Clinical Research

The Clinical Research Department of Regional Urology sets us apart from many urology practices. We participate in numerous clinical research projects with the major pharmaceutical companies both across the country and internationally. This research helps bring new medication to the market for use in the future. We also have been able to offer new forms of therapy to our patients that are not available.

When our patients participate in the clinical trials at Regional Urology, it gives them the opportunity to have medications and procedures that are unavailable to the general public. Patients receive test and study medications at no cost. Participation is always voluntary.

The research department at Regional Urology, LLC perform studies in the following areas:

  • Overactive Bladder Symptoms
  • Stress Incontinence
  • Urge Incontinence
  • BPH
  • Erectile Dysfunction
  • Low Testosterone
  • Prostate Cancer
  • Bladder Cancer

Study for Patients with Secondary Hyperoxaluria with Kidney Stones

The purpose of this study is to learn more about the effect of an investigational drug called ALLN-177. It is designed to break down oxalate when taken with food. Oxlate is an organic chemical that occurs naturally in many foods. Leafy plants such as spinach and rhubarb contain large amounts of oxalate. Oxalate is removed from the body by the kidneys and passed into the urine. Some people have too much oxalate in the urine, and this can cause kidney stones and other health problems.

If ALLN-177 is successful in breaking down oxalate in foods in the gut and decreasing the amount of oxalate absorbed, it may help treat these medical conditions. The study will enroll male and female patients 18 years or older who have a history of hyperoxaluria. The study will be conducted at approximately 12 to 18 research centers in the United States.

Non-Invasive Bladder Cancer Study

The purpose of this study is to gather information on the safety and effectiveness of the study drug, which is an investigational drug called apaziquone.

Apaziquone is an investigational, anti-cancer drug known as a bio-reductive alkylating indoloquinone which is thought to cause cell death. Early studies in humans have shown apaziquone has some anti-cancer activity that may prevent or delay the return of bladder cancer following surgery. It has been given to approximately 1314 people with bladder cancer in other research studies.

The standard of care for bladder tumors is to surgically remove the tumors via surgery (TURBT). The study is to determine if giving apaziquone right after the surgery will decrease the risk of the cancer coming back. Approximately 1869 people will be enrolled in this study. This study will take place in approximately 100 hospitals/institutions.

Newly Diagnosed Prostate Cancer Study

The main purpose of this study is to see if JNJ-56021927 plus androgen deprivation therapy (ADT), also known as hormone therapy, improves treatment with radiation therapy. About 1500 patients at least 18 years of age will take part in this study worldwide. JNJ-56021927 is a type of drug that blocks the action of testosterone. By doing so it may slow down or stop the growth of prostate cancer cells.

Metastatic Castration-resistant Prostate Cancer Study

The purpose of this study is to compare the time it takes for tumors to grow based on radiological studies in patients who receive galeterone compared to a standard treatment, enzalutamide, which is approved in the US. This study will also compare other effects between the two drugs such as quality of life, degree of pain, the time it takes before starting another cancer therapy, decreases in PSA and evaluation of tumor shrinkage. In clinical studies, galeterone has shown reductions in PSA and the tumor in men with castration-resistant prostate cancer study.

High-risk localized and locally advanced prostate cancer patients planning to undergo radiation therapy.

The purpose of this study is to determine if JNJ-56021927 plus androgen therapy (ADT), also known as hormone therapy, improves treatment with radiation therapy (RT). JNJ-56021927 is a novel type of drug that blocks the action of testosterone. By doing so, it can slow down or stop the growth of prostate cancer cells.

Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) Study

The purpose of this study is to investigate the safety and effectiveness of LiRIS 400 mg in the potential treatment of IC/BPS. The investigational product is pretzel shaped and is made of silicone and contains a wire to maintain the pretzel shape in the bladder.

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