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UNC Lineberger’s Angela B. Smith, MD, MS, an associate professor in the UNC School of Medicine Department of Urology and director of urologic oncology, and her collaborators were awarded a contract from the Patient-Centered Outcomes Research Institute to compare bladder removal with medical therapy in bladder cancer patients.


University of North Carolina Lineberger Comprehensive Cancer Center and University of Washington researchers have been awarded an $8.5 million contract to launch a study comparing two treatments for patients with non-muscle invasive bladder cancer that has come back or worsened.

UNC Lineberger’s Angela B. Smith, MD, MS, an associate professor in the UNC School of Medicine Department of Urology and director of urologic oncology, is co-principal investigator for the study with John Gore, MD, MS, of the University of Washington. They were awarded the contract from the Patient-Centered Outcomes Research Institute to compare bladder removal with medical therapy in bladder cancer patients.

“The goal will be to provide information to future patients, their caregivers, and their providers so the patients can choose the treatment that best meets their needs based on the outcomes and preferences of patients most similar to themselves,” Smith said.

The study will compare the experiences and outcomes for patients for up to three years after they were treated for recurrent non-muscle invasive bladder cancer. Initially, this disease can be treated with a less-invasive, endoscopic procedure that removes the tumor, but leaves the bladder intact, along with a device that can deliver drugs into the bladder. But when the cancer comes back, patients must choose between surgery, or additional medical treatment, which comes with a risk of the cancer worsening.

“When the tumor recurs, patients face a difficult choice,” Smith said. “They can undergo a surgery to remove their bladder – which is likely to cure them, but can have a negative impact on their daily life. The other option is to try additional medical treatments, but these treatments do not work as well. For some patients, their cancer may worsen and spread outside the bladder.”

Researchers worked with the Bladder Cancer Advocacy Network, an advocacy organization for patients with bladder cancer, to create a survey network of more than 1,300 patients with bladder cancer. They designed the study to answer these patients’ top questions, including: “What are the best treatments for patients whose cancer returns or worsens after BCG treatment?” Throughout the study, a team of patients and caregivers will provide input into the study design and sharing of results, and they will hold regular meetings, blog posts and webinars.