City of Hope Opens Clinical Trial to Protect Heart Health of Prostate Cancer Patients Receiving Hormone Therapy

Study compares intermittent fasting, GLP-1 medication and nutritional counseling to reduce cardiovascular and metabolic risks from androgen deprivation therapy

LOS ANGELES--(BUSINESS WIRE)--City of Hope^®, one of the largest and most advanced cancer research and treatment organizations in the United States with its National Medical Center ranked among the nation’s top cancer centers by U.S. News & World Report, has opened a phase 2 clinical trial comparing three different strategies for protecting heart health in prostate cancer patients who receive androgen deprivation therapy (ADT), a potentially lifesaving hormone therapy.

“ADT is a cornerstone of prostate cancer treatment, but it can have significant unintended effects on cardiometabolic health,” said principal investigator Yun Rose Li, M.D., Ph.D., assistant professor and physician-scientist in the Department of Radiation Oncology at City of Hope. “Addressing these metabolic and cardiovascular consequences is essential to improving overall health, reducing long-term morbidity and optimizing outcomes for patients undergoing cancer therapy.”

The purpose of the study is to offset risk so people can continue to benefit from lifesaving ADT cancer treatment. Prostate cancer patients who receive ADT are at increased risk of cardiovascular disease, including heart attack, stroke and other heart and blood vessel problems. This may be due to treatment-related metabolic changes that can lead to weight gain, insulin resistance and an increase in body fat.

A focus of Dr. Li’s lab has been on mitigating the side effects of cancer treatments, including radiotherapy and ADT. The new trial builds on her previous work.

The trial will compare three approaches: intermittent fasting with a 16-hour fasting window, an anti-obesity medication targeting the body’s natural glucagon-like peptide-1 (GLP-1) signaling pathway and the American Heart Association’s Life’s Essential 8 guidelines. Participants will be assigned to follow one of these approaches for six months while continuing their cancer treatment of radiation and hormone therapy.

Researchers will conduct comprehensive assessments of participants’ metabolic and cardiovascular health, including clinical endpoints, biomarkers, imaging and other tools. Patients will be followed for 12 months after they complete the intervention portion of the study.

The trial’s primary goal is to determine if these interventions, which are already widely used in other clinical settings, are also feasible and safe for prostate cancer patients receiving hormone therapy.

“We hope to identify which strategy provides the greatest benefit for cardiometabolic health and which patients will benefit the most from prophylactic intervention,” said June-Wha Rhee, M.D., associate professor in City of Hope’s Division of Cardiology and a fellow study investigator. “These insights will inform future cancer care practices and help refine subsequent research aimed at mitigating treatment-related metabolic and cardiovascular risks.”

The clinical trial (NCT07202247) “Metabolic Interventions (Time-Restricted Eating, GLP1 Receptor Agonist, and Heart Healthy Diet) to Improve Cardiometabolic Health in Prostate Cancer Patients During Androgen Deprivation Therapy, IMPACT-ADT Trial” aims to accrue 60 study participants.

About City of Hope

City of Hope's mission is to make hope a reality for all touched by cancer and diabetes. Founded in 1913, City of Hope has grown into one of the largest and most advanced cancer research and treatment organizations in the United States, and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines, as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center that is ranked among the nation’s top cancer centers by U.S. News & World Report at its core, City of Hope’s uniquely integrated model spans cancer care, research and development, academics and training, and a broad philanthropy program that powers its work. City of Hope’s growing national system includes its Los Angeles campus, Orange County, California, campus, a network of clinical care locations across Southern California and cancer treatment centers and outpatient facilities in the Atlanta, Chicago and Phoenix areas. City of Hope’s affiliated group of organizations includes Translational Genomics Research Institute and AccessHope^TM. For more information about City of Hope, follow us on Facebook, X, YouTube, Instagram and LinkedIn.