Clinical Trials

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16 studies in Department of Urology

  1. A Phase III Surgical Trial to Evaluate the Benefit of a Standard Versus an Extended Pelvic Lymphadenectomy Performed at Time of Radical Cystectomy for Muscle Invasive Urothelial Cancer

    Rochester, Minn. View Summary

    A Phase III Surgical Trial to Evaluate the Benefit of a Standard Versus an Extended Pelvic Lymphadenectomy Performed at Time of Radical Cystectomy for Muscle Invasive Urothelial Cancer

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    OBJECTIVES: Primary - To compare disease-free survival (DFS) of patients with muscle-invasive urothelial carcinoma of the bladder undergoing radical cystectomy with extended pelvic lymph node dissection (PLND) or standard pelvic lymphadenectomy. Secondary - To compare overall survival (OS) of patients randomized to extended PLND versus those randomized to standard pelvic lymphadenectomy. - To evaluate operative time; whether or not nerve sparing was performed, intraoperative, peri-operative and 90-day morbidity and mortality; length of hospital stay; histology (pure urothelial versus mixed); lymph node counts and lymph node density; adjuvant chemotherapy received; and local and retroperitoneal soft tissue recurrence in patients randomized to extended PLND versus those randomized to standard pelvic lymphadenectomy. - To collect peripheral blood and two paraffin-embedded blocks of the primary tumor for translational medicine studies, including circulating tumor cells (CTCs) and markers of epithelial and mesenchymal transition, and correlate these findings with pathologic T stage and node metastasis as well as DFS and OS. OUTLINE: This is a multicenter study. Patients are stratified according to prior neoadjuvant therapy (yes vs no), clinical stage (T2 vs T3 vs T4a), and Zubrod performance status (0-1 vs 2). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo radical cystectomy and standard pelvic lymphadenectomy. - Arm II: Patients undergo radical cystectomy and extended pelvic lymphadenectomy. Blood and tumor specimens may be collected periodically for translational studies. After completion of study therapy, patients are followed up periodically for 6 years.

    NCT ID:

    NCT01224665

    IRB Number:

    13-003850

    Who can I contact for additional information about this study?

  2. Randomized Control Trial of Silver-alloy Impregnated Suprapubic Catheters in Urogynecology Patients

    Rochester, Minn. View Summary

    Randomized Control Trial of Silver-alloy Impregnated Suprapubic Catheters in Urogynecology Patients

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Urinary catheters are used routinely in the postoperative care of urogynecology patients after surgery involving the genitourinary tract. However, Urinary tract infections(UTI) associated with indwelling catheter is the second leading cause of nosocomial infections. 20% of hospital acquired bacteremia arise from UTI with an associated mortality of 10%. There are many different types of catheters available for use. Standard indwelling catheters are made from a variety of materials including polyvinyl chlorine, plastic, plain latex, polytetrafluoroethylene, silicone elastomer, pure silicone hydrogel and polymer hydromer. Specialized catheters have been developed with the aim of reducing infection. Strategies generally involved coating the inner, outer or both surfaces of the catheter with antimicrobial materials. These materials can be antibiotic or antiseptic with the most common antiseptic material used being silver. Silver ions are bactericidal, are used safely when applied topically to humans and used in controlling infections. Previous studies comparing UTI rates in transurethral catheters have reported a significant reduction of UTI rate in silver-alloy catheters with a range of 5-12% compared to standard catheters with a range of 7-50%. There are no studies comparing the UTI rate in silver-alloy supra-pubic catheters to standard supra-pubic catheters. The investigators hypothesize that this study will show a statistically significant decrease in UTI rate among the individuals with a silver-alloy suprapubic catheter compared to the standard silver-alloy catheter.

    NCT ID:

    NCT01359046

    IRB Number:

    10-007421

    Who can I contact for additional information about this study?

    Rochester: Ruchira Singh, MBBS 507-284-2511
                        


  3. Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of a Single Intraprostatic Treatment of PRX302 for Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (The PLUS 1 Trial)

    Rochester, Minn. View Summary

    Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of a Single Intraprostatic Treatment of PRX302 for Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (The PLUS 1 Trial)

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The purpose of this study is to evaluate the safety and efficacy of a single treatment of PRX302 for the treatment of Benign Prostatic Hyperplasia (BPH) as compared to placebo.

    NCT ID:

    NCT01966614

    IRB Number:

    13-002561

    Who can I contact for additional information about this study?

    Rochester: Jane Smith 507-538-6107
                        


  4. Renal Tumors Classification, Biology, and Banking Study

    Rochester, Minn. View Summary

    Renal Tumors Classification, Biology, and Banking Study

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    PRIMARY OBJECTIVES: I. Classify patients with renal tumors by histological categorization, surgico-pathological stage, presence of metastases, age at diagnosis, tumor weight, and loss of heterozygosity for chromosomes 1p and 16q, to define eligibility for a series of therapeutic studies. II. Maintain a biological samples bank to make specimens available to scientists to evaluate additional potential biological prognostic variables and for the conduct of other research by scientists. SECONDARY OBJECTIVES: I. Monitor outcome for those patients who are not eligible for a subsequent therapeutic study. II. Describe whether the pulmonary tumor burden correlates with outcome in patients with stage IV disease. III. Describe the sensitivity and specificity of abdominal computed tomography (CT) scan by comparing it with surgical and pathologic findings for identification of local tumor spread beyond the renal capsule to adjacent muscle and organs, lymph node involvement at the renal hilum and in the retroperitoneum, preoperative tumor rupture, and metastases to the liver. IV. Compare the sensitivity and specificity of pre-operative abdominal CT scan and MRI for the identification and differentiation of nephrogenic rests and Wilms' tumor in children with multiple renal lesions. V. Correlate the method of conception (natural vs assisted reproductive technology) with the development of Wilms' tumor. OUTLINE: This is a multicenter study. Tumor tissue, blood, and urine samples are collected for research studies, including immunohistochemistry. CT scans and magnetic resonance imaging (MRIs) are also performed. Loss of heterozygosity analyses (chromosome 1p and 16q) are performed by extraction of DNA. DNA polymorphisms are assayed by polymerase chain reaction using standard methodology. Leftover specimens are archived for future studies. Patients are followed periodically for 5 years.

    NCT ID:

    NCT00898365

    IRB Number:

    07-000195

    Who can I contact for additional information about this study?

    Rochester: Carola A. Arndt 507-538-7623
                        


  5. Technical Success, Safety, and Short and Long-term Efficacy for MR-Guided Cryoablation of Prostate Bed Recurrences

    Rochester, Minn. View Summary

    Technical Success, Safety, and Short and Long-term Efficacy for MR-Guided Cryoablation of Prostate Bed Recurrences

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The purpose of this research is to see if MR-guided cryoablation can effectively treat prostate tumor recurrences.

    NCT ID:

    NCT01727284

    IRB Number:

    12-002245

    Who can I contact for additional information about this study?

    Rochester: Connie L. Sathre 507-538-0540
                        


  6. An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)

    Phoenix/Scottsdale, Ariz. View Summary

    An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)

    Location:

    Phoenix/Scottsdale, Ariz.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This is a trial of AGS-003, which is being studied as a possible treatment for Advanced Renal Cell Carcinoma. The purpose of this study is to determine whether there is an overall survival (OS) benefit between subjects treated with AGS-003 in combination with standard treatment versus subjects treated with standard treatment alone.

    NCT ID:

    NCT01582672

    IRB Number:

    13-000333 13-006506

    Who can I contact for additional information about this study?

  7. Randomized Phase II Study Comparing Cabozantinib (NSC #761968) With Commercially Supplied Sunitinib in Patients With Previously Untreated Locally Advanced or Metastatic Renal Cell Carcinoma

    Rochester, Minn. View Summary

    Randomized Phase II Study Comparing Cabozantinib (NSC #761968) With Commercially Supplied Sunitinib in Patients With Previously Untreated Locally Advanced or Metastatic Renal Cell Carcinoma

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    PRIMARY OBJECTIVES: I. To determine if patients with renal cancer treated with cabozantinib (cabozantinib-s-malate) will have improved progression-free survival compared to patients treated with sunitinib (sunitinib malate). SECONDARY OBJECTIVES: I. To determine whether the response rate of patients with renal cancer treated with cabozantinib will be higher when compared with patients treated with sunitinib. II. To determine whether patients with renal cancer treated with cabozantinib will have an improved overall survival when compared with patients treated with sunitinib. TERTIARY OBJECTIVES: I. To determine whether renal cancer patients with high met proto-oncogene (MET) expression by immunohistochemistry (IHC) have improvement in progression-free survival compared to patients with low MET expression on both arms of this study. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive cabozantinib-s-malate orally (PO) once daily (QD) for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 5 years.

    NCT ID:

    NCT01835158

    IRB Number:

    13-004381

    Who can I contact for additional information about this study?

    Rochester: Brian A. Costello 507-538-7623
                        


  8. A Randomized Comparison of Concomitant Incontinence Procedures Performed With Abdominal Sacral Colpopexy: the Burch Versus Mid-urethral Sling Trial

    Rochester, Minn. View Summary

    A Randomized Comparison of Concomitant Incontinence Procedures Performed With Abdominal Sacral Colpopexy: the Burch Versus Mid-urethral Sling Trial

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    I. Specific Aims Pelvic organ prolapse is a common and distressing condition that is frequently associated with stress urinary incontinence (SUI) and often requires surgical repair. Abdominal sacral colpopexy is the preferred operation for repairing pelvic prolapse. As many as 91% of women with pelvic organ prolapse undergoing sacral colpopexy also experience SUI. In addition, up to 44% of previously continent women develop SUI incontinence after sacral colpopexy: perhaps because a sacral colpopexy may predispose to opening of the bladder neck if secured too tightly. The selection of a surgical procedure to prevent and manage SUI in women undergoing sacral colpopexy is empiric rather than evidence-based. Conceptually, a mid-urethral sling may be more effective than a Burch procedure for preventing urinary leakage because a sling provides outlet resistance beyond the bladder neck and therefore it may compensate for a downward tension on the bladder neck resulting from the sacral colpopexy. Indeed, clinical observations suggest that a mid-urethral sling is effective among women who have persistent urinary incontinence after sacral colpopexy with a Burch procedure. Therefore, the investigators' global hypothesis is that a mid-urethral sling is preferable to a Burch procedure for preventing and improving stress urinary incontinence in women undergoing sacral colpopexy for pelvic organ prolapse. The investigators' SPECIFIC AIMS are to evaluate objective and subjective outcomes at 6, 12 and 24 months in 124 women with urinary incontinence and advanced pelvic organ prolapse. All women will be undergoing a sacral colpopexy and will be randomized to either a Burch procedure or a mid-urethral sling. The primary endpoint is composite continence at 6 months while secondary endpoints will include composite continence and subjective measures of incontinence, patient satisfaction and morbidity associated with these procedures. The investigators' hypotheses are as follows: 1. At 6 months, urinary continence rates will be higher after a mid-urethral than after a Burch procedure. Urine continence will be assessed by composite measure of incontinence: no subjective complaint, no interim treatment, and negative standardized stress test performed by a masked observer. This assessment will be repeated at 12 and 24 months post-operatively to establish the medium term continence of the two procedures. Subjective continence and patient satisfaction measures will be obtained at each of the above visits using standardized questionnaires and pelvic organ support will be quantified by Pelvic Organ Prolapse-Quantification (POP-Q) scores. 2. Early events (e.g., blood loss, operative time, intra-operative complications (vascular, bowel and urological injuries), in-hospital complications (need for transfusion, febrile morbidity, thrombotic events, wound infection, length of stay, duration of bladder catheterization and ileus) and delayed postoperative complications (e.g., wound infection, mesh erosion, bowel obstruction and obstructed voiding) will be collected to compare the safety of each procedure.

    NCT ID:

    NCT00934999

    IRB Number:

    07-007334

    Who can I contact for additional information about this study?

  9. A Randomized Phase II Trial of Sunitinib/Gemcitabine or Sunitinib in Advanced Renal Cell Carcinoma With Sarcomatoid Features

    Rochester, Minn. View Summary

    A Randomized Phase II Trial of Sunitinib/Gemcitabine or Sunitinib in Advanced Renal Cell Carcinoma With Sarcomatoid Features

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    OBJECTIVES: Primary - To evaluate the response rate to sunitinib malate with vs without gemcitabine hydrochloride in patients with advanced renal cell carcinoma with sarcomatoid features. Secondary - To evaluate progression-free survival of these patients. - To evaluate overall survival of these patients. - To describe the toxic effects of both sunitinib malate alone and in combination with gemcitabine hydrochloride in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to risk (good risk [clear cell and < 20% sarcomatoid and performance status (PS) 0] vs intermediate risk [20-50% sarcomatoid and PS 0] vs poor risk [non-clear cell or > 50% sarcomatoid or PS 1 or non-clear cell]). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 22, and 29 and oral sunitinib malate once daily on days 1-14 and 22-35. - Arm II: Patients receive oral sunitinib malate once daily on days 1-14 and 22-35. In both arms, courses repeat every 42 days for up to 1 year in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 100 patients (60 in arm I and 40 in arm II) will be accrued to this study.

    NCT ID:

    NCT01164228

    IRB Number:

    10-006075

    Who can I contact for additional information about this study?

    Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                        
    Scottsdale: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                        
    Jacksonville: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                        
  10. An Open, Non-interventional, Retrospective, Comparative, Multicenter Follow-up Study in Patients Included in the Previously Completed Clinical Study pc b305/04, to Assess a Longer-term Recurrence Rates in Patients After Hexvix® (Cysview®)Fluorescence Cystoscopy/Turb or White Light Cystoscopy/TURB

    Rochester, Minn. View Summary

    An Open, Non-interventional, Retrospective, Comparative, Multicenter Follow-up Study in Patients Included in the Previously Completed Clinical Study pc b305/04, to Assess a Longer-term Recurrence Rates in Patients After Hexvix® (Cysview®)Fluorescence Cystoscopy/Turb or White Light Cystoscopy/TURB

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    A previously completed pivotal clinical study PC B305/04 demonstrated reduced recurrence rates for patients with papillary bladder cancer who underwent Hexvix (Cysview) and white light cystoscopy and transurethral resection (TURB) of the bladder compared to patients who underwent white light cystoscopy and TURB alone. The present study is intended to investigate whether the improved initial detection and resection of bladder cancer lesions in patients with non-muscle invasive bladder cancer with Hexvix (Cysview) fluorescence cystoscopy/TURB will also lead to a longer-term reduction in recurrences compared to standard white light cystoscopy/TURB.

    NCT ID:

    NCT01166230

    Who can I contact for additional information about this study?

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