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

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

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

CISTO Study – NMIBC

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

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PI: Kristen Scarpato, MD

EDRN – MRI Study

NCI Early Detection Research Network – EDRN Prostate MRI Biomarker Study and Reference Set.

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PI: Dan Barocas, 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

Medtronic Registry Study

Medtronic Product Surveillance Registry (PSR).

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PI: Melissa Kaufman, 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

Botox Injection Antibiotic Study

Comparison of Methods for Prevention of Urinary Tract Infection Following Botox Injection:  A Non-Inferiority Trial.

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PI: Melissa Kaufman, 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

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

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

Struvite Stones Antibiotic

The aim of this research is to determine an effective antibiotic regimen following definitive surgical therapy of kidney stones caused by bacterial infection (struvite stones).

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PI: Ryan Hsi, MD; Nicole Miller, MD

AUSCO - AMS 800

Artificial Urinary Sphincter Clinical Outcomes (AUSCO)

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PI: Niels Johnsen, 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

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

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

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

Reloxaliase Phase III RCT

Establishing the Safety and Efficacy of Reloxaliase in Patients With Enteric Hyperoxaluria (URIROX-2)

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PI: Edward Gould, MD

Mini-PCNL vs Standard PCNL

Standard vs Mini-PCNL for the Treatment of Stone Disease

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PI: Nicole Miller, MD

Enrollment Closed, Study In-Progress

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

PROSTQA-RP2

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

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PI: Joseph Smith, 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

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

Taris Biomedical-MIBC

A Multicenter Study Evaluating Safety and Efficacy of TAR-200 in Subjects with Muscle-Invasive Urothelial Carcinoma of The Bladder Who are Ineligible for or Refuse Cisplatin-based Chemotherapy and Who are Unfit for Radical Cystectomy

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PI: Amy Luckenbaugh, MD

Profound-TULSA PRO

Evaluation of the TULSA-PRO MRI-Guided Transurethral Ultrasound Prostate Ablation Device in Patients with localized Prostate Cancer: A Prospective, Single-Arm, Pivotal Clinical Study

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PI: David Penson, MD

MDx Health - Hematuria

Multi-institutional study to evaluate DNA methylation markers for detection of primary bladder cancers in urine samples from a cohort of patients with hematuria.

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PI: Kristen Scarpato, 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