Research

Clinical Trials

Clinical patientClinical trials strive to find solutions to some of life’s most complex conditions, diseases, and disorders. They are modern medicine’s answer to the questions “why?” and “how?”

Through clinical trials, we find out whether a new treatment works and is safe. For many, they provide hope and promise for an improved quality of life. They are carefully designed research studies that answer specific questions about the effectiveness of preventive techniques, medications, therapies and treatments and surgical techniques.

About the Center for Clinical Trials

The Department of Urology’s Center for Clinical Trials is a clinical research center that helps facilitate innovative new products and medications for the research community and patients by conducting Phase II – IV clinical trials. Phase II trials have been proven safe for humans, while Phase III and IV trials are designed for large groups and to test drug efficacy and safety after they’re on the market.

Participation in a clinical trial does not substitute for regular medical care. Discuss participation in clinical trials with your physician. For more information about current clinical trials, or the clinical trial process at the University of Minnesota, contact Therese Perrier at perri084@umn.edu or 612-625-3319.

Current Trials

Click the tabs below to view details on clinical trials within the Department of Urology. Contact the researcher listed within each trial for more information.

Bladder Cancer

Bladder Cancer

1. Comparison of Open vs. Robotic Cystectomy

Dr. Badrinath Konety

Study designed to evaluate and compare the outcomes immediately following and in the long term after either a robotic or open cystectomy.  This is the first trial of its kind.  The researchers hope to gain a better understanding of which type of surgery may be more beneficial.

Inclusion Criteria:

  • Patient must have biopsy proven bladder cancer
  • Patient must be undergoing a cystectomy and be eligible for robotic cystectomy

2. A Randomized, Phase II, Study Evaluating DN24-02 as Adjuvant Therapy in Subjects with High Risk Urothelial Cancer

Dr. Badrinath Konety

DN24-02 is a cellular immunotherapy product designed to stimulate an immune response against the human proto-oncogene HER2/neu.  Approximately 50% of patients with urothelial cancer overexpress the HER2/neu oncogene.  The primary study objective is to evaluate the overall survival of patients following administration of DN24-02 compared to those who do not receive the product.

Inclusion Criteria:

  • Surgical resection of high risk urothelial carcinoma with lymph node dissection
  • High risk carcinoma defined as tumor stage pT2 or N+ disease or greater
  • No evidence of residual disease or metastasis following resection
  • HER2/neu tissue expression by immunochemistry

3. Apaziquone vs. Placebo in Patients with Non-Muscle Invasive Bladder Cancer

Dr. Badrinath Konety

The study is designed to evaluate the safety and efficacy of intravesical induction therapy with the chemotherapy agent Apaziquone.  There are not a lot of treatment options for patients with low-intermediate risk bladder cancer.  The hope is that Apaziquone, administered following a TURBT and an additional 6 times after the resection, will prove to be safe and effective option for patients.  The primary goal of the study is to compare the time to tumor recurrence between patients who were given Apaziquone and patients given a placebo.

Inclusion Criteria:

  • Clinically apparent primary or recurrent low grade Ta non-muscle invasive bladder cancer with multiple (2-7) tumors OR clinically apparent primary or recurrent high grade Ta NMIBC with a single tumor (>3 cm)
  • Patient must be able to retain bladder instillations for 1 hour
  • For patients with recurrent tumor, the patient must have at least a 6-month cystoscopically-confirmed tumor-free interval between the last tumor recurrence and the time of screening

4. A Randomized Double-Blind Phase III Study Comparing Gemcitabine,Cisplatin and Bevacizumab to Gemcitabine Cisplatin and Placebo in Patients with Advanced Transitional Cell carcinoma

Dr. Bruce Peterson

This randomized phase III trial is studying gemcitabine hydrochloride, cisplatin, and bevacizumab to see how well they work compared with gemcitabine hydrochloride, cisplatin, and placebo in treating patients with advanced urinary tract cancer.

Inclusion Criteria:

  • Histologically or cytologically confirmed transitional (urothelial) cell carcinoma of the urinary tract
  • Unresectable or progressive metastatic or locally advanced disease

Prostate Cancer

Prostate Cancer

1. A Randomized, Phase II, Study of MDV 3100 vs. Bicalutamide in Patients with Hormone Refractory Metastatic Prostate Cancer

Dr. Chris Warlick

MDV 3100 is a novel androgen receptor antagonist that has been shown in preclinical studies to be more effective at suppressing the androgen receptor pathway than Bicalutamide.  This study is designed to determine the safety and efficacy of MDV 3100 vs. Bicalutamide.  Prostate cancer patients who reach this stage of the disease do not have a lot of effective treatment options.  MDV 3100 could provide another treatment modality for these patients.

Inclusion Criteria:

  • Hormone Refractory Metastatic Prostate Cancer
  • Estimated life expectancy of >12 months
  • No known or suspected brain or skull metastasis are allowed

2. Detection of Circulating Prostate Cancer Genetic Material from Prostate Cancer Patients by RT-PCR for the Androgen Receptor

Dr. Chris Warlick

Many prostate cancer patients carry a genetic variation in the androgen receptor that helps regulate normal development and maintenance of the prostate.  The goal of this study is to evaluate these genetic defects in patients at many stages of the disease.  Potentially this data could lead to a more effective way of recognizing which patients have an aggressive form of the disease.

Inclusion Criteria:

  • Prostate Cancer
  • Willingness to give blood

3. Assessment of 3D Virtual Reality BPH and TURP Model for Patient Education and Informed Consent

Dr. Rob Sweet

Often it can be hard to convey to patients how BPH causes its side effects and how treatment can alleviate those side effects.  Dr. Sweet and the university have developed a 3D virtual reality model to help patients understand their disease and treatment.  This study is designed to analyze how patients respond to the new model and if it is beneficial for them. 

Inclusion Criteria:

  • Men > 45
  • AUA Symptom score >9, obstructive component >6, or peak urine flow <15 mL/sec

4. Active Surveillance for Men with Low Volume, Early Stage, Screen Detected Prostate Cancer

Dr. Chris Warlick

Occasionally prostate cancer patients will be treated aggressively when a more conservative approach would be more prudent.  Men with low volume, early stage cancer can be monitored using biomarkers and MRI screening to avoid unnecessary treatment.  The goal of this study is to evaluate the clinical outcomes of these patients throughout the course of their disease.

Inclusion Criteria - Newly diagnosed, untreated prostate cancer that meets the following criteria:

  • Un-palpable
  • PSA Density (PSA marker divided by prostate volume) < 0.15
  • Favorable characteristics on biopsy

5. NaDiA ProsVue Field Experience Trial

Dr. Chris Warlick

NADiA ProsVue is an FDA-cleared in-vitro diagnostic assay that is able to detect very low levels of the prostate specific antigen.  This test could be invaluable in determining early which patients may have a recurrence after a radical prostatectomy.  The study aims to evaluate the usefulness of the test to physicians and gain physician feedback on their experience.

Inclusion Criteria:

  • Males treated with a radical prostatectomy within the last 15 months
  • Patients have a legitimate risk factor for recurrence

6. Acticuf Use in Men Following Radical Prostatectomy

Dr. Sean Elliot

Acticuf is a new device for managing incontinence after radical prostatectomy. Interested men are randomized to using incontinence pads for three days then the Acticuf or the Acticuf first then the incontinence pads. At the end of the week men submit answers to a questionnaire about their preferred treatment method.

Inclusion Criteria:

  • Patients with incontinence following radical prostatectomy

7. Phase II Trial of Single High Dose Cholcalciferol and Daily Genistein vs. Placebo in Men Undergoing Prostatectomy

Dr. Badrinath Konety

There are specific groups of patients who are at high risk of being diagnosed with prostate cancer and may benefit from chemopreventive agents as a primary cancer prevention strategy.  There is also a role for secondary prevention of prostate cancer in patients who have been treated for localized prostate cancer and are at risk for tumor recurrence.  The study proposes to assess the effect of genistein (a soy based product) and cholecalciferol (vitamin D) on the modulation of vitamin D3-related biomarkers in patients undergoing radical prostatectomy for localized prostate cancer as compared to placebo.

Inclusion Criteria:

  • Patients with prostate cancer confined to the prostate, who are also candidates for prostatectomy
  • Patients may not have received any prior therapy for prostate cancer

8. A Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy VS Immediate Radical Prostatectomy in Patients with High-Risk Clinically Localized Prostate cancer

Dr. Bruce Peterson

The objective of the study is to compare the rate of 3-year biochemical progression-free survival (bPFS) in patients with high-risk, clinically localized prostate cancer treated with radical prostatectomy with vs without neoadjuvant chemohormonal therapy with docetaxel and androgen-deprivation therapy with leuprolide acetate or goserelin.

Inclusion Criteria:

  • Patients must have histologically confirmed adenocarcinoma of the prostate, T1-3a

9. A Randomized Double-Blind Phase III Study Comparing Gemcitabine,Cisplatin and Bevacizumab to Gemcitabine Cisplatin and Placebo in Patients with Advanced Transitional Cell carcinoma

Dr. Bruce Peterson

This randomized phase III trial is studying gemcitabine hydrochloride, cisplatin, and bevacizumab to see how well they work compared with gemcitabine hydrochloride, cisplatin, and placebo in treating patients with advanced urinary tract cancer.

Inclusion Criteria:

  • Histologically or cytologically confirmed transitional (urothelial) cell carcinoma of the urinary tract
  • Unresectable or progressive metastatic or locally advanced disease

Kidney Cancer

Kidney Cancer

1. Treatment for Very Low and Standard Risk Favorable Histology Wilms Tumor

Dr. Emily Lipsitz

This phase III trial is studying vincristine and dactinomycin with or without doxorubicin and radiation therapy or observation only to see how well they work in treating patients undergoing surgery for newly diagnosed stage I, stage II, or stage III Wilms' tumor.

Inclusion Criteria: Patients must have histologically confirmed Wilms' tumor - newly diagnosed stage I-III disease and have favorable histology.

2. Renal Tumors Classification, Biology and Banking Study.

Dr. Emily Lipsitz

Tumor tissue, blood, and urine samples are collected for research studies, including immunohistochemistry. CT scans and 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 10 years.

Inclusion Criteria: Must have a diagnosis of a renal tumor, including nephroblastic tumors, mesoblastic nephroma, clear cell sarcoma, rhabdoid tumor, renal epithelioid tumors of childhood, angiolipoma or ossifying renal tumor of infancy.

3. Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors

Dr. Emily Lipsitz

This phase III trial is studying how well combination chemotherapy with or without radiation therapy works in treating young patients with newly diagnosed stage III or stage IV Wilms' tumor.

Inclusion Criteria: Patients must have newly diagnosed Wilms' tumor (Stage III or IV) and previously enrolled in biological study

4. An open-label, randomized, multi-center, Phase III study to compare the safety and efficacy of TKI258 versus sorafenib in patients with metastatic renal cell carcinoma after failure of anti-angiogenic (VEGF-targeted and mTOR inhibitor) therapies

Dr. Arkadiusz Dudek

This study will evaluate the safety and efficacy of TKI258 (Dovitinib) versus sorafenib in patients with metastatic renal cell cancer

Inclusion Criteria: Patients with metastatic renal cell carcinoma (mRCC) with histological or cytological confirmation of clear cell carcinoma or a component of clear cell.

Interstitial Cystitis

Interstitial Cystitis

Proteomic Identification of Urinary Biomarkers for Interstitial Cystitis

Dr. Nissrine Nakib

Interstitial Cystitis is a disease syndrome in which there is no direct diagnosis and no effective treatment.  The goal of this study is to identify biomarkers from patients with IC in order to help develop a better diagnostic tool, an effective treatment, or both.

Inclusion Criteria:

  • Women age 18 or older
  • Meet the criteria of one of these groups: urinary urgency, frequency (not IC, used for comparison); urinary urgency, frequency and pelvic pain (pain of 3/10 on a pain scale); urinary urgency, frequency, pelvic pain, and petechiae/granulations

Neurogenic Bladder

Neurogenic Bladder

Patient Reported Outcomes for Bladder Management in Spinal Cord Injuries

Dr. Sean Elliott

Survey based study examining quality of life in patients with both a diagnosis of Neurogenic Bladder (NGB) and a Spinal Cord Injury (SCI)

Inclusion criteria:

  • 18 years of age or older 
  • Have a recent or past spinal cord injury 
  • Be willing to participate in a 15 minute enrollment interview 
  • Commit to completing questionnaires about their health and quality of life related to their bladder management and spinal cord injury every three months for one year

Research ethics at the University of Minnesota

We are committed to protecting research participants, upholding ethical standards, and improving our practice at every step of our work.

 Learn more about our commitment to research ethics