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.
Title: A Phase 3 Randomized, Double-Blind Study of Nivolumab or Placebo in Combination with Docetaxel, in Men with Metastatic Castration-resistant Prostate Cancer (CheckMate 7DX: CHECKpoint pathway and nivoluMAB clinical Trial Evaluation 7DX)
Summary: The purpose of the study is to determine if treating men with castrate-resistant prostate cancer (mCRPC) with nivolumab in combination with docetaxel improves progression-free survival compared to treatment with docetaxel alone.
Title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Who are Candidates for Radical Prostatectomy
Summary: The purpose of the study is to determine if treatment with apalutamide plus androgen deprivation therapy before and after radical prostatectomy with pelvic lymph node dissection in subjects with high-risk localized or locally advanced prostate cancer is an improvement in pathological complete response rate and metastasis-free survival based on conventional imaging, when compared to placebo plus androgen deprivation therapy.
Title: A Multi-center, Open-label, Single-arm Phase 2 Study of the Adjuvant Treatment of Apalutamide and Androgen Deprivation Therapy (ADT) in Treatment-naïve Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases
Summary: The purpose of the study it to determine if the combination of apalutamide and androgen deprivation therapy in participants with high-risk localized prostate cancer improves the Biochemical Recurrence-free rate.
Title: A Phase 3, Randomized, Open-Label, Controlled Study of Cabozantinib (XL184) in Combination with Atezolizumab vs Second Novel Hormonal Therapy (NHT) in Subjects with Metastatic Castration-Resistant Prostate Cancer
Summary: The purpose of the study is to determine the efficacy of treatment with cabozantinib combined with atezolizumab compared to treatment with a second novel hormonal therapy in subjects with metastatic castration resistant prostate cancer.
Title: ESCALATE, A Phase III Randomized Study Comparing Enzalutamide or Darolutamide with Radium-223 vs Enzalutamide or Darolutamide with Placebo and the Effect upon Symptomatic Skeletal Event-Free Survival for mCRPC Patients
Summary: The purpose of this study is to determine if treatment with radium-223 following 16 weeks of enzalutamide or darolutamide treatment in patients demonstrating a biochemical response improves disease outcomes.
Title: A Randomized, Double-blind, Placebo-controlled, Multicentre Phase III Study of Olaparib Plus Abiraterone versus Placebo Abiraterone as First-line Therapy in Men with Metastatic Castration-resistant Prostate Cancer
Summary: The purpose of the study is to detrmine the efficacy of olaparib+abiraterone combination therapy compared to placebo+abiraterone in patients with metastatic castrate-resistant prostate cancer.
Title: A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Subjects with Metastatic Prostate Cancer
Summary: The purpose of the study is to determine if niraparib plus abiraterone acetate and prednisone(AA-P) will improve radiographic progression-free survival (rPFS) compared to placebo plus AA-P in subjects with L1 metastatic castrate-resistant prostate cancer (mCRPC) and HRR gene alterations or in subjects with a prespecified subset of HRR gene alterations.
A second purpose of the study is to determine if niraparib plus AA-P will improve rPFS compared to a placebo plus AA-P in subjects with L1 mCRPC with or without HRR gene alterations.
Title: A Phase 1B/2 Open-label Study Evaluating Tazemetostat in Combination with Enzalutamide or Abiraterone/Prednisone in Chemotherapy Naïve Subjects with Metastatic Castration-Resistant Prostate Cancer
Summary: The purpose of the Phase 2 study is to determine the benefit of combining tazemetostat with enzalutamide compared to enzalutamide alone in length of radiographic progression-free survival (rPFS) according to Prostate Cancer Clinical Trials Working Group 3 criteria for progression in bone or in soft tissue.
Title: PROCADE: A Multinational, Phase 3, Randomized, Double-Blind, Non-Inferiority, Efficacy and Safety Study of Oral HC-1119 versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Summary: The purpose of this study is to determine the efficacy of the study drug, HC-1119, for overall response rate and as compared to enzalutamide for achieving a ≥ 50% decline in PSA50.
Title: A Phase 3, Randomized, Double-Blind, Placebo-controlled Study of Talazoparib in Combination with Physician’s choice of Enzalutamide or Abiraterone Acetate/Prednisone in Metastatic Castration-resistant Prostate Cancer with DNA Damage Repair Deficiencies
Summary: The purpose of the study is to confirm that 1mg per day as the starting dose of talazoparib for each treatment combination during Part 2 (double-blind treatment period. A second purpose of the study is to characterize talazoparib and Novel Hormone Therapy pharmacokinetics when dosed in combination.
Title: A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants with Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Summary: The purpose of the study is to determine if niraparib, abiraterone acetate and prednisone improves radiologic progression free survival in participants with deleterious germline or somatic HRR gene-mutated metastatic castration-sensitive prostate cancer.
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.
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.
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.
Title: Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of Infigratinib for the Adjuvant Treatment of Subjects with Invasive Urothelial Carcinoma with Susceptible FGFR3 Genetic Alterations (PROOF 302)
Summary: The purpose of the study is to determine if treatment with infigratinib improves disease-free survival (DFS) compared with placebo treatment in subjects with invasive urothelial carcinoma with susceptible FGFR3 alterations after nephroureterectomy, distal ureterectomy, or cystectomy
Title: A Randomized Phase 2 Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Subjects Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) and FGFR Mutations or Fusions
Summary: The purpose of the study is to determine if treatment with erdafitinib reduces tumor recurrence compared to intravesical chemotherapies in patients with high-risk non-muscle invasive bladder cancer (NMIBC) who also have FGFR mutations or fusion whose cancer has recurred after Bacillus Calmette-Guerin (BCG) therapy.
Title: Phase 2b Clinical Study Evaluating Efficacy and Safety of TAR-200 in Combination with Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants with High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guerin (BCG) who are Ineligible for or Elected Not to Undergo Radical Cystectomy
Summary: The purpose of the study is to compare the overall response to treatment between 3 different treatments: 1) participants treated with the investigational device TAR-200/gemcitabine in combination with cetrelimab, or 2) participants treated with TAR-200/gemcitabine alone or 3) cetrelimab alone. The study will include patients with Carcinoma in Situ (CIS), with or without concomitant high-grade Ta or T1 papillary disease.
Title: A Phase 3, Multi-center, Randomized Study Evaluating Efficacy of TAR-200 in Combination with Cetrelimab Versus Concurrent Chemoradiotherapy in Participants with Muscle-Invasive Urothelial Carcinoma (MIBC) of the Bladder who are not Receiving Radical Cystectomy
Summary: The purpose of the study is to compare bladder intact event-free survival between participants receiving TAR-200 in combination with cetrelimab and participants receiving chemotherapy and radiation treatment.
Title: A Randomized Phase 2 Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Subjects Who Received Bacillus Calmette-Guerin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) and FGFR Mutations or Fusions
Summary: The purpose of the study is to compare the rate of recurrence free survival between treatment with erdafitinib compared to Investigator’s Choice of treatment for participants with high-risk NMIBC who harbor FGFR mutations or fusions, and who recurred after Bacillus Calmette-Guerin therapy.
Title: Phase I Safety and Tolerability of Intravesical VAX014 for Instillation in Subjects with Non-Muscle Invasive Bladder Cancer (NMIBC)
Summary: The purpose of the study is to determine the maximum tolerated dose (MTD) [or maximum practical dose (MPD)] of intravesical VAX014 and to determine the safety profile of intravesical VAX014.
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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