10/07/2010 -Vanderbilt-Ingram Cancer Center has received a $7.6 million American Recovery and Reinvestment Act of 2009 (ARRA) stimulus grant to coordinate a study comparing the effectiveness of various treatments for prostate cancer.
Funded by the Agency for Healthcare Research and Quality, the three-year grant is part of the CHOICE award program that uses federal ARRA stimulus money to support studies comparing the effectiveness of treatments for high-priority conditions identified by the Institute of Medicine.
David Penson, M.D., MPH, professor of Urologic Surgery, will serve as Principal Investigator for the Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study on prostate cancer.
Daniel Barocas, M.D., MPH, assistant professor of Urologic Surgery, and Tatsuki Koyama, Ph.D., assistant professor of Biostatistics, will serve as co-investigators.
“Prostate cancer is the most common solid tumor and the second leading cause of cancer death among American men,” said Penson, director of the Center for Surgical Quality and Outcomes Research in the Vanderbilt Institute for Medicine and Public Health.
“Screening tests usually allow us to catch the cancer early before it has spread outside the prostate, but we don’t really know the best way to treat the disease when it is localized. The study will help us determine a scientific basis for what works best, in which patients, and in whose hands.”
Surgery to remove the prostate, performed through an open incision or with a robot, radiation delivered from outside the body or by internally implanting radioactive seeds, and cryotherapy to kill cancer cells by surgically freezing the prostate are standard treatments for localized prostate cancer.
However, all of these treatments run the risk of side-effects, including urinary problems like incontinence, bowel problems and erectile dysfunction.
“Given these side-effects and the fact that some of the cancers we detect are so slow-growing they would never cause any problems, it is sometimes reasonable to provide active surveillance instead of aggressive treatment,” said Penson. “We just don’t know which approach is best and this study is designed to help us answer these questions.”
Vanderbilt will coordinate the CEASAR study which involves five other clinical sites, including University of Southern California, Emory University, University of California San Francisco, University of Medicine and Dentistry New Jersey and Louisiana State University, two research methodology sites at University of California Irvine and MD Anderson Cancer Center, and a team of internationally known experts as consultants.
CEASAR will use a network of state and city tumor registries and a national disease registry to enroll 4,200 men who were just diagnosed with localized prostate cancer, and will follow their cases for a year.
The researchers will collect key patient-reported outcomes, such as health-related quality of life and side-effects of therapy.
The investigators also will collect clinical data, including technical details of treatment, complications, short-term cancer recurrence rates and quality-of-care indicators.
“We will then compare outcomes and identify which therapies work best in which types of patients,” explained Penson. “We will assess the quality of care delivered, in hopes of helping patients identify the kinds of cancer centers that provide the best prostate cancer care.”©2016 Vanderbilt University Medical Center