, Tutrone RF, Mariados N, Nordquist L, Mehlhaff B, Harrelson S: Interim Results from eRADicAte: An Open-Label Phase 2 Study of Radium Ra 223 dichloride with Concurrent Administration of Abiraterone Acetate Plus Prednisone in Castration-Resistant Prostate Cancer Subjects with Symptomatic Bone Metatases. ASCO GU January 2016

Haas N, Stein M, Tutrone RF, Perini R, Denker A, Mauro D, Fong L: Phase 1-2 study of ADXS31-142 alone and in combination with pembrolizumab in patients with previously treated metastatic castration-resistant prostate cancer (mCRPC): The KEYNOTE-046 trial. ASCO GU January 2016

Cooperberg MR, Higano CS, Sartor AO, Pieczonka CM, Concepcion RS, Tutrone RF, Olsson CA, Bailen JL, Penson DF, Chang NN, Lill JS, Armstrong AJ: Treatment Patterns for Metastatic Castrate-Resistant Prostate Cancer in Urology and Oncology Practices: Data from the PROCEED Registry. ASCO GU January 2016

Rathkopf D, Smith M, Antonarakis E, Ryan C, Berry W, Shore N, Liu G, Higano C, Alumkal J, Hauke R, Tutrone RF, Saleh M, Maneval E, Thomas S, Ricci D, Yu M, de Boer C, Trinh A, Kheoh T, Bandekar R, Scher H: Androgen Receptor Mutations in Patients With Castration-Resistant Prostate Cancer With and Without Prior Abiraterone Acetate Treatment. AACR 2015: ARN-509-001 Mutation Analysis (Rathkopf)

Cooperberg M, Sartor O, Armstrong A, Pieczonka C, Concepcion R, Kassabian V, Tutrone RF, Bailen J, Shore N, Karsh L, Hertzman B, Penson D, McCoy C, Sandler A, Tyler R, Whitmore J, Higano C: Treatment Practice Patterns in Metastatic Castration-Resisitant Prostate Cancer (mCRPC) Patients (PTS) Prior To Receiving Sipuleucel-T (SIP-T): Data From PROCEED. AUA, San Diego, May 4 – 8, 2013

Shore N, Tutrone RF: Transrectal Injection of NX-1207 for the Treatment of Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH). EAU, Milan, January 2013

Nabhan C, Sartor O, Cooperberg M, Vacirca J, Concepcion R, Berry W, Dhawan M, Tutrone RF, Sandler A, McCoy C, Whitmore J, Tyler R, Higano C: Real-world experience with sipuleucel-T in metastatic castration- resistant prostate-cancer (mCRPC) patients (pts) >80 years-old: Data from PROCEED. ASCO GU January 2013

Tutrone RF, Bent A, McLennan M, Goldstein DS: Treatment of ISD Urinary Incontinence in Women Using Autologous Chondrocytes-Preliminary Results. Hilton Head, SC, October 3-6, 1999.

McAleer H, Tutrone RF: Biofeedback/Electrical Stimulation Therapy in the Management of Urinary Incontinence in a Clinical Urology Practice. Annual Meeting AUA, Las Vegas, NV. April 23-28, 1995. Duckett M, Goldstein DS, Goldstein RB, Shackleford N, Baker LS, Tutrone RF: The Use of Oral Trazodone for the Treatment of Venogenic Erectile Dysfunction. Annual Meeting AUA, Las Vegas, NV. April 23-28, 1995.

Capelouto CC, Raymond SA, Case CR, Tutrone RF, Richie JP, Vickers MA: Intraoperative Tumescence Monitoring During Radical Prostatectomy. Annual Meeting AUA, San Antonio, TX. May 15-20, 1993.

Tutrone RF, O’Donnell MA, Goldstein DS, Brodsky G, DeWolf WC, Richie JP: Intravesical Therapy with BCG for Transitional Cell Carcinoma of the Bladder in a Rat Model. Annual Meeting AUA, San Antonio, TX. May 15-20, 1993

Tutrone RF, Goldstein DS, O’Donnell MA, Brodsky G, DeWolf WC, Richie JP: Intravesical Therapy with BCG for Transitional Cell Carcinoma of the Bladder in a Rat Model. Joint Annual Meeting Northeastern/New England Section AUA, Toronto, Ontario, Canada. September 13-16, 1992.

Tutrone RF, Ball RA, Ornitz D, Leder PA, Richie JP: Benign Prostatic Hyperplasia in a Transgenic Mouse: A New Hormonally Sensitive Investigatory Model. Annual Meeting AUA, Washington, D.C. May 10-14, 1992. Van den Abbeele AD, Tutrone RF, Berman RM, Baranowska-Kortylewicz J, Barclay PD, Richie JP, Adelstein SJ, Kassis AI: 5-(123I/125I) Iodo-2’-Deoxyuridine (*IUdR) as Diagnostic and Potential Therapeutic Agents for Bladder Cancer. Annual Radiation Research Society. Salt Lake City, UT. March 14-18, 1992.

Van den Abbeele AD, Barclay PD, Tutrone RF, Goldstein DS, Makrigiorgos GM, Berman RM, Weinberg DS, Richie JP, Adelstein SJ, Kassis, AI.: Radioiodinated IUdR (*IUdR) Uptake in Exfoliated Cells Obtained from Patient with Bladder Cancer: Implications for Diagnosis and Therapy. Annual Radiation Research Society, Salt Lake City, UT. March 14-18, 1992.

Tutrone RF, Ball RA, Ornitz D, Leder PA, Richie JP: Benign Prostatic Hyperplasia in a Transgenic Mouse: A New Hormonally Sensitive Mode. Annual Meeting New England Section AUA, Dixville Notch, NH. October 6-9, 1991.

Tutrone RF, Bauer SB, Peters CA, Mandell, J, Colodny AH, Retik AB: Physiologic Basis for Continence in the Mitrofanoff Principle. Annual Meeting AUA, Toronto, Canada. June 2-6, 1991.

Richie JP, Ball RA, Tutrone RF, Ornitz D, Leder PA: Int-2 Transgenic Mouse: New Investigatory Model for BPH. American Association of Genitourinary Surgeons, Annual Meeting, Naples, FL. April 4-6, 1991.

Tutrone RF, Bauer SB, Mandell J, Colodny AH, Retik AB: The Use of the Mitrofanoff Principle for Continent Urinary Diversion. Annual Meeting New England Section AUA, Edinburg, Scotland. October 21-27, 1990. Tutrone RF, Laungani G: A New Method for Treatment of Intra-urethral Hair Growth Following Urethroplasty. Annual Valentine Resident Essay Meeting, New York Academy of Medicine. March 30, 1988.

VIDEOS

Tutrone RF, Bailey RW: Laparoscopic Ureterolysis for Ovarian Vein Syndrome. Annual Meeting AUA, Las Vegas, Nevada. April 23-28, 1995.

Capelouto CC, Tutrone RF, Kavoussi LR: Laparoscopic Tissue Dissection Utilizing the Cavitational Ultrasonic Surgical Aspirator. Eleventh World Congress on Endourology, Florence, Italy. October 20-23, 1993.

Rosenberg M, Tutrone RF, Kavoussi L, Clayman R: Laparoscopic Radical Nephrectomy. Eleventh World Congress on Endourology, Florence, Italy. October 20-23, 1993.

Rosenberg MT, Tutrone RF, MacLeod SA, Clayman RV, Kavoussi LR: Laparoscopic Radical Nephrectomy. Video Urology ’93 5th World Congress, Orlando, Florida. June 24-27, 1993.

Rosenberg MT, Tutrone RF, MacLeod SA, Clayman RV, Kavoussi LR: Laparoscopic Radical Nephrectomy. Annual Meeting AUA, San Antonio, TX. May 15-20, 1993.

Capelouto CC, O’Donnell MA, Tutrone RF, Kavoussi LR: Laparoscopic Tissue Dissection Utilizing the Cavitron Ultrasonic Surgical Aspirator. Annual Meeting AUA, San Antonio, TX. May 15-20, 1993.

Tutrone RF, Silverman SC, Kikinis R, Chernoff DM, Loughlin KR, Richie JP: Partial Nephrectomy with 3-D Image Enhancement. Countway Urology Grand Rounds, Harvard Medical School, Boston MA, October 3, 1992 Ho, GT, Tutrone RF, Colodny A, Kavoussi LR: Endoscopic Hydrocele Ablation. Videourology ’92, 4th World Congress, Monte-Carlo. October 1-3, 1992.

CLINICAL RESEARCH (108 STUDIES TOTAL)

1) Advaxis Inc 2/2015-Present Principal Investigator A Phase 1-2 Dose-Escalation and Safety Study of ADXS31-142 Alone and of ADXS31-142 in Combination with Pembrolizumab (MK-3475) in Patients with Previously Treated Metastatic Castration-Resistant Prostate Cancer

2) ALZA Corporation 1993-1995 Co-Investigator Acceptability of Testerderm testosterone, transdermal systems in private clinical practice.

3) American Medical System/Pfizer 1996-2003 Principal Investigator A multicenter prospective cohort study to evaluate the safety and effectiveness of the American Medical Systems’ Ambicor inflatable penile prosthesis.

4) Amgen 03/2007- 09/2012 Principal Investigator A Randomized, Double-Blind, Placebo-Controlled, Mutli-Center Phase 3 Study of Denosumab on Prolonging Bone Metastasis-Free Survival in Men with Hormone-Refractory Prostate Cancer.

5) Aragon 06/2012-Present Principal Investigator Open-Label, Phase ½ Safety, Pharmacokinetic, and Proof-of-Concept Study of ARN-509-001 in Patients with Progressive Advanced Castration-Resistant Prostate Cancer

6) Aragon 01/2014-Present Principal Investigator A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509-003 in Men with Non-Metastatic (M0) Castration-Resistant Prostate Cancer SPARTAN

7) Astellas Pharma Global 11/2016-Present Principal Investigator A Phase 2 Open-label Extension Study for Subjects with Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study 9785-CL-0123

8) Astellas Pharma Global 7/2016-Present Sub-Investigator Astellas ENACT A Randomized Study of Enzalutamide in Patients with Localized Prostate Cancer Undergoing Active Surveillance 9785-MA-1010

9) Astellas Scientific and Medical Affairs 5/2015-Present Sub-Investigator TRUMPET Registry: A Prospective Observational Cohort Study of Patients with Castration-resistant Prostate Cancer (CRPC) in the United States ONC-MA-1004

10) AstraZeneca 2/2017-Present Principal Investigator A Phase III, Open Label, Randomized Study to Assess the Efficacy and Safety of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men with Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment with a New Hormonal Agent and Have Homologous Recombination Repair Gene Mutations (PROfound) D081DC00007

11) Auxillium 12/2014-Present Principal Investigator Long Term Follow Up (AUX-CC-810): Long-Term Safety, Curvature Deformity Characterization, And Immunogenicity Over Time in Subjects Previously Treated with AA4500 for Peyronie's Disease in Studies AUX-CC-802, AUX-CC-803, AUX-CC-804, and AUX-CC-806

12) Auxilium Pharmaceuticals, Inc. 11/2010-06/2012 Principal Investigator A Phase 3, Double Blind, Randomized, Placebo-Controlled Study of the Safety and Effectiveness of AA4500 Administered Twice per Treatment Cycle for up to Four Treatments Cycles (2x4) in Men with Peyronie’s Disease (Aux-CC-803)

13) Auxilium Pharmaceuticals, Inc. 08/2012- 03/2014 Principal Investigator Phase 3, Open-Label Study of the Safety and Effectiveness of AA4500 administered twice per treatment cycle for up to four treatment cycles (2x4) in men with Peyronie’s Disease

14) Bayer HealthCare 11/2016-Present Principal Investigator Bayer ARASENS: A randomized, double-blind, placebo-controlled Phase III study of ODM-201 versus placebo in addition to standard androgen deprivation therapy and docetaxel in patients with metastic castration sensitive prostate cancer BAY 1841788 / 17777

15) Bayer HealthCare 12/2016-Present Principal Investigator Management, Treatment Patterns and Outcomes of Metastatic Castrate Resistant Prostate Cancer Patients Treated with Radium-223 BAY 1841788 / 18919

16) Bayer HealthCare 1/2017-Present Principal Investigator Bayer Aramis: A Multinational, Randomised, Double-Blind, Placebo-Controlled, Phase III Efficacy and Safety Study of ODM-201 in Men with High-Risk Non-Metastatic Castration-Resistant Prostate Cancer BAY 1841788 / 17712

17) Bayer HealthCare 8/2015-Present Principal Investigator ERA 223 Bayer 15396: A phase III randomized, double-blind, placebo-controlled trial of radium-223 dichloride in combination with abiraterone acetate and prednisolone in the treatment of asymptomatic or mildly symptomatic chemotherapy-naïve subjects with bone predominant metastatic castration-resistant prostate cancer (CRPC)

18) Bayer HealthCare 11/2015-Present Sub-Investigator REASSURE: Radium-223 alpha Emitter Agent in Safety Study in mCRPC Population for Long-Term Evaluation

19) Bayer, Inc. 01/2000-08/2000 Principal Investigator A randomized, open-label, comparative, experience trial of ciprofloxacin hydrochloride (250 to 500mg bid for 3-14 days) versus trimethoprim/sulfamethoxazole (160/800mg bid for 10-14 days) in the treatment of outpatient adults with lower urinary tract infections. Protocol 100231.

20) Beckman Coulter, Inc 5/2015-Present Principal Investigator PHI-Beckman: A Prospective, Observational Study of the Clinical Decision Impact of the Prostate Health Index Test in a Urology Practice Setting

21) Bioniche Life Sciences, Inc. 05/2008- 03/2012 Principal Investigator Open-Label, Multi-Center Study of the Efficacy and Safety of MCC in the treatment of Patients with Non-Muscle Invasive (Superficial) Bladder Cancer at High Risk of Progression and who are Refractory to BCG.

22) Boehringer Ingelheim 04/2001-02/2002 Principal Investigator A Phase II, double-blind, randomized, parallel-group design, multicenter study of FLOMAX® capsules, 0.4mg daily versus placebo in male patients with acute urinary retention related to benign prostatic hyperplasia.

23) Boston Scientific 05/2007-09/2014 Principal Investigator Post Marketing Study using Prolieve ™for the treatment of Benign Prostatic Hyperplasia (BPH).

24) BioServe Biotechnologies, Ltd. 01/2011-12/2014 Principal Investigator Multi-Site, Collection of Anonymized Biological Specimens and Phenotypic Data from a Large Cohort of Subjects for Inclusion in a Repository ad Use in Genomic (from DNA and RNA), Serologic and Metabolic (from Serum) and Proteomic (from Protein) research studies (Pro00005300)

25) Carolina Research Professionals 8/2015- Present Principal Investigator EnzaRadicate: Open label phase two study of Enzalutamide with concurrent administration of Radium Ra 223 dichloride in Castration-Resistant (Hormone-Refractory) Prostate Cancer subjects with symptomatic bone metastases in both the pre- and post-chemotherapy setting

26) Celsee Diagnostics 8/2016-Present Principal Investigator PREP400: Prostate Cancer Assay performance of Celsee Diagnostics circulating tumor cell (CTC) analysis system will be validated in patients diagnosed with metastatic prostate cancer. It will demonstrate performance equivalency to predicate device, CellSearch CTC Assay (Veridex, Raritan, NJ).

27) Curon Corp, LLC 07/2001-05/2002 Principal Investigator Two-arm randomized, double-blind pilot herbal study for treatment of ureteral calculi.

28) Dendreon Corporation 07/2012-Present Principal Investigator A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer

29) Dendreon Corporation 02/2013-Present Principal Investigator Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T

30) Dendreon Corporation 03/2014-Present Principal Investigator A Study to Evaluate Characteristics Predictive of a Positive Imaging Study for Distant Metastases in Patients with Castration-Resistant Prostate Cancer.

31) Dendreon Corporation 06/2004-09/2006 Principal Investigator A Randomized, Double-Blind, Placebo Controlled Phase 3 Trial of Immunotherapy with Autologous Antigen Presenting Cells Loaded with PA2024 (Provenge ®, APC8015) in Asymptomatic Subjects with Gleason Sum ≤ 7 Metastatic, Androgen Independent Prostatic Adenocarcinomas

32) Duke 8/2014-Present Principal Investigator Caps 2 (Duke): A Randomized Controlled Clinical Trial of Carbohydrate Restriction Among Men with a Rising PSA after Failed Primary Therapy for Prostate Cancer

33) Duke PSA 3/2016-Present Sub-Investigator DUKE PSA: Retrospective Review Evaluating the PSA Changes in Patients with Metastatic Castrate Resistant Prostate Cancer after Sipuleucel-T treatment

34) Eli Lilly 2000-08/2006 Principal Investigator Open Label. Long-term monitoring of safety in subjects treated with duloxetine for stress urinary incontinence.

35) Eli Lilly 09/2000-02/2002 Principal Investigator A Phase III efficacy and safety of duloxetine compared with placebo in subjects with stress urinary incontinence.

36) Eli Lilly and Company 1998-1999 Principal Investigator Duloxetine versus placebo in the relief of stress urinary incontinence (Phase III)

37) Endo Pharmaceuticals, Inc. 03/2011-03/2013 Principal Investigator A Phase 3, Randomized, Active-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of EN3348 (MCC) as Compared with Mitomycin C in the Intravesical Treatment of Subjects with BCG Recurrent or Refractory or Refractory Non-Muscle Invasive Bladder Cancer

38) Exelis, Inc 11/2012-10/2014 Principal Investigator A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs. Prednisone in Metastatic Castrationresistant Prostate Cancer Patients who have Received Prior Docetaxel and Prior Abiraterone or MDV310

39) Ferring Pharmaceuticals, Inc. 10/2009-11/2012 Principal Investigator A Randomized, Controlled, Open-Label Trial of Degarelix Intermittent Therapy vs. Continuous Androgen Deprivation Therapy with Leuprolide or Degarelix in Patients with Carcinoma of the Prostate with Biochemical Failure after Localized Therapy

40) Focus Surgery, Inc. 09/2010- 2012 Principal Investigator A Multicenter Clinical Study of the Sonablate® (Sonablate for the Treatment of locally Recurrent Prostate Cancer with HIFU (STAR Trial)

41) Genentech, F. Hoffmann-LaRoche Ltd 12/2015-Present Principal Investigator Genentech: A Phase III, Open-Label, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Versus Observation as Adjuvant Therapy in Patient with PD-L1-Selected, High-Risk Muscle-Invasive Bladder Cancer after Cystectomy WO29636

42) Genomic Health 12/2014-Present Principal Investigator GH 09-023: A Prospective Multicenter Observational Trial to Assess Persistence on Active Surveillance When Using the Oncotype DX Prostate Cancer Assay

43) Genomic Health 12/2014-Present Principal Investigator GH 14-001: Genomic Markers in Transitional Cell Cancer of the Bladder, Renal Pelvis and Ureter: Sample Acquisition for Methods Development and Discovery

44) Genomic Health 11/2015-Present Principal Investigator Validation Study GH 14-006: Clinical Validation of a Urine-Based Assay With Genomic and Epigenomic Markers for Predicting Recurrence during Surveillance for Non-Muscle Invasive Bladder Cancer

45) GlaxoSmithKline, Inc. 06/2003-09/2010 Principal Investigator 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.

46) GlaxoSmithKline, Inc. 06/2003-01/2005 Principal Investigator A randomized, double-blind, parallel-group, placebo-controlled study evaluating the efficacy, safety and reliability of 10mg vardenafil administered for 12 weeks compared to placebo in subjects with erectile dysfunction and a demonstrated successful first response to 10mg vardenafil.

47) Gtx, Inc. 07/2012- 3/2016 Principal Investigator Phase II A Open-Label study of the effect of GTx-758 as secondary hormonal therapy on serum PSA and serum free testosterone levels in men with metastatic castration resistant prostate cancer maintained on androgen deprivation therapy

48) Gtx, Inc. 01/2005- 07/2009 Principal Investigator Phase III, A Randomized, Double-Blind, Placebo-Controlled, Multicenter Efficacy and Safety Study of Toremifene Citrate for the Prevention of Prostate Cancer in Men with High Grade Prostatic Intraepithelial Neoplasia (PIN).

49) GTx, Inc. 05/2002-05/2003 Principal Investigator A Phase II, 4 arm, dose-finding, randomized, placebo-controlled study to determine the safety & efficacy of 20mg, 40mg & 60mg toremifene in prevention of osteoporosis of androgen deprivation.

50) Health Decisions, Inc. 2001- 07/2003 Principal Investigator A multicenter, pivotal Phase III, two-arm randomized placebo-controlled study to determine the chemoprevention efficacy and safety of 60mg daily of GTX-006 against high-grade prostate intraepithelial neoplasia (PIN).

51) Hoffman-La Roche, Inc. 12/2002-01/2005 Principal Investigator NN16378 open-label extension for treatment of incontinent patients who have completed an Ro115-1240 study.

52) Hoffman-La Roche, Inc. 05/2002-11/2004 Principal Investigator Randomized, double-blind, placebo-controlled, dose finding study to evaluate the effects of a partial alpha adrenoceptor agonist, Ro115-1240, in women with stress urinary incontinence or mixed urinary incontinence.

53) ICOS Corporation 06/2003-09/2005 Sub-Investigator A Phase II, randomized, double-blind, placebo-controlled study of the safety and efficacy of RTX topical solution in patients with interstitial cystitis.

54) Inovio Pharmaceuticals Inc. 1/2016-Present Principal Investigator Phase I, Open-Label Trial to Evaluate the Safety and Immunogenicity of INO-5150 Alone or in Combination with INO-9012 in Men with Biochemically Relapsed (PSA) Prostate Cancer Pca-001

55) Janssen Research & Development, LLC 3/2015-Present Principal Investigator ACIS (PCR3001): A Phase 3 Randomized, Placebo-controlled Double-blind study of JNJ-56021927 in Combination with Abiraterone Acetate and Prednisone in Subjects with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC)

56) Janssen Research & Development, LLC 10/2015-Present Principal Investigator TITAN (PCR3002): A Phase 3 Randomized, Placebo-controlled, Double-blind Study of JNJ-56021927 Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects with Low-volume Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

57) Janssen Research & Development, LLC 09/2012-Present Principal Investigator IMAAGEN PCR2005 Multi-Center, Open-Label, Single-arm, Phase 2 Study of Abiraterone Acetate Plus Prednisone in Subjects with Advanced Prostate Cancer Without Radiographic Evidence Of Metastatic Disease

58) Kyowa Pharmaceutical, Inc. 05/2002-12/2002 Principal Investigator A 6-week, double-blind, placebo-controlled randomized, parallel-group, multicenter, multi-dose study of the efficacy and safety of KW-7158 in patients with overactive bladder symptoms of increased urinary frequency, urgency and urge incontinence.

59) MDxHealth 9/2014-5/2016 Sub-Investigator Pascual Trial: A randomized, controlled, prospective study to track the clinical utility of an epigenetic assay, ConfirmMDx for Prostate Cancer, in U.S. urologic practices for histologically cancer-negative patient management

60) MDxHealth 7/2015-5/2016 Principal Investigator Confirm MDx: Perspective study to evaluate the clinical utility of confirm MDx for prostate cancer assay for men with previous histiologaclly-negative prostate biopsies

61) MDxHealth 12/2015-Present Principal Investigator Clinical Utility of ConfirmMDx for Prostate Cancer Assay Negative Results on the Decision for Repeat Biopsy

62) Medivation 9/2015-Present Principal Investigator EMBARK: A Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide Plus Leuprolide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide in Men with High-Risk Nonmetastatic Prostate Cancer Progressing After Definitive Therapy MDV3100-13

63) Medivation, Inc 07/2012-Present Principal Investigator STRIVE: A Multicenter Phase 2, Randomized, Double-Blind, Efficacy and Safety Study of Enzalutamide vs. Bicalutamide in Men with Prostate Cancer who have failed Primary Androgen Deprivation Therapy MDV3100-09

64) Medivation, Inc 02/2015-Present Principal Investigator STRIVE OLE: A Multicenter Phase 2, Randomized, Double-Blind, Efficacy and Safety Study of Enzalutamide vs. Bicalutamide in Men with Prostate Cancer Who Have Failed Primary Androgen Deprivation Therapy MDV3100-09

65) Medivation, Inc 3/2017-Present Principal Investigator STRIVE MOLE: A Phase 2 Open-label Extension Study for Subjects with Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

66) Medtronics, Inc. 2001-2004 Principal Investigator Medtronics Interstim® Patient Registry

67) Medtronics, Inc. 1996-1998 Principal Investigator Randomized multicenter evaluation of the safety and effectiveness of the sacral nerve stimulation system for the treatment of urinary dysfunctional voiding patterns.

68) Merck 07/2006-2007 Principal Investigator A multi-center, double-blind, randomized, placebo-controlled, parallel-group, dose-ranging study of L-000796568 in postmenopausal women with overactive bladder.

69) Merck, Inc. 06/2003-07/2005 Principal Investigator A double-blind, randomized, placebo-controlled, multicenter study to evaluate the effects of rofecoxib in decreasing the risk of prostate cancer (VIP study).

70) Mundipharma 11/2014-3/2016 Principal Investigator CROM: A phase 2 randomized, double-blind, placebo controlled study of MR901 in patients with moderate to severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH)

71) NeoTract 2/2016-Present Principal Investigator MedLift Study: Study Median Lobe Prostatic UroLift Procedure

72) NeoTract 2/2011-Present Sub-Investigator LIFT Study: Luminal Improvement Following Prostatic Tissue Approximation for the Treatment of Lower Urinary Tract Symptoms

73) NeoTract 2/2011-Present Principal Investigator LOCAL Study: UroLift System Tolerability and Recovery When Administering Local Anesthesia

74) Novartis Pharmaceuticals 06/2003-10/2005 Principal Investigator A double-blind, placebo-controlled study of the effect of zolendronic acid on bone mineral density in men receiving androgen-deprivation therapy for prostate cancer.

75) NxThera 12/2013-Present Sub-Investigator Rezum II: Minimally Invasive Prostatic Vapor Ablation - Multicenter, Randomized, Controlled Study for the Treatment of BPH

76) Nymox Pharmaceuticals, Inc. 10/2009-11/2016 Principal Investigator Phase 3, Multicenter, Prospective, Randomized, Parallel-Group Placebo-Controlled Double-Blind Clinical Evaluation of NX-1207 for the Treatment of BPH 02-0018

77) Nymox Pharmaceuticals, Inc. 06/2012-Present Principal Investigator Phase 2, Multi-center Prospective Open Label 2-Dose Level Clinical Safety and Efficacy Evaluation of Injection of NX-1207 for the Treatment of Low Risk, Localized (T1c) Prostate Cancer 03-0040

78) Nymox Pharmaceuticals, Inc. 06/2012-12/2016 Principal Investigator Phase 3 Multicenter Prospective Open Label Clinical Safety Evaluation of Re-Injection of NX- 1207 for the Treatment of BPH: Doses 1-7 years Apart 02-0020

79) Nymox Pharmaceuticals, Inc. 12/2012-12/2016 Principal Investigator Phase 3 Multi-center Prospective Open Label Clinical Safety Evaluation of Re-Injection of NX-1207 for the Treatment of BPH: Two Doses 1-8 Years Apart 02-0022

80) Pfizer, Inc. 06/2003-01/2005 Principal Investigator A multicenter, randomized, parallel-group, double-blind, placebo-controlled, flexible dose escalation study to evaluate sexual and relationship satisfaction in the female partner of men with erectile dysfunction treated with Viagra® (sildenafil citrate) in the US.

81) Pharmacia 05/2002-12/2002 Principal Investigator A double-blind, placebo-controlled, randomized US study to evaluate the effect of tolterodine prolonged release on nocturia in patients with symptoms of overactive bladder (OAB).

82) Pharmacia & Upjohn 01/2000–10/2001 Principal Investigator A patient acceptability study of a once-daily formulation of tolterodine. A Phase IIIB open-label, single-arm trial in adult patients with overactive bladder and symptoms of urinary frequency/urgency and/or urge incontinence.

83) Pharmacia & Upjohn 1999-2003 Principal Investigator A national Phase II trial of Interferon Alfa 2B (Intron A) plus BCG for treatment of superficial bladder cancer

84) Pharmacia & Upjohn 1998-1999 Principal Investigator A multicenter, pivotal Phase III two-arm, long-term safety and efficacy of tolteradine prolonged release capsules.

85) Pharmacia & Upjohn 1998-1999 Principal Investigator Dose escalation study with tolterodine in patients with overactive bladder. A single-blind study in patients with symptoms of overactive bladder including urinary urgency and frequency with or without urge incontinence.

86) Reprogenesis/Curtis 2000/2002 Principal Investigator A Phase II randomized, double-blind study comparing chondrogel (autologous chondrogel in alginate hydrogel) & alginate hydrogel for treatment in women with stress urinary incontinence due to ISD.

87) Reprogenesis 1999-2001 Principal Investigator Protocol for the re-treatment with chondrogel (chondrocyte-alginate gel suspension) of patients enrolled in Reprogenesis’ protocol 96-03.

88) Reprogenesis, Inc. 1996-1999 Principal Investigator Protocol for the clinical investigation of an autologous tissue implant for the treatment of urinary incontinence.

89) R.W. Johnson Pharmaceuticals 1994-1995 Co-Investigator Multicenter, double-blind, randomized study to compare the safety and efficacy of oral levofloxacin with that of ciprofloxacin HCL in the treatment of complicated urinary tract infections in adults.

90) Sanofi-Aventis, Inc. Investigator Initiated Trial 04/2009-08/2012 Principal Investigator A Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of Alfuzosin in Treating Men with ED and Mild LUTS.

91) Sanofi-Aventis, Inc. 01/2007-12/2010 Principal Investigator A Randomized, Open Label, Multicenter, Phase III, 2-Arm Study of Androgen Withdrawl with Leuprolide +/- Docetaxel for Clinically Asymptomatic Prostate Cancer Subjects with a Rising PSA Following Definitive Local Therapy.

92) Sanofi- Synthelabo, Inc. 10/2003-09/2009 Investigator Initiated Protocol An Open Label Study of Serum Testosterone Recovery and PSA after Six Months of Neo-Adjuvant Treatment with EligardTM 22.5mg with Radiation Therapy in Patients with Early Stage Prostate Cancer.

93) Schwarz Biosciences 07/2002-2004 Principal Investigator A Phase II, parallel group, stratified, randomized, double-blind, placebo-controlled trial to investigate efficacy and safety of multi-dosages of fesoteridine in subjects with overactive bladder showing either involuntary detrusor contractions or normal findings during the baseline urodynamic assessment.

94) Schwarz Biosciences 08/2003-12/2004 Principal Investigator Two phase extension trial of SP668 to investigate the safety and tolerability of sustained release fesoterodine in subjects with overactive bladder: A double-blind phase followed by an open-label phase extension phase.

95) Serenity Pharmaceuticals 06/2012- 04/2014 Principal Investigator Randomized, Double Blind, PlaceboControlled, Parallel Group, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulations In Patients with Nocturia

96) SmithKline Beecham Pharmaceuticals 1993-1995 Co-Investigator A one-year, multicenter, double-blind comparison of the effects of once-daily dosing with three dose levels of SK&F 105657 or placebo in the treatment of symptomatic BHP, with six-month untreated follow-up

97) Solvay 03/2007- 2008 Principal Investigator A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Testosterone Gel 1.62% for the Treatment of Hypogonadal Men.

98) Sophiris Bio Corp 01/2013 – 10/2015 Principal Investigator A Randomized, Double-Blind, Vehicle-Controlled, Dose Confirmation, Multicenter Safety and Efficacy Study of a Single Intraprostatic Treatment of PRX302 for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia (The PLUS 1 Trial)

99) Spectrum Pharmaceuticals, Inc. 04/2009- 08/2012 Principal Investigator A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Phase 3 Trial of Single-Dose Intravesical EOquin® as a Surgical Adjuvant Instilled in the Early Postoperative Period in Patients Undergoing Transurethral Resection for Noninvasive Bladder Cancer

100) TAP Holdings, Inc. / Quintiles 01/2000-11/2001 Principal Investigator A Phase II, 12-week safety and efficacy study of oral TAK-637 versus placebo in subjects with overactive bladder.

101) TAP Holdings, Inc. 1998-2000 Principal Investigator A Phase III long-term, open label, flexible dose, safety extension study of apomorphine SL tablets in a special population for the treatment of male erectile dysfunction.

102) TAP Holdings, Inc. 1998-1999 Principal Investigator A Phase III safety and efficacy study of two fixed doses of apomorphine SL tablets versus placebo in the treatment of male erectile dysfunction in patients with controlled diabetes.

103) TAP Pharmaceutical Inc. 2000-11/2001 Principal Investigator A Phase II, 52-week extension study to evaluate long-term safety of oral TAK-637in subjects with overactive bladder.

104) University of California, San Francisco 6/2013-Present Principal Investigator CAPSURE: Cancer of the Prostate Strategic Urologic Research Endeavor

105) Upjohn Company 1994-1996 Principal Investigator Phase III study of oral bropiramine versus intravesical BCG in adult patients with BCG-naïve bladder carcinoma in-situ.

106) Uromed Corporation 1993-1998 Principal Investigator Clinical investigation of a urethral occlusion device for the treatment of stress urinary incontinence.

107) Warner Chilcott 07/2013-05/2014 Principal Investigator A Study to Assess the Safety and Efficacy of Udenafil in Men with Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (BPH), Study PR-05710

108) Yamanouchi Pharma America 06/2004- 11/2005 Principal Investigator Phase 3B, An Open Label Multicenter Study to Assess The Efficacy and Safety of Daily Oral Administration of 5 and 10 mg Vesicare (Solifenancin Succinate) in Patients Who Wish to Switch from Detrol LA® (Tolterdine Tartrate Extended Release) For The Treatment of Overactive Bladder Symptoms /YPA905-UC-006.