Innovation: Urologic Oncology: Clinical Trials

Clinical Trials

The Department of Urology has over 20 years of experience in human-studies research and conducting clinical trials in a number of disease areas, particularly in urologic oncology. Approximately 150 trials have been completed with enrollment on target. These trials have included investigator-initiated and industry trials.  We have worked with most of the major pharmaceutical companies in all phases of the clinical trial spectrum and sponsor satisfaction with our team has been great enough that we are selected for subsequent trials with the same sponsor. In the last 5 years, the Department was a recruiting site for 24 industry sponsored clinical trials. The therapeutic areas include:

  • Prostate cancer (newly diagnosed, rising PSA after definitive treatment, CRPC) 
  • Bladder cancer (NMIBC and MIBC) 
  • Kidney cancer 
  • Benign urology, including voiding Dysfunction (OAB, SUI) and erectile dysfunction

We successfully completed the MTOPS, PCPT, and SELECT trials with 150+, 300+, and 100+ respectively enrolled.

Our urologic oncology faculty constantly studies new ways to prevent, detect and treat urologic cancers. We work with researchers and investigators throughout Vanderbilt and many other institutions on multiple urologic oncology clinical trials. Visit the Vanderbilt clinical trials page to learn more.
 
Our clinical trials include:

  • Altor - QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BHG) in Combination with ALT-803 in Patients with BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer – CA-ALT-803-01-16.  PI:  Sam Chang, MD; Clinical Coordinator:  Bree Leidy, RN Begin Date:  8/24/2018 Target enrollment:  9 (increased enrollment target on 6/7/19) Enrolled:  7 
     
  • MCT Study - MIBC: Feasibility Study of Motility Contrast Tomography for Predicting Therapeutic Response Among Bladder Cancer Patients Receiving Neoadjuvant Chemotherapy.  PI:  Aaron Laviana, MD; Clinical Coordinator:  Pam Steele, RN Begin Date:  10/30/2018 Target enrollment:  30 Enrolled:  18 
     
  • Talapro-2 (Pfizer): Newly diagnosed mCRPC (no prior systemic therapy in this state) to receive enza +/- talazoparib, primary outcome rPFS, secondary outcome OS) PI:  Kelvin Moses, MD; Coordinators:  Pam Steele/Bree Leidy. Begin Date:  6/2019 Target Enrollment:  3 Enrolled:  0
     
  • ProStar (Constellation Pharmaceuticals): Phase 2 (mCRPC), CPI-1205 (selective EZH2 inhibitor) with abiraterone for those who previously took enza for at least 24 weeks or CPI-1205 with enza for those who previously took abi for at least 24 weeks. PI:  Kelvin Moses, MD; Coordinators:  Pam Steele/Bree Leidy. Begin Date:  6/2019 Target Enrollment:  4 Enrolled:  0
     
  • Movember: Patients with localized prostate cancer to study patient reported outcomes as part of an international quality collaborative. PI: Dan Barocas, MD; Coordinator:  PSR staff will be giving out the questionnaires. New patients will fill out the EPIC + AUA SI and follow up patients will fill out the EPIC only Begin Date:  3/20/17 Target Enrollment:  550/yr. Enrolled:  876
     
  • Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial). This National Cancer Institute trial studies how well treatment directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment that targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities may help doctors plan better and more personalized treatment for patients with solid tumors, lymphomas, or multiple myeloma. Investigator:
     
  • Study of the Safety, Tolerability and Efficacy of KPT-8602 in Patients With Relapsed/Refractory Cancer Indications. This is a first-in-human, multi-center, open-label clinical study with separate dose escalation (Phase 1) and expansion (Phase 2) stages to assess preliminary safety, tolerability, and efficacy of the second generation oral XPO1 inhibitor KPT-8602 in patients with relapsed/refractory multiple myeloma (MM), metastatic colorectal cancer (mCRC), metastatic castration resistant prostate cancer (mCRPC), and higher risk myelodysplastic syndrome (HR-MDS). Dose escalation and dose expansion may be included for all parts of the study as determined by ongoing study results. This study is currently closed for enrollment for patients with relapsed/refractory multiple myeloma (MM), metastatic or colorectal cancer (mCRC), and metastatic castration resistant prostate cancer (mCRPC). Investigator:
     
  • Cognitive Effects of Androgen Receptor Directed Therapies for Advanced Prostate Cancer. This clinical trial studies cognitive function in men with prostate cancer treated with androgen receptor directed therapies such as abiraterone acetate and enzalutamide. The investigators use MRI imaging (non-invasive, non-contrast) to see whether there are changes in brain structure or activity related to treatment that may be related to changes in cognitive function. The investigators are also looking for genetic variations that might make patients more or less sensitive to cognitive changes during treatment for prostate cancer. Investigator:
     
  • Cisplatin and Gemcitabine Hydrochloride with or without ATR Kinase Inhibitor M6620 in Treating Patients with Metastatic Urothelial Cancer. This randomized phase II trial studies how well cisplatin and gemcitabine hydrochloride with or without ATR kinase inhibitor M6620 works in treating patients with urothelial cancer that has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as cisplatin and gemcitabine hydrochloride, 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. ATR kinase inhibitor M6620 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if cisplatin and gemcitabine hydrochloride work better alone or with ATR kinase inhibitor M6620 in treating patients with urothelial cancer. Investigator: Nancy Davis
     
  • Neratinib HER Mutation Basket Study (SUMMIT). This is an open-label, non-randomized, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in patients with ERBB mutation-positive or EGFR gene-amplified solid tumors. Investigator: Ingrid Mayer
     
  • Cognitive Assessment and MRI Program in Identifying Cognitive Effects of Androgen Receptor Directed Therapies in Patients with Advanced Prostate Cancer. This clinical trial studies how well cognitive assessment and magnetic resonance imaging (MRI) program work in identifying cognitive effects of androgen receptor directed therapies such as abiraterone acetate and enzalutamide in patients with prostate cancer that has spread from where it started to other places in the body. Cognitive assessment and MRI program may help to assess the cognitive function of patients during treatment and identify genetic variations that might make patients more or less sensitive to cognitive changes during treatment for prostate cancer. Investigator: Kelvin Moses
     
  • Sapanisertib in Treating Patients with Locally Advanced or Metastatic Bladder Cancer with TSC1 and / or TSC2 Mutations. This pilot phase II trial studies how well sapanisertib works in treating patients with bladder cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic) with tuberous sclerosis (TSC)1 and / or TSC2 mutations (changes in deoxyribonucleic acid [DNA]). Sapanisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Investigator: Nancy Davis
     
  • Prospective Validation of Prostate Biomarkers for Repeat Biopsy: The PRIORITY Study. Investigator: Sam Chang 
     
  • Vanderbilt Assessment of Shed ALCAM in Urogenital Cancers (VanSA). This is a basic science study. Investigator: Shanna Arnold
     
  • Prospective Observational Trial of an Absorbable Hydrogel Spacer in Prostate Cancer Radiotherapy. Investigator: Austin Kirschner
     
  • MRI-Ultrasound Fusion Targeted Prostate Biopsies - Quality Control & Performance Improvement. Investigator: Daniel Barocas