The TUCC Clinical Research Department, led by Dr. Lawrence Karsh, participates in all phases of clinical trials. Combined, our research staff has more than 20 years of experience. In 2008, the Clinical Research Department was awarded acceptance into the Society of Urologic Oncology Clinical Trials Consortium. TUCC is one of only 22 large urology groups in the country with this designation. In addition, TUCC is an appointed, certified site for the South West Oncology Group (SWOG) to conduct bladder cancer clinical trials. In 2013 TUCC applied for an obtained accreditation as one of the few community sites with a biolevel 2 site (accredited to conduct research studies involving gene therapy). Participation in clinical research studies is critical to the development of new standards of care. At TUCC, our research department is proud to provide patients with access to tomorrow’s urologic therapies today. Dr. Lawrence Karsh, M.D., F.A.C.S., Director of Clinical Research
Clinical trials are designed by physicians and researchers to test new medical therapies. Depending on the study, these trials may give patients access to new investigational drugs and methods of care. The safety and privacy of clinical trial participants are protected through the Food and Drug Administration (FDA), the governing agency for all medical research. An independent Institutional Review Board (IRB) also reviews clinical trial related documents and procedures for patient safety and protection. Patients who wish to enroll in a research study should discuss the possibilities with their urologist. The TUCC Clinical Research Department staff remains in constant communication with patients throughout their enrollment in clinical trials. These patients receive all study related medication and procedures at no cost. Participation is voluntary and patients can choose to withdraw from clinical trials at any time. Please note that all clinical studies at TUCC are voluntary, meaning that patients may drop out of the study at any time. All study procedures and medication will be provided to patients free of charge.
• Enzalutamide in Patients with Localized Prostate Cancer Undergoing Active Surveillance – Active, recruiting new patients A study for men diagnosed with early stage (localized) prostate cancer and are undergoing active surveillance (being observed over time to see if your prostate cancer changes). The purpose of this study is to see if enzalutamide, an approved product for treating prostate cancer in advanced stages, can delay the progression of early stage prostate cancer. • Niraparib for the treatment of Advanced Prostate Cancer – Active, recruiting new patients A Phase 2 efficacy and safety study of Niraparib in men with metastatic castration- resistant prostate cancer and DNA-repair anomalies. The main purpose of this study is to see if Niraparib is useful to treat men with advanced prostate cancer. The safety of niraparib will also be studied. • Phase III Prostate Cancer Clinical Trial – Active, recruiting new patients The purpose of this trial is to test if a marketed drug for advanced prostate cancer (FIRMAGON) can reduce the risk of cardiovascular complications as compared to another marketed drug for advanced prostate cancer (LUPRON DEPOT) in patients with prostate cancer and cardiovascular disease. • A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer – Active, recruiting new patients The purpose of this study is to determine the benefit and safety of relugolix 120 mg orally once daily for 48 weeks on maintaining serum testosterone suppression to castrate levels (<=50 ng/dL [1.7 nmol/L] in patients with androgen-sensitive advanced prostate cancer. • An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies – Active, recruiting new patients The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of niraparib in men with metastatic castration resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies. • Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC With Deoxyribonucleic Acid (DNA) Damage Repair Deficiencies (DDR) – Active, recruiting new patients This study compares rPFS in men with DDR deficiency(ies) mCRPC treated with talazoparib plus enzalutamide vs. enzalutamide after confirmation of the starting dose of talazoparib in combination with enzalutamide. • A Study of Intravesical Qapzola (Apaziquone) as a Surgical Adjuvant in Patients Undergoing TURBT – Active, recruiting new patients This is a randomized, multicenter, two-arm, double-blind, placebo-controlled study of Qapzola in patients with low- to intermediate-risk NMIBC, assessed according to the 2016 American Urology Association (AUA) Guidelines. Specifically, only patients with the following low-to intermediate risk tumor characteristics will be included in the study.
Interested in finding out more about clinical trials at TUCC? Please fill out the following form and you will receive a response within one business day.
• It gives you another option or enhancement to your treatment plan. • It will help you feel more proactive about your disease process. • It will increase your knowledge base about your disease. • Data collected from your participation will help others in the future with the same diagnosis. • All study medication and study procedures will be provided to you at no cost.
• Compliance with the guidelines of the study. • Compliance with study prescription medication. • Regular communication in study diaries and/or questionnaires. • The ability to come to study visits during specific windows of time. • An understanding that any study is voluntary and a study participant may withdraw consent at any time.
The number one priority of the research team is patient safety. The research team is responsible for making sure the study participant is following the guidelines of the study. The research team is also expected to track any side effects and ensure follow up of episodes and they are responsible for making sure the study participant’s needs are being met within the confines of the study.
Dr. Karsh is a Certified Principal Investigator and the primary investigator of research studies at TUCC. He is a co-founder of The Urology Center of Colorado where he serves as an attending Urologist, Director of Research & Co-Chairman of Advanced Therapeutic Clinic. He has been the principle investigator for over 250 clinical trials. Dr. Karsh has authored a number of peer-reviewed publications and serves on the editorial boards for Oncology Live, Urologist and Cancer Care, and Bladder Cancer. He is a fellow of the American College of Surgeons, and an active member AUA, SUO, ASCO, SWOG, ACS, and the Denver Academy of Surgeons. He serves on the bladder cancer subcommittee and is on the advisory board for the SUO Clinical Trials Consortium and a member of the Bladder Cancer Advocacy Network (BCAN) Think Tank. Dr. Karsh completed his General Surgery training at The University of Colorado Health Sciences Center (UCHSC) and his Urology residency at Brigham and Women’s Hospital/Harvard Medical School. He is an associate clinical professor of surgery at UCHSC. Dr. Karsh participates in many advisory boards for new drug development. He lectures and teaches at scientific meetings throughout the country.
Robin is a certified clinical research coordinator with a degree in biology and minor in holistic health. She also holds certifications as a medical assistant, emergency medical technician and is IV certified. She has worked in the health care industry for 35 years and has 20 years of experience in clinical research. She has completed over 150 clinical studies in the therapeutic areas of endocrinology, GI, respiratory, dermatology, cardiovascular, neurology and urology. Robin has experience with phase I-V and investigation driven studies. For the past nine years she has served as the Site Manager for the TUCC Clinical Research Department. Robin is married with three grown children and three grandchildren.
TUCC physicians Juan Montoya, M.D., Eric Gross, M.D., Lawrence Karsh, M.D., published in The Canadian Journal of Urology International, 2018 Read Article
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