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