SAN ANTONIO – With an estimated 1 in 6 American men being diagnosed with prostate cancer at some point in their lives and only 1 in 35 estimated to die of the disease*, some researchers are questioning how many of those men are receiving treatment and impairing their quality of life unnecessarily. The Cancer Therapy & Research Center (CTRC) at The University of Texas Health Science Center at San Antonio today announced it has been selected as one of five sites in the United States for the Southwest Oncology Group, the largest clinical trials group of the National Cancer Institute, to conduct a Phase III study of active surveillance therapy against radical treatment in patients diagnosed with early stage prostate cancer.
According to study coordinator Ian Thompson, M.D., professor and chairman of the Department of Urology in the UT Health Science Center School of Medicine, no other large-scale studies in North America are currently investigating where active surveillance, often referred to as watchful waiting, fits into the treatment mix. Active surveillance with selective intervention is the close monitoring of prostate cancer with the offer of treatment if there is any evidence of cancer growth. Some medical experts and scientific research suggest that some types of prostate cancer are low risk (not lethal) and may not need to be treated. For some men, the option to wait on treatment may be the best option because it allows them to avoid the risk of treatment side effects. Treatment intervention is either radiation therapy (external beam therapy or brachytherapy seed implant) or surgical removal of the prostate, depending on patient preference.
“The study looks to define the best approach for treatment of patients after a diagnosis of early stage or low-risk prostate cancer,” Dr. Thompson said. “The purpose of this study is to determine whether immediate treatment of prostate cancer is better than delayed intervention for any evidence of prostate cancer growth. We have found that active surveillance is often a very acceptable alternative for patients with early stage prostate cancer. In these men, it may mean a reduction in medical costs as well as a reduction in risk of side effects from treatment.”
The research being conducted is very similar to the numerous studies in breast cancer research comparing a lumpectomy against radical mastectomy. A lack of completed research studies involving prostate cancer is due to the historical fact that few men with prostate cancer have participated in clinical trials, perhaps due to a lack of awareness and education, Dr. Thompson suggests. He also says that this trial may not be for all newly diagnosed men, as some men may have already decided that they want to treat their cancer and others may have already decided they simply want to watch it.
“For some men, they like the idea of treating the cancer, but they don’t like the side effects. They may also like the lack of side effects of active surveillance but would also be comfortable with treatment. They find themselves having a difficult time deciding which way to go; for these men, participation in the study solves the problem with reaching a decision because it is made for them,” Dr. Thompson said. “Both options have good outcomes for localized, non-aggressive cancer and include very careful follow-up care.”
Southwest Oncology Group (SWOG), an adult cancer clinical trials cooperative group, in cooperation with The National Cancer Institute of Canada Clinical Trials Group (NCIC CTG), is funding and supporting this study. It is expected that 2,130 men from Canada, the United States and Europe will participate in this study. The study should take five years to complete and the results should be known in 15 years.
Cancer Therapy & Research Center at The University of Texas Health Science Center at San Antonio located in San Antonio, Texas, The Cancer Therapy & Research Center (CTRC) at The University of Texas Health Science Center at San Antonio is one of the nation’s leading academic research and treatment centers, serving more than 4.4 million people in the high-growth corridor of Central and South Texas including Austin, San Antonio, Laredo and the Rio Grande Valley. CTRC is one of a few elite cancer centers in the country to be named a National Cancer Institute (NCI) Designated Cancer Center, and is one of only three in Texas. CTRC handles more than 120,000 patient visits each year and is a world leader in developing new drugs to treat cancer. The CTRC Institute for Drug Development (IDD) is internationally recognized for conducting the largest oncology Phase I clinical drug trials program in the world, and participated in the clinical and/or preclinical development of many of the cancer drugs approved by the U.S. Food & Drug Administration. For more information, visit our Web site at www.ctrc.uthscsa.edu.