Clinical Trials

Clinical trials are carefully designed research studies that answer specific questions about the safety and effectiveness of preventive techniques, medications, treatments, therapies or surgical techniques. Participation in a clinical trial is strictly voluntary.

Many studies that are developed and available are similar to treatments often referred to as the “gold standard.” Advancements in medicine may lead to improved outcomes through improved results, less discomfort, less time involved in treatment, lower cost, and/or improved safety. At Urology Associates, we are very selective about studies that we choose to offer to our patients. Please read further to see what is currently offered and contact our office with any questions.

Urology Associates is enrolling patients for clinical trials for benign prostatic hyperplasia (BPH), urologic cancersstress incontinence, among others, in order to help our patients live longer, healthier lives.

Am I eligible?

Many studies have strict enrollment criteria. The list of inclusion and exclusion criteria are different for each study. Our office can easily assess whether a patient is eligible for a particular study.

Deciding whether or not to participate in a urology clinical trial is a very important choice that should be carefully considered and thoroughly discussed between a patient and his or her doctor.

For more information about whether a patient is eligible for our studies, please visit clinicaltrials.gov or Contact Us Online

Bladder cancer

CONQUER – bladder cancer study

The purpose of this study is to evaluate the Time to Recurrence in patients with low- to intermediate-risk non-muscle invasive bladder cancer (NMIBC) who receive either 8 mg Qapzola or placebo post transurethral resection of bladder tumor (TURBT).


Eligibility Criteria
Major inclusion criteria
  • Patient has diagnosis of low to intermediate risk NMIBC
  • Patient is at least 18 years of age and <90 years of age
Major exclusion criteria
  • Patient has high risk NMIBC or bladder cancer that is muscle invasive or positive for metastasis
  • Patient has received any previous intravesical therapy for bladder cancer – chemotherapy, immunotherapy (NO BCG!)
  • Patient has any unstable or uncontrolled medical condition that would make it unsafe to undergo a TURBT

QUILT Study – bladder cancer study

The purpose of this study is to assess the antitumor activity of intravesical BCG in combination with ALT-803 immunotherapy protein complex in patients with BCG unresponsive high-grade NMIBC as determined by the disease response rating using cystoscopy, bladder biopsy and urine cytology.
Eligibility Criteria
Major inclusion criteria
  • Male or female patients 18 years of age or older
  • Histologic confirmation of NMIBC of the transitional cell carcinoma high-grade subtype
  • BCG unresponsive disease as defined as persistent high grade disease or recurrence within 6 months of receiving at least 2 courses of BCG (1 induction course and 1 maintenance course)
Major exclusion criteria
  • Recurrence > 6 months after last BCG instillation
  • Evidence of muscle-invasion or regional and/or distant metastatic bladder cancer
  • Symptomatic CHF, severe/unstable angina pectoris, or myocardial infarction within 6 months prior to study entry

Overactive bladder

Bioness StimRouter study – overactive bladder (OAB)

The purpose of this study is to assess the safety and efficacy of the StimRouter stimulation therapy in improving overactive bladder (OAB) symptoms when targeting the posterior tibial nerve.
Eligibility Criteria
Major inclusion criteria
  • Male or female age 22 years or more
  • Average urinary frequency of ≥10 daily voids with urgency
  • Able to toilet self and maintain good personal hygiene
  • Patient must have a body mass index (BMI) of less than or equal to 30
  • Willing to discontinue any tricyclic antidepressant
Major exclusion criteria
  • Treated with Botox or surgery in past 12 months
  • Current or prior use of PTNS, SNS, pelvic floor muscle stimulation or biofeedback
 

Detrusor overactivity

Gelnique – pediatric detrusor overactivity study

The purpose of this study is to evaluate the efficacy of daily treatment with oxybutynin chloride gel in pediatric patients with detrusor overactivity associated with a neurological condition who are using clean intermittent catheterization (CIC).
Eligibility Criteria
Major inclusion criteria
  • Patient age 3 ­– 16 years
  • Diagnosed with detrusor overactivity associated with a neurological condition
  • Must be using CIC
Major exclusion criteria
  • Patient-reported CIC use higher than 6 times within 24 hours
  • Urinary tract anatomical abnormalities
  • Have had surgical bladder augmentation within 1 year of study screening

Prostate cancer

EMBARK Study – High Risk Nonmetastatic Prostate Cancer

The purpose of this study is to examine treatment with Enzalutamide plus Leuprolide, Enzalutamide monotherapy, and placebo plus Leuprolide in men with high-risk nonmetastatic prostate cancer that has progressed after radical prostatectomy or radiotherapy or both.

Eligibility Criteria
Major inclusion criteria
  • Male 18 years or older with histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy without neuroendocrine differentiation, signet cell, or small cell features
  • Prostate cancer initially treated by radical prostatectomy or radio therapy or both with curative intent
  • PSA doubling time < 9 months and serum testosterone > 150ng/dL at screening
Major exclusion criteria
  • Prior or present evidence of metastatic disease by CT, MRI, chest x-ray and whole body bone scan
  • Prior hormonal therapy or prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiaterone acetate, or Enzalutamide therapy

TRUMPET study – Astellas metastatic castration-resistant prostate cancer (CRPC) registry

Collection of data from patients with metastatic castration-resistant prostate cancer (mCRPC) who are receiving their first approved, active course of anti-cancer treatment.

Eligibility Criteria
Major inclusion criteria
  • Male patient age > 18 years
  • Confirmed diagnosis of CRPC, as defined by a minimum of two rising PSA levels measured at least 7 days apart, and serum testosterone level <73 nmol/L (50 ng/dL), or with new evidence of metastatic disease by investigating physician
  • Initiating first active course of anti-cancer treatment for M0 CRPC or for M1 CRPC (regardless of prior M0 CRPC treatment) such as anti-androgens, androgen synthesis inhibitors, chemotherapy, immunotherapy or radionuclide therapy. Patients may be enrolled within 45 days from the time of treatment initiation
Major exclusion criteria
  • Patient is currently enrolled in any interventional clinic trial with a non-approved investigational agent for the primary disease of CRPC at study entry
  • Patient is receiving concomitant treatment for other cancer (excluding basal cell carcinoma and treatment for hormone sensitive prostate cancer) within 6 months prior to enrollment

Low testosterone

TRAVERSE Study – Men with Low-T with Increased Cardiovascular (CV) Risk

The purpose of this study is to evaluate cardiovascular (CV) risk in middle-ages and older hypogonadal men treated with testosterone replacement therapy (TRT).

Eligibility Criteria
Major inclusion criteria
  • Men age between 45 and 80 years (inclusive)
  • Meet study definition of clinical hypogonadism and who are naïve to testosterone replacement OR has not been treated with TRT within last 6 month
  • Has pre-existing CV disease
Major exclusion criteria
  • Congenital or acquired hypogonadism for whom long-term therapy with placebo would not be medically appropriate
  • History of prostate or breast cancer or prostate nodule or induration at screening DRE
  • PSA >3.0 ng/mL and IPSS >19

Clinical Trials

For more information about current clinical trials or the clinical trial process at Urology Associates, contact Lenden Neeper:

303-733-8848

[email protected]