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Areas of Urology and Research
Patient Information
Articles A very helpful explanation of informed decision-making that is necessary when discussing and making a decision for PSA screening/early detection PSA Testing - Best Practices Statement Views from the Other Side - Personal Reflections about Prostate Cancer Expressed Prostate Secretions Biomarker NIH Grant Awarded PSA Testing - Evaluation and Considerations My Side - A Personal Encounter with Prostate Cancer Calcium Supplementation and Vitamin D Therapy REDUCE Trial - Reduction by Dutasteride(Avodart) of Prostate Cancer PROVENGE Trial a Success For Your Sons - Promoting Awareness Within the Family Cardiometabolic Disorders: Do They Matter? Testosterone & Prostate CA: How Low is Low? Clinical Trials Please contact laurie jackson at (757) 452-3461 for additional information Enrolling Bladder Cancer Studies at Urology of Virginia Spectrum Pharmaceuticals SPI-1011 “A Phase 3 International, Multicenter, Double-Blind, Placebo-Controlled, Randomized Trial Evaluating the Efficacy and Safety of Multiple Instillations of Intravesical Apaziquone vs. Placebo in Patients with Low-Intermediate Risk Non-Muscle Invasive Bladder”
This study is designed for patients who have transitional cell carcinoma and will undergo a resection of the bladder tumor. All subjects will receive a single instillation of apaziquone in the bladder after the resection. After pathology review, some subjects randomize to a maintenance regimen. These subjects will receive 6 weekly intravesical instillations of either apaziquone or placebo. All subjects will be followed for two years with periodic cystoscopies to check for recurrence of tumors. The recurrence rate between the two treatment groups will be compared.
Dendreon N10-1, “A Randomized, Phase 2, Open-label Study Evaluating DN24-02 as Adjuvant Therapy in Subjects with High Risk HER2+ Urothelial Carcinoma”
DN24-02 is an autologous cellular immunotherapy product designed to simulate an immune response against HER2/neu. This study has been designed as there are few treatment options available to patients with HER2+ urothelial cancer following surgery. The primary study objective is overall survival following administration of the DN24-02.
Enrolling Prostate Cancer Studies at Urology of Virginia
Hormone Therapy:
GTx, Inc. G200710, “Phase II, Open-label, Loading and Maintenance Dose Finding Study of GTx-758 in Men with Prostate Cancer”
GTx-758 is a nonsteroidal selective ERα agonist (SERM). As a result, this compound may also maintain bone, reduce the incidence of hot flashes, and positively affect the adverse lipid changes that are commonly associated with LHRH agonist and antagonists. This study is intended for men for which ADT is indicated. All subjects will receive study drug in this 4 arm study.
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GP-Pharm GP/C/05/PRO, “Efficacy and Safety of a New Leuprolide Acetate 22.5 mg Depot Formulation in the Treatment of Prostate Cancer”
This study is intended for men requiring hormone therapy. The primary objective is to determine the proportion of men achieving chemical castration at specific timepoints throughout the study. All patients will receive study drug, 2 doses 3 months apart for a total of 6 months.
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Endo Pharmaceuticals, Implant Explant Registry-VANTAS
This is an observational study for men being treated for CaP with the Vantas implant. Data will be collected regarding the procedures undertaken during implant and explant visits.
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Hormone Refractory OR Metastatic disease:
Millennium Pharmaceuticals, Inc. “A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients with Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer”
This study is intended for patients who no longer respond to hormone therapy and whose cancer has spread to the bone or soft tissue. Patients will receive prednisone with either TAK-700 or placebo. TAK-700 is a tablet administered orally on a twice daily schedule. Patients eligible for this trial cannot have already undergone chemotherapy. The purpose of this study is to determine if TAK-700 with prednisone improves radiographic progression free survival and overall survival status.
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Astellas Pharma MDV3100 “A Randomized, Double-Blind, Phase II, Efficacy and Safety Study of MDV3100 (ASP9785) vs. Bicalutamide in Castrate Men with Metastatic Prostate Cancer”
This study is intended for patients who no longer respond to hormone therapy and whose cancer has spread to the bone or soft tissue. Patients will receive either MDV3100 or bicalutamide (Casodex). Both drugs are administered orally and patients will not know which compound they are receiving. Patients eligible for this trial cannot have already undergone chemotherapy. The purpose of this study is to determine the progression free survival in patients treated with MDV3100 as compared to those treated with bicalutamide.
GTx, Inc. G200707, “Open Label Study of the Effect of GTx-758 on Serum PSA and Free Testosterone Levels in Men with Castration Resistant Prostate Cancer and Maintained on Androgen Deprivation Therapy”
GTx-758 is a nonsteroidal selective ERα agonist (SERM). As a result, this compound may also maintain bone, reduce the incidence of hot flashes, and positively affect the adverse lipid changes that are commonly associated with LHRH agonist and antagonists. This study is intended for patients who no longer respond to hormone therapy, and whose cancer may or may not have spread to the bones or soft tissue. The study will assess the effect of GTx-758 on PSA and testosterone levels. This is an oral tablet and all subjects will receive study drug.
Dendreon P11-3, “A Randomized, Open-label, Phase 2 Trial of Sipuleucel-T with Concurrent Versus Sequential Administration of Abiraterone Acetate Plus Prednisone in Men with Metastatic Castrate Resistant Prostate Cancer”
This study is intended for patients who no longer respond to hormone therapy and whose cancer has spread to the bone or soft tissue. All qualified subjects will receive Provenge (sipuleucel-T) and Zytiga (abiraterone acetate) and prednisone. Some will receive Zytiga along with the Provenge, while others will receive Provenge followed by Zytiga. All subjects will undergo leukapheresis followed by infusion of the Provenge product with their own cells. Zytiga and prednisone are oral pills taken daily. Provenge is infused 3 times over a 6 week period, and Zytiga is a 26 week course of treatment.
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Dendreon P10-3, “A Registry of Sipuleucel-T Therapy in Men with Advanced Prostate Cancer”
This is an observational study for men being treated with Provenge for CaP. Data will be collected regarding the normal course of clinical practice.
Enrolling Kidney Cancer Studies at Urology of Virginia
GlaxoSmithKline “A Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Pazopanib as Adjuvant Therapy For Subjects With Localized or Locally Advanced RCC Following Nephrectomy”
For patients with localized or locally advanced renal cell carcinoma, and who are at high risk to develop recurrence and metastasis. Patients will receive either pazopanib (Votrient) or placebo daily for 12 months. The pazopanib or placebo is a tablet and will be taken daily. Qualified patients who have either had, or will undergo a nephrectomy are eligible. Study participants will receive extensive follow up with scans and visits during the course of the study. The study will measure disease-free survival.
Enrolling Urologic Studies at Urology of Virginia
Stone Disease
Watson Silodosin “A Double-Blind, Placebo-Controlled Study of Silodosin to Facilitate Urinary Stone Passage”
This study is designed for patients who are diagnosed with renal colic due to a kidney stone in the ureter. Eligible patients will receive either silodosin (Rapaflo) capsule or a placebo capsule, taken once daily for up to 4 weeks. The objective of this study is to evaluate the efficacy of silodosin in increasing the incidence rate of spontaneous stone passage.
Incontinence
No current enrolling studies.
Nocturia
No current enrolling studies.
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