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
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.
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Study of PF-06801591 in Combination with BCG in Participants with Non-muscle Invasive Bladder Cancer (NMIBC)
The study is designed to demonstrate that PF-06801591 plus Bacillus Calmette Guerin (BCG) (induction and maintenance periods) is superior to BCG alone (induction and maintenance periods) in prolonging event free survival (EFS) in participants with high-risk naïve non-muscle invasive bladder cancer (NMIBC) and to demonstrate that PF-06801591 plus BCG (induction period only) is superior to BCG alone (induction and maintenance periods) in prolonging EFS in participants with high-risk NMIBC.
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Convergent Genomics INSITE: Specimen Collection for Validation of UriSeq
Collection of urine and tumor specimens to validate a urine sequencing diagnostic for detection and surveillance of carcinoma of the urinary tract.
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.
Hormone Therapy (ADT)
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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Janssen APA RP: Study of Apalutamide (Adjuvant Treatment) and ADT in Participants Who Have Undergone Radical Prostatectomy for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases
The purpose of this study is to assess if the combination of apalutamide and androgen deprivation therapy (ADT) in participants with high-risk localized prostate cancer improves the biochemical recurrence free rate.
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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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MERCK 991: Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991)
This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus ADT versus placebo plus enzalutamide plus ADT in participants with mHSPC.
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PREVALENCE: A Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer
The purpose of this study is to evaluate the prevalence of 4 or more DNA-repair defects in a population of men with metastatic Prostate Cancer (PC) and to use the variants reported to assess biomarker eligibility for niraparib interventional studies.
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MANA RBM ESCALATE: A Study Comparing Androgen Receptor BlockerWith Radium-223 vs Androgen Receptor Blocker Therapy With Placebo and the Effect Upon Survival for mCRPC Patients
This is a randomized, multi-center, double-blind, Phase III study of radium-223 plus enzalutamide or darolutamide compared to enzalutamide or darolutamide treatment plus placebo.
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Radiation Treatment
Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer (PrTK03)
The purpose of this study is to evaluate the effectiveness of ProstAtak® immunotherapy in combination with radiation therapy for patients with intermediate-high risk localized prostate cancer. ProstAtak kills tumor cells and stimulates a cancer vaccine effect.
Stone Disease
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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Calyxo ASPIRE:Comparison of Laser Lithotripsy With and Without Steerable Ureteroscopic Renal Evacuation (SURE)
The purpose of the study is to compare the effectsof a treatment for removing kidney stones called the SURE procedure for stone evacuation to the standard treatment using a basket for stone removal.The SURE stone evacuation procedure is a technique intended to more easily and completely remove a kidney stone during a laser ureteroscopy surgery.
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Incontinence
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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URO-902 in Female Subjects With Overactive Bladder and Urge Urinary Incontinence
This study will evaluate the efficacy, safety, and tolerability of a single dose of URO-902 24 milligrams (mg) and 48 mg (administered via intradetrusor injection), compared with placebo, in participants with overactive bladder (OAB) and urge urinary incontinence (UUI) up to 48 weeks post-dose.
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Vesair Clinical Trial (VAPOR)
Single-blind, multicenter, randomized clinical trial of the Vesair Balloon in the treatment of Stress Urinary Incontinence in post-menopausal women
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Spinal Singularity FREEDOM: Connected Catheter-Safety and Effectiveness Study
The Connected Catheter is a fully internal, urethral indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization. It is a sterile, extended-use device that resides fully internally to the male lower urinary tract for an intended use life of up to 7 days per catheter.
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Urethral Stricture
No Enrolling Studies at This Time
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)
Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder (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.
