At Urology of Virginia, research studies form a vital component of our mission. These studies, referred to as clinical trials, are designed by physicians and researchers to investigate new medical therapies. Well-designed clinical trials offer the newest, most promising drugs and treatments for urological conditions to our community.
Our staff’s experienced investigators and certified clinical research coordinators closely monitor participating patients during the course of a study period. All clinical trials are conducted according to the principles of Good Clinical Practice (GCPs) as mandated by the FDA.
For questions and information about our clinical trials, please contact us at research@urologyofva.net
- Participants have access to advanced medications or devices before they become available to the public.
- Clinical study procedures may be provided to you at no cost.
- Participants often express enthusiasm for contributing to medical science.
- Today’s clinical research can positively impact future generations.
Enrolling Clinical Studies at Urology of Virginia
In this study, participants with high risk non-muscle-invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG) therapy and who are considered ineligible for or have refused to undergo radical cystectomy, will receive pembrolizumab therapy.
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TARIS: “Safety and Tolerability of TAR-200 in Subjects With Muscle-Invasive Bladder Cancer Who Are Unfit for Radical Cystectomy”
The purpose of this study is to determine if TAR-200, an investigational drug-delivery system, is safe and tolerable in patients with muscle-invasive bladder cancer (MIBC) who are unfit for radical cystectomy (RC) during an 84-day induction period comprised of four consecutive 21-day dosing cycles.
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CODEX: Study of Inodiftagene Vixteplasmid (BC-819) in Unresponsive Non-muscle Invasive Bladder Cancer (NMIBC)
This study, BC-819-18-204, is a Phase 2, open-label, monotherapy, single-arm, multicenter clinical trial of BC-819 (inodiftagene vixteplasmid) in patients with NMIBC adequately treated with Bacillus Calmette-Guerin (BCG) whose disease is BCG unresponsive. BC-819 is administered directly into the bladder to enable maximal topical exposure to target bladder cancer cells.
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Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)
This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with BCG, compared to BCG monotherapy, in participants with HR NMIBC that is persistent or recurrent following adequate BCG induction.
Expected Management
Canary PASS:
A multicenter, prospective active surveillance study with selective intervention in patients with previously untreated, clinically localized prostate cancer at diagnosis. The objective is to discover and confirm biomarkers that predict aggressive disease.
ProVent: Open- Label Trial of Sipuleucel-T Administered to Active Surveillance Patients for Newly Diagnosed Prostate Cancer
The ProVent study is a randomized, open-label study designed to assess the efficacy of sipuleucel-T in reducing the progression of lower risk non-metastatic prostate cancer compared to subjects followed on active surveillance as standard of care.
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Hormone Therapy (ADT)
Ferring PRONOUNCE: “A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease”
Purpose of this trial is to test if a marketed drug for advanced prostate cancer (FIRMAGON) can reduce the risk of cardiovascular complications as compared to another marketed drug for advanced prostate cancer (LUPRON DEPOT) in patients with prostate cancer and cardiovascular disease. Qualified patients for this study will receive either Firmagon® or Lupron®.
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PROTEUS: A Study of Apalutamide in Participants With High Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
The purpose of this study is to determine if treatment with androgen deprivation therapy (ADT) plus apalutamide (with or without abiraterone acetate with prednisone [AAP]) before and after radical prostatectomy in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS), as compared to ADT plus placebo.
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Study of VERU-944 to Ameliorate Hot Flashes in Men With Advanced Prostate Cancer
A Phase 2 study comparing oral daily dosing of VERU-944 after a week of loading (daily dosing) with placebo to lessen the hot flash symptoms resulting from androgen deprivation therapy in men with advanced prostate cancer.
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Metastatic disease: Cancer that has spread to other areas
Clovis TRITON3: “A Study of Rucaparib Versus Physician’s Choice of Therapy in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency”
The purpose of this study is to determine how patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib versus treatment with physician’s choice of abiraterone acetate, enzalutamide, or docetaxel. Patients will be screened for the deleterious mutation in a BRCA1/2 or ATM gene to qualify.
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MAGNITUDE: A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer
The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate and prednisone (AA-P) compared to AA-P plus placebo.
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QUEST: A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer
This multicenter study will evaluate safety and efficacy of niraparib in combination with other anti-cancer agents.
Stone Disease
Allena ALLN-177: “Evaluate ALLN-177 in Patients With Enteric Hyperoxaluria”
The purpose of this study is to determine the efficacy and safety of ALLN-177 in patients with enteric hyperoxaluria.
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Allena ALLN-177-302: Establishing the Safety and Efficacy of Reloxaliase in Patients With Enteric Hyperoxaluria (URIROX-2)
The purpose of this study is to determine the efficacy, durability and long term safety of reloxaliase in patients with enteric hyperoxaluria.
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Incontinence
Allergan APOLLO: “BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence”
This study will evaluate the efficacy and safety of BOTOX® intravesical instillation in participants with overactive bladder and urinary incontinence.
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CELLEBRATE: Adaptive Design Study of Autologous Muscle Derived Cells Compared to Placebo for Female Urinary Sphincter Repair
This study evaluates the efficacy and safety of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) compared to a placebo in the treatment of stress urinary incontinence (SUI) in adult female patients. Half of the participants will receive AMDC-USR (injections with cells) and the other half will receive a placebo. Participants who are randomly chosen to receive an injection with placebo will have the option to receive an injection with their cells after completion of the blinded portion of their study participation (12 months).
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Renovia -05: Comparing Use of a Digital Health System of Pelvic Floor Exercise Program to Kegel Exercises in Stress Urinary Incontinence
A randomized controlled trial for patients with stress urinary incontinence or stress-dominant mixed incontinence. Subjects will be randomized to 8-weeks of home kegel exercises or 8 weeks of pelvic floor muscle exercises using the leva digital pelvic health system that includes visual biofeedback via smartphone.
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Urethral Stricture
Urotronic ROBUST-II: “Re-establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease”
The study is designed to assess the safety and device performance for the drug coated balloon (DCB) for the treatment of urethral stricture.
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Pelvic Organ Prolapse
No Enrolling Studies at This Time
Hypogonadism
No Enrolling Studies at This Time
Nocturia
No Enrolling Studies at This Time
BPH (Enlarged Prostate)
No Enrolling Studies at This Time
