Ronald Chen, MD, MPH, a UNC Lineberger member and an associate professor in the UNC School of Medicine Department of Radiation Oncology, has been awarded a $2.09 million, three-year contract from the Patient-Centered Outcomes Research Institute to work on that question. The funding will allow Chen and collaborators to continue to track the side effects and other outcomes experienced by about 1,700 people with prostate cancer.
“Through this research, we plan to build a better understanding of the side effects and quality of life outcomes from modern treatment technologies for prostate cancer,” said Chen, the study’s principal investigator. “Most of the published research in this area examines older types of radiation and surgery that are no longer commonly used.”
The study is a continuation of work that began in 2011. Between January 2011 and June of 2013, the researchers recruited about 1,500 patients who had been newly diagnosed with prostate cancer from across North Carolina. Using UNC Lineberger’s Rapid Case Ascertainment program, the researchers were able to identify patients early after diagnosis.
“This is a great example of a UNC Lineberger service which allowed patients and hospitals from across North Carolina to participate in research,” Chen said of the Rapid Case Ascertainment program.
Another approximately 200 people were recruited from outside the state.
The researchers have followed up with the patients by phone to track their quality of life outcomes before and after treatment. These outcomes include urinary, bowel sexual dysfunction problems that result from radiation or surgery.
In addition, they also researching other outcomes such as survival rates and cancer recurrence. They will compare those outcomes for patients across different treatments. A primary goal of the study is to help patients make treatment decisions.
“Today, patients can choose to watch the cancer without treatment, they can choose between different types of radiation, or they can choose surgery, and there’s different types of surgery,” Chen said. “We don’t have great research to compare them against each other to tell patients what’s best. So the primary goal for this study is to try to collect data about these modern treatments, and provide patients with data to help them make decisions.”
The new grant will allow them to continue tracking the outcomes of patients for another three years. And Chen hopes to secure funding beyond that.
He said gauging quality of life after treatment for prostate cancer is important as it’s considered a highly curable cancer. The five-year relative survival rate for prostate cancer is nearly 99 percent, according to data from the National Cancer Institute Surveillance, Epidemiology and End Results Program.
The project was designed with patient input, which Chen said was important to the project mission. A stakeholder group of patients, policymakers, doctors and researchers helped with the design, and the Prostate Cancer Coalition of North Carolina helped with the materials used to recruit patients.
“This new research model brings in patients at the very beginning to collaborate and ask them: What are the questions that are most important?” he said.
The contract award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract to UNC Lineberger. PCORI is an independent, non-profit organization authorized by Congress in 2010 to fund comparative clinical effectiveness research that will provide patients, their caregivers, and clinicians with evidence-based information needed to make better-informed health and healthcare decisions.
In addition to Chen, other collaborators on the project include Paul Godley, MD, PhD, MPP, a UNC Lineberger member and a professor in the UNC School of Medicine Division of Hematology/Oncology; Matthew Nielsen, MD, MS, a UNC Lineberger member and director of urologic oncology in the UNC School of Medicine Department of Urology; Bryce Reeve, PhD, associate professor at the UNC Gillings School of Global Public Health; Bill Carpenter, PhD, an adjunct associate professor at the UNC Gillings School of Global Public Health; and Anne-Marie Meyer, PhD, a research assistant professor at the UNC School of Medicine and faculty director of the UNC Lineberger Integrated Cancer Information and Surveillance System.