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Angela B. Smith, MD, MS
Angela B. Smith, MD, MS

The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors approved $8.5 million to fund research for the Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer(CISTO).

Dr. Angela Smith of the University of North Carolina’s Urology Department and Dr. John Gore of the University of Washington’s Urology Department are co-Principal Investigators of the CISTO study in partnership with the Bladder Cancer Advocacy Network (BCAN).

The study will compare bladder-removal surgery with a treatment that delivers therapeutic agents to the bladder via a catheter to treat recurrent bladder cancer. Study findings will help patients and clinicians make an informed decision between the two treatments.

Bladder Cancer:

Bladder cancer is the 4th-most-common cancer in men and 10th-most-common cancer in women. In 2018 alone, it is estimated that over 80,000 Americans will be diagnosed with bladder cancer of which 75% had a type of bladder cancer called “non-muscle invasive bladder cancer” (NMIBC).

NMIBC is usually treated with a combination of an endoscopy procedure to remove the tumor, leaving the bladder in place, and a medical treatment called Bacillus Calmette-Guerin (BCG) that is directly placed into the bladder. That said, this type of tumor frequently returns or worsens. When that happens, patients face the difficult choice:

  • Surgically remove their bladder
  • Try additional medical treatments, including repeated BCG

Removing the bladder can severely impact daily activities and relationships, but medical treatments may not work as well and, in some patients, their cancer will continue to worsen and spread beyond the bladder.

About the CISTO study:

Dr. Smith was Principal Investigator on a PCORI Patient Engagement Award supporting work with BCAN to create a Patient Survey Network of over 1,300 bladder cancer patients. When surveyed, these patients identified their most important questions of which the top two questions for NMIBC patients were:

  • How can patients and providers make decisions about the need for bladder removal, and what is the best timing?
  • What are the best treatments for patients whose cancer returns or worsens after BCG treatment?

The CISTO study will help answer these questions while further comparing bladder removal and medical therapy as treatment avenues. The study will engage patients and their caregivers and ask about their experiences and outcomes following their treatment for NMIBC and analyze their reasons for picking a specific treatment option.

Dr. Smith and the rest of the researchers hope to provide better information to bladder cancer patients, caregivers, and providers so that all can make better treatment decisions based on the preferences and outcomes of patients with similar priorities.

In addition to BCAN, partners in this study include the American Urological Association (AUA), which will incorporate the results in educational materials and physician practice guidelines to ensure the results are utilized when informing patients about their treatment options.



About PCORI:

The Patient-Centered Outcomes Research Institute (PCORI) is an independent nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information they need to make better-informed healthcare decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work. 

About BCAN:

BCAN is the leading voice for bladder cancer in the US, providing resources to not only those diagnosed with the disease but their families, caregivers and the medical community united in support of people touched by the disease. The organization is setting the agenda for bladder cancer by promoting and funding collaborative, cutting-edge research programs, and providing critical patient support and education services. Each year, it provides thousands of patients, caregivers and the medical community with the educational resources and support services they need to navigate their bladder cancer journey.

About the AUA: 

Founded in 1902 and headquartered near Baltimore, Maryland, the American Urological Association is a leading advocate for the specialty of urology, and has more than 21,000 members throughout the world. The AUA is a premier urologic association, providing invaluable support to the urologic community as it pursues its mission of fostering the highest standards of urologic care through education, research and the formulation of health policy.