Description of Research Study: To improve quality of care by educating patients prior to treatment on the outcomes they can expect post treatment, the Department of Urologic Surgery is inviting patients planning definitive management of prostate cancer with radiation therapy or surgical prostatectomy to participate in this study which will evaluate the benefit of expanded pre-treatment counseling and education.
Principal Investigator: Marc Dall'Era, M.D., Department of Urologic Surgery
Co-Investigator: Christopher P. Evans, M.D., F.A.C.S., Department of Urologic Surgery
Research Coordinator: Randev Sandhu, CCRP, Department of Urologic Surgery

A Randomized Study of Enzalutamide in Patients with Localized Prostate Cancer Undergoing Active Surveillance (ENACT)

Description of Research Study: The purpose of this research study is to find out how effective and safe Enzalutamide is to delay the progression of early stage prostate cancer. This will be compared with Active Surveillance (AS), also known as “watchful waiting,” where men are treated only if they develop symptoms from their cancer.
Principal Investigator: Christopher P. Evans, M.D., F.A.C.S., Department of Urologic Surgery
Co-Investigator: Marc Dall'Era, M.D., Department of Urologic Surgery
Research Coordinator: Randev Sandhu CCRP, Department of Urologic Surgery

A Selective Frontline Cabazitaxel Therapeutic Pathway for Castration-Resistant Prostate Cancer with Integrated Biomarkers

Description of Research Study: This phase II trial studies how well cabazitaxel and prednisone work in treating patients with hormone-resistant prostate cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as cabazitaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Principal Investigator: Christopher P. Evans, M.D., F.A.C.S., Department of Urologic Surgery
Co-Investigator: Primo Lara, M.D., Department of of Internal Medicine, Division of Hematology Oncology
Research Coordinator: Daniel Robles, UC Davis Comprehensive Cancer Center

MDV3100-03: PREVAIL: A Multinational Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oral MDV3100 in Chemotherapy-Naïve Patients with Progressive Metastatic Prostate Cancer Who Have Failed Androgen Deprivation Therapy

Description of Research Study: This study is to learn more about side effects that occur with enzalutamide treatment and to further evaluate life expectancy while taking enzalutamide
Principal Investigator: Christopher P. Evans, M.D., F.A.C.S., Department of Urologic Surgery
Co-Investigator: Primo Lara, M.D., Department of Internal Medicine, Division of Hematology Oncology
Research Coordinator: Daniel Robles, UC Davis Comprehensive Cancer Center

Enzalutamide and Metformin Combination Therapy To Overcome Autophagy Resistance In Castration Resistant Prostate Cancer (CRPC)

Description of Research Study: The purpose of this study is to find out how well the drug enzalutamide works in combination with metformin against your CRPC. We also want to find out which is the best dose of metformin in combination with enzalutamide for treating CRPC. Additionally, we want to find out more information about the side effects of combining enzalutamide and metformin since this is an investigational combination.
Principal Investigator: Christopher P. Evans, M.D., F.A.C.S., Department of Urologic Surgery
Co-Investigator: Primo Lara, M.D., Department of of Internal Medicine, Division of Hematology Oncology
Research Coordinator: Daniel Robles, UC Davis Comprehensive Cancer Center

EMBARK, MCV3100-13, 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

Description of Research Study: This study is also being done to test the safety of enzalutamide by itself and together with leuprolide, meaning how taking these drugs may affect your health (includes looking for possible side effects). The effects on your quality of life will also be tested.
Principal Investigator: Christopher P. Evans, M.D., F.A.C.S., Department of Urologic Surgery
Co-Investigator: Primo Lara, M.D., Department of Internal Medicine, Division of Hematology Oncology
Research Coordinator: Daniel Robles, UC Davis Comprehensive Cancer Center

Description of Research Study: In hopes to improve men's health we are conducting a survey research project on men with nodules and/or cords in the hand, a condition called Dupuytren's disease, and to better understand the prevalence of Peyronie's disease. Our goal is to increase awareness of this comorbidity in hopes that it may facilitate prompt referral for treatment and improve patient quality of life.
Principal Investigator:  Jennifer Rothschild, M.D., M.A., M.P.H., Department of Urologic Surgery
Co-Investigator: Robert Szabo, M.D., Department of Orthopaedics
Research Coordinator: Randev Sandhu, CCRP, Department of Urologic Surgery

Pictoral Scale of Bladder Urgency

Description of Research Study: We are studying a way to help children tell their doctors how they feel when they have to go to the bathroom.
Principal Investigator: Eric Kurzrock, M.D., F.A.A.P., Department of Urologic Surgery
Co-Investigator: Paula Wagner, F-N.P., Department of Urologic Surgery
Research Coordinator: Randev Sandhu, CCRP, Department of Urologic Surgery

Pictoral Scale of Bladder Fullness and Bladder Volume During Voiding Cystgraphy

Description of Research Study: We are studying a way to help children tell their doctors how they feel when they have to go to the bathroom.
Principal Investigator: Eric Kurzrock, M.D., F.A.A.P., Department of Urologic Surgery
Co-Investigator: Paula Wagner, F-N.P., Department of Urologic Surgery
Research Coordinator: Randev Sandhu, CCRP, Department of Urologic Surgery

CONTENT1- A phase III, multicentre, randomised, double blind, parallel group, placebo controlled study to assess the efficacy and safety of one or more intradetrusor treatments of 600 or 800 units of Dysport® for the treatment of urinary incontinence in subjects with neurogenic detrusor overactivity

Description of Research Study: The main objective of this study is to evaluate if Dysport® is effective and safe for the treatment of urinary incontinence due to NDO. With NDO the bladder muscle does not relax and contracts too often, this leads to frequent urinary incontinence (leakage of urine).
Principal Investigator: Jennifer Rothschild M.D., M.A., M.P.H., Department of Urologic Surgery
Co-Investigator: Marc Dall’Era, M.D., Department of Urologic Surgery
Research Coordinator: Randev Sandhu CCRP, Department of Urologic Surgery

A Phase 3, Multicenter Trial Evaluating the Efficacy and Safety of MitoGel™ on Ablation of Upper Urinary Tract Urothelial Carcinoma (UTUC)

Description of Research Study: The MitoGel™ treatment is delivered directly to the tumor area through a catheter in its liquid form, then turns to gel in the upper urinary tract. This slows down the loss of the drug, which would normally occur during regular urination. The gel helps keep the chemotherapy in direct contact with the tumor for several hours, which increases its efficacy and is an improvement from current chemotherapy treatments. The purpose of this study is to evaluate the possible benefits, risks and tolerability of MitoGel™ in UTUC patients. Information about any side affects you experience will also be collected.
Principal Investigator: Marc Dall'Era, M.D., Department of Urologic Surgery
Co-Investigator: Christopher P. Evans, M.D., F.A.C.S., Department of Urologic Surgery
Research Coordinator: Randev Sandhu CCRP, Department of Urologic Surgery

A Study of Intravesical Bacillus Calmette-Guerin (BCG) in Combination with ALT-803 in Patients with Non-Muscle Invasive Bladder Cancer (NMIBC)

Description of Research Study: The purpose of this research Study is to test the effectiveness of the combination treatment, ALT-803, plus BCG compared to treatment with BCG alone, in patients with BCG Naive NMIBC.
Principal Investigator: Marc Dall'Era, M.D., Department of Urologic Surgery
Co-Investigator: Christopher P. Evans, M.D., F.A.C.S., Department of Urologic Surgery
Research Coordinator: Randev Sandhu CCRP, Department of Urologic Surgery

Prospective Validation of Prostate Biomarkers for Repeat Biopsy (PRIORITY Study)

Description of Research Study: This study is being conducted to evaluate the performance of the ConfirmMDx test for Prostate Cancer, and the SelectMDx test for Prostate Cancer to identify patients with increased risk for clinical significant disease, and to lower the rate of repeat biopsies.
Principal Investigator: Marc Dall'Era, M.D., Department of Urologic Surgery
Co-Investigator: Christopher P. Evans, M.D., F.A.C.S., Department of Urologic Surgery
Research Coordinator: Randev Sandhu CCRP, Department of Urologic Surgery

UC - Davis GenitoUrinary (GU) Biospecimen Collections (Tissue, Blood and Urine)

Description of Research Study: Collection of biological specimens would consist of left-over surgical or biopsy tissue, blood or urine. These biological specimens will be collected, processed and/or stored in a research-only tissue bank for future research studies.
Principal Investigator: Marc Dall'Era, M.D., Department of Urologic Surgery
Co-Investigator: Christopher P. Evans, M.D., F.A.C.S., Department of Urologic Surgery
Research Coordinator: Randev Sandhu CCRP, Department of Urologic Surgery

Localized Prostate Cancer Pathway Protocol

Description of Research Study: The purpose of this research is to collect patient clinical information and biospecimens (tumor, blood and other biologic specimens) to better determine if standard therapy for prostate cancer at UC Davis meets standard benchmarks established by randomized clinical trials.
Principal Investigator: Marc Dall'Era, M.D., Department of Urologic Surgery
Co-Investigator: Christopher P. Evans, M.D., F.A.C.S., Department of Urologic Surgery
Research Coordinator: Randev Sandhu CCRP, Department of Urologic Surgery

Bladder Cancer Pathway Protocol (BCPP)

Description of Research Study: The purpose of this research is to collect patient clinical information and biospecimens (tumor, blood and other biologic specimens) to better determine if standard therapy for bladder cancer at UC Davis meets standard benchmarks established by randomized clinical trials.
Principal Investigator: Marc Dall'Era, M.D., Department of Urologic Surgery
Co-Investigator: Christopher P. Evans, M.D., F.A.C.S., Department of Urologic Surgery
Research Coordinator: Randev Sandhu CCRP, Department of Urologic Surgery

Assessment of Under-Treatment of LUTS in the Geriatric Population

Description of Research Study: This study seeks to identify the prevalence of lower urinary tract symptoms (LUTS) secondary to bladder outlet obstruction (BOO), severity of symptom bother, and nature of treatment within the geriatric population.
Principal Investigator: Robert Lurvey, M.D., Department of Urologic Surgery
Co-Investigator: Gregory Amend, M.D., Department of Urologic Surgery
Research Coordinator: Randev Sandhu, CCRP, Department of Urologic Surgery

Ultrasound-guided Suprapubic Catheter Training Model – Improving Patient Safety at Minimal Cost

Description of Research Study: The purpose of this study is to develop a cost effective simulator to train Residents on suprapubic catheter placement.
Principal Investigator: Jennifer Yang, M.D., Department of Urologic Surgery
Co-Investigator: Roland Palvolgyi, M.D., Department of Urologic Surgery
Research Coordinator: Randev Sandhu, CCRP, Department of Urologic Surgery