Urological Clinical Research Studies and Cancer Clinical Trials

Foothills Urology in Denver, Colorado, participates in clinical research studies and clinical trials for various urological conditions, including prostate cancer, erectile dysfunction, low testosterone, lichen sclerosis, and urinary incontinence. Participating in these urological clinical research studies provides our patients access to the latest treatments that are on the forefront of medical therapies.

Continue reading below to learn more about clinical research studies and clinical trials, and our current research. Or click on a specific question to be taken directly to that section of the page.

 

What are clinical research studies and clinical trials?

Clinical research studies and clinical trials provide ways for medical researchers to gain or increase knowledge about the treatment, diagnosis, and prevention of diseases and health conditions. At Foothills Urology, we participate in various forms of clinical research studies and clinical trials across a wide range of urological conditions. All clinical trials we offer to our patients have been reviewed and approved by an external Institutional Review Board.

In a clinical trial, participants receive specific interventions or treatments according to a research plan or protocol created by the Pharmaceutical Companies and study investigators. These interventions may involve the use of medical products, such as drugs or devices; procedures; or changes to participants' behavior, such as diet. Clinical research studies are under the oversight of the US Food and Drug Administration and an Institutional Review Board.

Clinical research studies or trials are sponsored and funded by:

  • Government agencies, such as the National Institutes of Health
  • Health organizations like the National Cancer Institute
  • Academic medical centers
  • Pharmaceutical companies and medical device manufacturers

Clinical trials are led by a principal investigator, often a medical doctor. Dr. David Cahn, a board-certified urology surgeon with more than 20 years of clinical experience, serves as the principal investigator for the clinical research studies conducted through Foothills Urology in Colorado.

 

What are the types of clinical research studies and clinical trials?

Clinical research trials fall into five phases:

Phase 0 trials. These types of trials are often referred to as “first in human testing,” as they are the first clinical trials done with people.

Phase 1 trials. These trials are conducted on a small number of people and are designed to see if a treatment is safe. With new drugs, for example, Phase I trials aim to find the best dose of a new drug with the fewest side effects.

Phase 2 trials. After a treatment is considered to be relatively safe, it is evaluated in a phase 2 trial to see if it is effective, and also to further assess safety.

Phase 3 trials. If a treatment is found to be relatively safe and effective, it is then evaluated in a phase 3 trial to see if it is more effective or has fewer side effects than standard treatments. With drug trials, for example, the new drug may be compared to a standard of care drug in a phase 3 clinical trial. If a drug is found to be more effective or safer in a phase 3 trial, it may then be evaluated for FDA approval.

Phase 4 trials. Because a medication usually is approved (or not approved) by the FDA on completion of a phase 3 trial, phase 4 trials are done after FDA approval. For example, Phase 4 trials may be done to determine if a cancer drug that works for one subtype of cancer might be effective on another subtype of cancer. Phase 4 drug trials may be tested in hundreds or thousands of patients.

 

Are clinical research studies safe?

Clinical research trials are approved and monitored by an Institutional Review Board (IRB). An IRB is a committee that is responsible for reviewing clinical research trials to protect the rights and safety of people who take part in research, both before the research starts and as it is conducted. An IRB helps ensure that research protocols are followed, patient harm is minimized, and the benefits of the trial outweigh the risks to participants. The Department of Health and Human Services Office for Human Research Protections has oversight responsibilities for Institutional Research Boards. In addition to monitoring by the IRB, clinical trials are tightly controlled, monitored and documented by the principal investigator and study team.

Clinical research studies may involve some risks. Since clinical  trials involve testing of new treatments, possible risks and side effects of the treatment are not always fully known until a trial is completed. Some trials are randomized and “blinded.” Randomization applies to studies where some participants receive the treatment being studied, while others get a placebo or no treatment at all. Participants in these types of studies are randomly assigned to each group. Many trials are blinded, which means study investigators and patients do not know which participant falls into which group; this is done so investigators do not do anything that might bias research study results.

 

Who is eligible to participate in clinical research studies and clinical trials?

Clinical trials have strict standards about who can participate. Eligibility for clinical research studies varies based on the purpose of the trial and the drug, device, or treatment that is being studied. According to the National Institutes of Health, research trial eligibility criteria can include factors such as a patient's age, gender, and ethnic group, the type and stage of disease, and whether the patient has had certain treatments, or has other health problems.

Patients participate in clinical research trials for many reasons, including getting access to the latest treatments and a desire to help advance the understanding and treatment of their condition.

 

How can I participate in clinical research studies or clinical trials near me?

To see if you qualify for any of the clinical trials currently being conducted at Foothills Urology:

  • Review the list of current clinical trials below and click on the link to learn more about each study.
  • Contact Deborah Aggers, CCRP, Foothills Urology Director of Clinical Research, at 303-985-2550, ext. 320, with questions or to see if you are eligible to participate.

 

What are the current clinical research studies and clinical trials available at Foothills Urology in Denver?

Foothills Urology is currently participating in the following clinical research studies; clinical trials are still open to participants unless noted. 

Prostate Cancer

  • Dendreon study — Prostate Cancer Dendreon Pharmaceuticals LLC/“A Randomized Phase 3, Open-label Trial of Sipuleucel-T Administered to Patients on Active Surveillance for Newly Diagnosed Prostate Cancer”
  • Advantagene Prostate Cancer — A Randomized Controlled Trial of ProstAtak® as Adjuvant to Up-front Radiation Therapy For Localized Prostate Cancer
  • Advantagene Prostate Cancer — A Randomized Controlled Trial Of AdV-tk + Valacyclovir Administered During Active Surveillance For Newly Diagnosed Prostate Cancer
  • Veru — Hot Flash Study Randomized, double-blind, placebo controlled, dose finding Phase 2 study comparing oral daily dosing of VERU-944 after a week of loading (daily dosing) with placebo to ameliorate the vasomotor symptoms resulting from androgen deprivation therapy in men with advanced prostate cancer

Low Testosterone

  • TRAVERSE study — Testosterone Replacement therapy for Assessment of long-term Vascular Events and efficacy ResponSE in hypogonadal men

 

How can I be notified of new clinical research studies near me?

To be added to our clinical research studies mailing list, fill out the form on the right side of this page and we will email you as new trials become available.

 

Where can I learn more about clinical research studies and clinical trials?

Reputable sources of information about clinical research studies and clinical trials include: