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. 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. Sponsor satisfaction with our team is consistently high, frequently resulting in subsequent trials with the same sponsor(s).

Below is a list of our active clinical trials.

Currently Enrolling Patients

Bond 003

To evaluate the activity of intravesical (IVE) administration of CG0070 in patients with tissue pathology confirmed non-muscular invasive bladder cancer (NMIBC) who have Bacillus-Calmette-Guerin (BCG) unresponsive disease, with either carcinoma in situ with or without Ta/T1 disease

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PI: Amy Luckenbaugh, MD

CISTO Study – NMIBC

The Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer.

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PI: Kristen Scarpato, MD

Cook Myosite

CELLEBRATE:  An Adaptive, Two-Stage, Double-Blind, Stratified, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR with Placebo in Female Subjects with Stress Urinary Incontinence.

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PI: Roger Dmochowski, MD

CxBladder

Use of a Multiplexed Molecular Biomarker Test Cxbladder, in Real World Decision Making to Provide Clinical Utility Using a Randomized Design.

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PI: Kristen Scarpato, MD

DAROL

A Study in Which Non-metastatic Castration-Resistant Prostate Cancer (nmCRPC) Patients for Whom a Decision to Treat with Darolutamide has been Made Before Enrollment are Observed and Certain Outcomes are Described

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PI: Kelvin Moses, MD

Empiric Versus Selective Prevention Strategies for Kidney Stone Disease

The aims of this study are to conduct a clinical trial comparing two major strategies for kidney stone prevention.

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PI: Ryan Hsi, MD

Female Cystectomy

Sexual Function in Women after Radical Cystectomy.

PI: Amy Luckenbaugh, MD

Image Guided Surgery for Partial Nephrectomy

Patient-specific, touch-based registration during robotic, image-guided partial nephrectomy

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PI: Duke Herrell, MD

MDx Health – PRIORITY Study

Prospective Validation of Prostate Biomarkers for Repeat Biopsy:  The PRIORITY Study.

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PI: Sam S. Chang, MD

Medtronic Registry Study

Medtronic Product Surveillance Registry (PSR).

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PI: Melissa Kaufman, MD

Mini-PCNL vs Standard PCNL

Standard vs Mini-PCNL for the Treatment of Stone Disease

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PI: Nicole Miller, MD

MOSES in Stone URS RCT

A Comparison of Ureteroscopic Treatment of Nephrolithiasis With and Without Moses Technology

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PI: Nicole Miller, MD

Recurrent UTIs and Kidney Stones

Asymptomatic Renal Calculi in Recurrent Urinary Tract Infections. This study will assess patients who have recurrent urinary tract infections and kidney stones which are not blocking the kidney or causing other problems.

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PI: Ryan Hsi, MD

Ureteral Stent Trial

Ureteral Stent Placement After Ureteroscopy for Renal Stones: A Randomized Controlled Trial. The rationale for this study is to determine if there is a difference in complications among patients undergoing ureteroscopy for renal stones who receive a stent compared to not receiving a stent postoperatively.

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PI: Ryan Hsi, MD

Enrollment Closed, Study In-Progress

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.

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PI: Sam S. Chang, MD

AUSCO - AMS 800

Artificial Urinary Sphincter Clinical Outcomes (AUSCO)

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PI: Niels Johnsen, MD

Dendreon Active Surveillance

A Randomized Phase 3, Open-Label Trial of Sipuleucel-T Administered to Patients on Active Surveillance for Newly Diagnosed Prostate cancer, Protocol P17-1

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PI: Kelvin Moses, MD

EMBARK: Medivation

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

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PI: David Penson, MD

FKD Therapies/Instiladrin

A Phase III, Open Label Study to Evaluate the Safety and Efficacy of INSTILADRIN (rAd-IFN/Syn3) Administered Intravesically to Patients with High Grade, BCG Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)

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PI: Amy Luckenbaugh, MD

Janssen

Neo-adjuvant and adjuvant apalutamide/placebo plus ADT in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Who are Candidates for Radical Prostatectomy

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PI: Kelvin Moses, MD

Kidney Stone Pain (ENORC)

Evaluation of Pain Before and After Removal of Non-obstructive Kidney Stones (ENORC).  The objective of this study is to prospectively determine if the removal of non-obstructing renal calculi can reduce or eliminate participant's pain and/or improve their quality of life.

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PI: Ryan Hsi, MD

Medtronic ELITE

InterStim Micro Post Market Clinical Follow-up Study (ELITE)

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PI: Melissa Kaufman, MD

Myriad Prolaris

Long-Term Prospective Registry in Prostate Cancer Patients from Diverse Urology Practice Settings Following Prolaris Testing

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PI: Kelvin Moses, MD

PhageTech

To evaluate the effectiveness of the PhageTech Virus BioResistor to detect bladder cancer biomarkers.

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PI: Kristen Scarpato, MD

PROSPER: Medivation

A Multinational, Phase 3, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer

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PI: David Penson, MD

PROSTQA-RP2

Effectiveness of Open and Robotic Prostatectomy: The PROSTQA-RP2 Cohort Study

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PI: Joseph Smith, MD