Clinical Trials

Physicians at Columbia Urology are also faculty members at Columbia University Vagelos College of Physicians and Surgeons where they conduct clinical trials on a range of novel and promising treatments for urologic disorders. Our researchers often conduct research collaboratively with each other and with other departments, as part of our comprehensive and integrated research program.

Our clinical studies have already advanced our understanding and treatment of a broad range of urologic disorders. Through clinical trials physicians in our department helped develop the tools and techniques now widely used for robotic prostatectomy and minimally invasive partial nephrectomy, new treatments for kidney cancer, and through our holistic urology program we are testing herbal and naturopathic treatments for a number or urologic problems.

Current Clinical Trials

A Phase 1/2 trial for the use of Intravesical Cabazitaxel, Gemcitabine, and Cisplatin (CGC) in the treatment of BCG-Refractory Non-muscle invasive Urothelial Carcinoma of the Bladder

The investigators intend to evaluate the safety and toxicity profile of intravesically administered multidrug regimen of Cabazitaxel, Cisplatin and Gemcitabine in treatment refractory Transitional Cell Carcinoma.The investigators propose to conduct a combined phase I trial to assess the safety, toxicity, and efficacy of a novel multidrug intravesical regimen consisting of Cabazitaxel, Gemcitabine, and Cisplatin (CGC) in the treatment of BCG resistant non-muscle invasive urothelial carcinoma of the bladder. This phase I trial will have a combined dose and cycle-escalation scheme with enrollment of up to 24 patients.

PI: James McKiernan, MD


Phase 1/2 Study of Modern Immunotherapy in BCG-Relapsing Urothelial Carcinoma of the Bladder

A multi-arm multi-stage (MAMS) phase 1/2 study. Phase 1 will be conducted in BCG-unresponsive NMIBC patients to establish the safety of durvalumab monotherapy (cohort 1) and durvalumab in combination with BCG (cohort 2a) and external beam radiation therapy (EBRT) (cohort 2b).

PI: Christopher B Anderson, MD


Re-establishing flow via drug-coated balloon for treatment of Urethral Stricture – A Randomized Controlled Trial

ROBUST III is a prospective, multi-center, randomized controlled adaptive sample size clinical trial to establish the safety and effectiveness for the Optilume Stricture Drug Coated Balloon (DCB).

PI: Steven B. Brandes, MD


A Prospective, Open, Comparative, Within Patient Controlled Multicenter Phase 3 Study of Blue Light Cystoscopy With Cysview and White Light Cystoscopy Using KARL STORZ D-Light C PDD Flexible Videoscope System in Detection of Bladder Cancer in Patients With Bladder Cancer

The purpose of this study is to investigate if blue light cystoscopy with Cysview improves detection of tumors in patients with bladder cancer during surveillance cystoscopy, using the KARL STORZ D-Light C PDD Flexible Videoscope System. Another purpose is to investigate if Cysview and blue light is safe and effective when used repeatedly.

PI: Guarionex Joel DeCastro, MD


Multi-Institutional Study to Evaluate DNA Methylation Markers for Detection of Primary Bladder Cancers in Urine Samples from a Cohort of Patients With Hematuria

PI: Guarionex Joel DeCastro, MD

(P&S Industry Clinical Trial)

Phase 1/2 Trial Evaluating the Safety and Tolerability of NanoDoce® Injection and Intravesical Instillation in Subjects with Urothelial Carcinoma

This is a clinical trial studying the administration of NanoDoce as a direct injection to the bladder wall immediately after tumor resection and as an intravesical instillation. All participants will receive NanoDoce, and will be evaluated for safety and tolerability, as well as the potential effects of NanoDoce on urothelial carcinoma.

PI: Guarionex Joel DeCastro, MD


An Open-Label, Multicenter, Phase 3 Study to Evaluate the Efficacy and Tolerability of Intravesical Vicinium™ in Subjects with Non Muscle-Invasive Carcinoma in Situ (CIS) and/or High-Grade Papillary Disease of the Bladder Previously Treated with Bacillus Calmette-Guérin (BCG)

Because of the high risk for development of muscle invasive disease, cystectomy is recommended for CIS, high-grade Ta and T1 patients who experience disease recurrence following intravesical therapy. Vicinium is an experimental agent that may provide an alternative to cystectomy.

PI: Guarionex Joel DeCastro, MD


A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Evaluate Efficacy, Safety & Tolerability of Vibegron in Men with OAB Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)

This study will assess the efficacy of vibegron compared with placebo in men with overactive bladder (OAB) symptoms on pharmacological therapy for benign prostatic hyperplasia (BPH) as defined by micturition and urgency episodes.

PI: Matthew Rutman, MD


Establishing the Safety and Efficacy of Reloxaliase (oxalate decarboxylase) in patients with Enteric Hyperoxaluria: Phase III RPCT (URIROX-2)

This is a phase 3, global, multi-center, randomized, double-blind, placebo-controlled study. This study is designed to determine the short- and long-term efficacy of reloxaliase in terms of reducing urinary oxalate excretion and clinical benefits compared to placebo.

PI: Ojas Shah, MD


Prospective Randomized Double Blind Clinical Trial To Compare Holmium Laser Lithotripsy With and Without Moses Laser Technology For The Ureteroscopic Treatment of Nephrolithiasis

The purpose of this study is to evaluate the potential of Moses laser technology to reduce operative time compared to non-Moses settings for ureteroscopic treatment of nephrolithiasis.

PI: Ojas Shah, MD


Effect of Antihistamines on Ureteral Stent-Related Symptoms: Randomized Controlled Trial

This is a prospective, double-blind, randomized, open-label, single-center trial of up to 78 participants who are adult patients (aged 18-80 years) and are undergoing unilateral retrograde ureteroscopy with planned ureteral stent placement for treatment of urinary tract stones.

PI: Ojas Shah, MD


Boston Scientific Double-J PLUS Ureteral Stent Postmarket Patient Registry

A multi-center global registry to obtain post-market safety and efficacy data on Boston Scientific Ureteral and Urinary Diversion Stents.

PI: Ojas Shah, MD


Clinical Evaluation of the 'ExoDx Prostate IntelliScore' in Men Presenting for Initial Biopsy; Additional Confirmation Study Including Impact on Decision-making and Health Economics

The purpose of this research study is to investigate a new and validated urine test which predicts the likelihood of high grade prostate cancer on an initial prostate biopsy.

PI: Sven Wenske, MD


Prospective Validation of Prostate Biomarkers for Repeat Biopsy (PRIORITY)

This study is being conducted to evaluate the performance of the ConfirmMDx and SelectMDx tests for Prostate Cancer to identify patients with increased risk for clinically significant disease, to ultimately lower the rate of repeat biopsies. Approximately 1000 people are expected to take part in this study.

PI: Sven Wenske, MD