University of Maryland School of Medicine Researchers Awarded Funding to Lead National Discussion on Active Surveillance for Men with Low-Risk Prostate Cancer

PCORI-Funded Initiative to Bring Together Patients, Doctors and Other Key Stakeholders to Explore Use of Monitoring for Eligible Patients Versus Immediate Treatment

Researchers at the University of Maryland School of Medicine (UMSOM) have been awarded $100,000 in funding through the Eugene Washington PCORI Engagement Awards, an initiative of the Patient-Centered Outcomes Research Institute (PCORI). The funds will support a national discussion and conference aimed at identifying evidence gaps to guide future research on the use of active surveillance to monitor low-risk prostate cancers. This serves as an alternative to immediate treatment with surgery, radiation or hormone therapy which all have potential debilitating side effects.

Overtreatment of prostate cancer has become a significant issue in recent years, especially as better imaging and other technologies have enabled doctors to distinguish more aggressive cancers from low-risk ones. Aggressive cancers need to be immediately treated with surgery and radiation therapy whereas low-risk ones can be monitored without immediate treatment to determine whether they will grow and become potentially life threatening.

Current clinical guidelines recommend active surveillance to manage low-risk prostate cancer, starting treatment only if the cancer progresses. Data have shown in properly selected patients that survival is equivalent with this approach, compared to immediate treatment. Less than half of eligible men, however, opt for active surveillance, and about 30 percent of men who initially choose this approach decide to pursue treatment even if there is no evidence their cancer is progressing.

"The question is, why are we not doing active surveillance in suitable patients when it's well-demonstrated to be effective, safe and a good way to avoid the complications of treatment," said M. Minhaj Siddiqui, MD, an associate professor of surgery at UMSOM and director of urologic oncology and robotic surgery at the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC), located at the University of Maryland Medical Center.

"We want to identify what the issues are and what type of work needs be done to improve the utilization of active surveillance for men with prostate cancer in the United States," said Dr. Siddiqui, who is leading the project. "We are bringing together patients, spouses and caregivers, advocacy organizations, prostate cancer specialists and professional organizations to develop a list of high-impact, answerable questions to guide future research on this issue."

"To my knowledge, this is the first time that a project of this magnitude and organizational backing is being done to address active surveillance of prostate cancer," he said.

Prostate cancer is the most common cancer in men, with more than 200,000 men diagnosed in the United States each year. In Maryland, the American Cancer Society estimates there will be 5,000 new prostate cancer cases this year. About 90 percent of men diagnosed with prostate cancer have low-risk disease and don't require aggressive therapy. "The majority of these men will live their natural lives and die of other causes," Dr. Siddiqui said.

"Overtreatment of prostate cancer is a very real concern, and we need to have a better understanding of why many men decide against close monitoring of their cancer in favor of often medically unnecessary treatment," said Dean E. Albert Reece, MD, PhD, MBA, Executive Vice President for Medical Affairs, UM Baltimore, and the John Z. and Akiko K. Bowers Distinguished Professor at the University of Maryland School of Medicine. "This research is an important first step in identifying and addressing some of the underlying issues in a national forum."

The initiative includes the creation of a diverse advisory board and putting together a national conference to discuss the challenges of utilizing active surveillance and identify potential areas for future research.

Dr. Siddiqui said there are many reasons that men forgo or discontinue active surveillance, including their own preferences, physician counseling, influence of families or support networks, distrust of delaying treatment, and lack of access to reliable information.

E. Michael D. (Mike) Scott, the president and executive director of Prostate Cancer International, a not-for-profit organization that promotes education and awareness of prostate cancer, said there is often "a vast communications gap" and "misalignment of goals" between patients and clinicians.

"When men are diagnosed with prostate cancer, they may hear the word cancer and think they need to 'do something' to treat it immediately. Doctors, eager to offer patients a 'cure,' may recommend treatment that can result in side effects such as incontinence and reduced sexual function," Scott said. "Active surveillance is often not part of the discussion." He added, "One of the most critical questions we need to address is whether there are things men can do to delay progression while on active surveillance, thus optimizing their quality of life."

"This initiative gives patients a voice in formulating research to address concerns about active surveillance for early-stage prostate cancer," said C. Daniel Mullins, PhD, professor and chair of the Department of Pharmaceutical Health Services Research at the University of Maryland School of Pharmacy (UMSOP). “The goal of patient-centered research like this is to help patients work with their doctors to make better-informed decisions about their care." Dr. Mullins is executive director of the PATIENTS Program at UMSOP, which fosters patient-centered and community-engaged research and will support the new initiative.

The research is part of a portfolio of projects that PCORI has funded to help develop a community of patients and other stakeholders equipped to participate as partners in comparative clinical effectiveness search (CER) and disseminate PCORI-funded research results. Through the Engagement Award Program, PCORI is creating an expansive network of individuals, communities and organizations interested and able to participate in, share and use patient-centered CER.

About the University of Maryland School of Medicine

Now in its third century, the University of Maryland School of Medicine was chartered in 1807 as the first public medical school in the United States. It continues today as one of the fastest growing, top-tier biomedical research enterprises in the world -- with 45 academic departments, centers, institutes, and programs; and a faculty of more than 3,000 physicians, scientists, and allied health professionals, including members of the National Academy of Medicine and the National Academy of Sciences, and a distinguished two-time winner of the Albert E. Lasker Award in Medical Research. With an operating budget of more than $1.2 billion, the School of Medicine works closely in partnership with the University of Maryland Medical Center and Medical System to provide research-intensive, academic and clinically based care for nearly 2 million patients each year. The School of Medicine has more than $563 million in extramural funding, with most of its academic departments highly ranked among all medical schools in the nation in research funding. As one of the seven professional schools that make up the University of Maryland, Baltimore campus, the School of Medicine has a total population of nearly 9,000 faculty and staff, including 2,500 student trainees, residents, and fellows. The combined School of Medicine and Medical System ("University of Maryland Medicine") has an annual budget of nearly $6 billion and an economic impact more than $15 billion on the state and local community. The School of Medicine, which ranks as the 8th highest among public medical schools in research productivity, is an innovator in translational medicine, with 600 active patents and 24 start-up companies. The School of Medicine works locally, nationally, and globally, with research and treatment facilities in 36 countries around the world. Visit www.medschool.umaryland.edu.

About the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center

The University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) is a National Cancer Institute-designated Comprehensive Cancer Center in Baltimore. The center is a joint entity of the University of Maryland Medical Center and University of Maryland School of Medicine. It offers a multidisciplinary approach to treating all types of cancer and has an active cancer research program. It is ranked among the top cancer programs in the nation by U.S. News & World Report. www.umgccc.org.