A team of researchers, clinicians, patients, and caregivers at the University of Washington, the University of North Carolina, and the Bladder Cancer Advocacy Network have been awarded funding from the Patient-Centered Outcomes Research Institute (PCORI) to compare treatment options for bladder cancer. The study, titled CISTO (Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer) compares bladder removal surgery with a treatment that delivers therapeutic agents into the bladder via a catheter for patients with high risk non-muscle invasive bladder cancer.
Bladder cancer is the 4th most common cancer among men and 10th most common among women, and 75% have non-invasive bladder cancer, a cancer that has not yet spread into the deeper muscle layers. Non-invasive bladder cancer often responds to a medication placed in the bladder, called BCG. However, some patients cannot undergo BCG treatment, either because they could not tolerate side effects or their cancer did not respond to BCG. These patients with BCG-refractory non-invasive bladder cancer are left with a difficult choice: remove their bladder (which comes with life-altering changes) or try another medication (and risk the spread of cancer throughout their body).
The CISTO study is a pragmatic trial, which means that it will study this question in real-life settings. The CISTO team is interested in understanding how patients make their decisions and evaluating outcomes that matter to them such as quality of life, survival, and decision regret. CISTO’s study question came directly from patients and caregivers affected by bladder cancer through an initiative started in 2015 called the Bladder Cancer Advocacy Network Patient Survey Network. At that time, co-Project Leads John Gore and Angie Smith partnered with the Bladder Cancer Advocacy Network (BCAN) to develop the Patient Survey Network (PSN) which includes patients and caregivers impacted by bladder cancer across the country. The initial purpose of the PSN was to prioritize important patient-centered research questions. The over 1300 members of the PSN were asked which research questions were most important to them, and the #1 prioritized research question for non-invasive bladder cancer was the basis for CISTO.
The PSN also assisted with research design for CISTO. Although researchers felt that a randomized trial would be challenging, there was no data to support this notion, so PSN members were asked about their likelihood of enrolling in a trial. They were asked whether or not they would be willing to enroll in a study in which their treatment was randomly chosen for them (i.e., a randomized trial), or in a study in which they could choose their treatment). Overwhelmingly, PSN members chose the study in which they could choose their own treatment. Under 10% of respondents indicated they would agree to have their treatment randomly chosen for them.
These survey results supported what the research team suspected and allowed the team to provide a strong argument to application reviewers as to why a randomized trial, generally the “gold standard” in research, would not be possible in this case.
The CISTO team is currently finalizing their funding contract with PCORI and putting the pieces together to start up the trial. When CISTO launches, it will be recruiting at 29 clinical sites across the country! BCAN and patient, clinical, and academic partners will be actively involved along the way, assisting with ongoing study design and conduct and providing important feedback to ensure that results reflect real-world practices and impact clinical practice.
Interested in learning more about CISTO or getting involved? Let us know!