With a $1.2 million grant to the University of Oklahoma, an OU Health urologic oncologist is leading an innovative new clinical trial for the treatment of prostate cancer when the cancer is beginning to spread beyond the prostate. The trial, offered at OU Health Stephenson Cancer Center, will study the combination of two drugs, each of which is already used to treat prostate cancer but has not been evaluated together.

Prostate cancer is the most common cancer in men and the second-leading cause of cancer death in the United States. The National Cancer Institute estimates there will be nearly 300,000 new prostate cancer diagnoses in 2024 and more than 35,000 deaths. The cancer is more likely to occur in men with a family history of prostate cancer and men of African American descent. Oklahomans with prostate cancer are more likely to be diagnosed when the cancer is advanced.

“For patients with aggressive prostate cancer who are at risk of poor outcomes, we need a better understanding of what the best treatments are. We think these two drugs will be more effective when given together, and this clinical trial will allow us to evaluate how people respond to and tolerate them,” said Kelly Stratton, M.D., an associate professor of urology in the OU College of Medicine and urologic oncologist at OU Health.

The two drugs are relugolix (brand name Orogovyx) and enzalutamide (brand name Xtandi). Relugolix aims to stop the body’s production of testosterone, which the cancer needs to grow and spread. Previously only available as an injection, relugolix is a new oral drug that may result in fewer side effects. Should any testosterone be made — even if the tumor itself makes it — enzalutamide blocks it so the tumor can’t use it to grow.

In the trial, patients will receive the drug combination in addition to either radiation therapy or surgery to remove the prostate gland, which are standard treatments for this type of cancer. As a Phase 1B clinical trial, there is no control group for comparison; all patients will receive the drug combination.

The clinical trial is funded by a grant from National Comprehensive Cancer Network’s Oncology Research Program, which fosters innovation and knowledge discovery to improve the lives of patients with cancer. Stratton is the national leader of this study, and OU Health Stephenson Cancer Center is one of only four cancer centers in the United States to be awarded grant funding through this prostate cancer project.

“We’re excited to offer patients this trial for aggressive, high-risk prostate cancer, and it’s what we think the treatment of the future will be,” Stratton said. “That is one of the benefits of being treated at a National Cancer Institute-designated cancer center like Stephenson Cancer Center — patients are able to receive tomorrow’s treatments today.”

For more information about the trial at Stephenson Cancer Center, call (405) 271-4088 or email SCCIITOffice@ouhsc.edu.

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About the Project

Details about trial eligibility and timeline is available here. More information about other prostate cancer studies that were funded is available at this link.

About the University of Oklahoma

Founded in 1890, the University of Oklahoma is a public research university located in Norman, Oklahoma. As the state’s flagship university, OU serves the educational, cultural, economic and health care needs of the state, region and nation. OU was named the state’s highest-ranking university in U.S. News & World Report’s most recent Best Colleges list. For more information about the university, visit www.ou.edu.