A clinical trial is a research study that finds new ways to treat a disease. The Arkansas Urology Research Center (AURC) participates in several clinical research trials to offer therapies to our patients that are not yet available at other local practices or clinics in Arkansas. These clinical trials are available to men and women of all ages.
You’ll find a few studies that we are actively enrolling our patients in listed below. We have additional studies not listed. Please contact the AURC at 501-219-8900 x2002 if you are interested in learning more about these studies and/or other research opportunities.
Prostate Cancer
*Semen Collection – GREGOR DIAGNOSTICS
The purpose of this study is to evaluate tumor markers from semen to screen for and determine the aggressiveness of prostate cancer.
Patients may be eligible to participate if:
Men 50 years of age or older
Men scheduled to have a prostate biopsy
Men on active surveillance are encouraged to participate
The following patients are ineligible to participate:
Men who have undergone prostate cancer treatments
Men who have been diagnosed with another cancer EXCEPT for skin cancer
How it works: A semen sample is collected prior to prostate biopsy and brought to clinic within 3 hours .
*Blood Collection – Immunis AI
The purpose of this research is to see if a new, experimental blood test might help men with prostate cancer who are on active surveillance need fewer prostate needle biopsies.
Patients may be eligible to participate if:
Men between 40-80 years of age
Men on active surveillance scheduled to have a prostate biopsy
How it works: A blood sample is collected in Little Rock at the lab or at the surgery center prior to your biopsy.
MVT-601-049
Myovant Sciences is conducting a clinical study to learn about the safety and tolerability of relugolix in combination with medications approved for use in combination with androgen-deprivation therapy (ADT) for the treatment of patients with metastatic castrate-sensitive prostate cancer (mCSPC), non-metastatic castrate-resistant prostate cancer (nmCRPC) and metastatic castrate-resistant prostate cancer (mCRPC).
Relugolix is an oral, FDA-approved medication. The clinical study will have two parts. Patients with advanced prostate cancer will participate in only one of the two parts of the clinical study.
Part 1: Relugolix in combination with abiraterone acetate and a corticosteroid Part 2: Relugolix in combination with apalutamide
Patients currently being treated with leuprolide acetate (Lupron® or Eligard®) or degarelix (Firmagon®) in combination with abiraterone acetate (Zytiga®)/fine-particle abiraterone acetate (Yonsa®), apalutamide (Erleada®) may be eligible to participate. Additional eligibility criteria will apply.
Myovant Sciences is conducting a prospective observational study of patients being treated with ORGOVYX. The goal of this study is to generate real-world evidence about the safety and effectiveness of ORGOVYX in patients with prostate cancer in routine clinical care and the clinical course during treatment with and following cessation of ORGOVYX.
Patients who are initiating treatment or have initiated treatment with ORGOVYX within the 1 month prior to the time of study enrollment and who remain on treatment at the time of enrollment are eligible. The decision to initiate treatment with ORGOVYX should be made prior to study enrollment. The study is designed to better understand the actual experience of patients with prostate cancer treated with ORGOVYX by collecting data on treatment patterns, adherence, and selective safety data. Additionally, a better understanding of the trajectory of patients with prostate cancer following cessation of ORGOVYX therapy will be gained by observing the clinical course of the disease, health outcomes, and health-related quality-of-life (HRQoL) in these patients.
Janssen is conducting a Phase 2, Open-Label, Multi-Center, Randomized Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Scheduled for Radical Cystectomy and Are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy.
The TAR-200/ gemcitabine (JNJ-17000139) product is an intravesical drug delivery system regulated as an investigational drug. The drug constituent consists of gemcitabine minitablets and osmotic minitablets. Cetrelimab (JNJ-63723283) is a fully human immunoglobulin G4 (IgG4) kappa monoclonal antibody (mAb) that binds programmed-cell death protein (PD)-1. The standard of care in MIBC includes radical cystectomy (RC) with urinary diversion and is considered the preferred treatment option for participants who are considered surgical candidates. Study consists of a Screening phase, Treatment phase and follow-up phase. The total duration of study will be up to 2 years and 6 months. Efficacy, safety, pharmacokinetics (PK), and biomarkers will be assessed at specific time points during this study.
Janssen is conducting a Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy and Safety of TAR-200 in Combination with Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants with BCG-naïve High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC)
Enlarged Prostate/BPH
iTind
iTind is a clinically-proven treatment that relieves lower urinary tract symptoms due to an enlarged prostate, or BPH. The iTind procedure reshapes the anatomy of the prostatic urethra, gently creating a wider opening for urine to flow freely, without burning or cutting out tissue, and without leaving behind a permanent implant. The treatment is straightforward, does not require overnight hospitalization, and has none of the side effects associated with prescription medication.
The iTind treatment is a simple procedure performed by a urologist. The device is placed in the prostatic urethra in a folded configuration. During the 5 to 7-day treatment, it slowly expands and exerts gentle pressure at three precise points to widen the opening through which urine flows through the prostatic urethra and then out of the body. After 5 to 7 days, the device is completely removed. Clinical trials demonstrate that the newly remodeled prostatic urethra will continue to provide long-lasting relief of BPH symptoms.
To learn more about this study please visit: itind.com
Kidney Stones
The AEROLITH Clinical Study will evaluate the safety and effectiveness of Applaud Acoustic Enhancer when used in conjunction with conventional ureteroscope laser lithotripsy (URS-LL) in the treatment of subjects with urinary stones. The Acoustic Enhancer is a micro bubble consisting of a gas core with a lipid shell and is designed to produce rapid, large‐amplitude expansions and contractions, then a final collapse. This collapse near a hard surface triggers inertial cavitation, which causes erosion and fragmentation of the stone. The lipid shell is very similar in structure and composition to the cellular membrane in human cells and has been accepted by the FDA as a low-risk biocompatible device for use in the urinary system within Applaud’s current clinical trial. The result is faster fragmentation, fewer and smaller fragments and better outcomes.
