City of Hope Launches Phase 2 Trial Testing Heart Protection Strategies for Prostate Cancer Patients on Hormone Therapy
核心洞察
City of Hope (搜索) has opened a phase 2 clinical trial comparing three different strategies to protect heart health in prostate cancer (搜索) patients receiving androgen deprivation therapy (搜索) (ADT).
The study will test intermittent fasting, GLP-1 receptor agonist (搜索) medication, and American Heart Association guidelines over six months to reduce cardiovascular and metabolic risks.
Researchers aim to identify which intervention provides the greatest cardiometabolic benefit for patients who face increased risk of heart attack and stroke from ADT treatment.
City of Hope (搜索) has launched a phase 2 clinical trial to address a critical challenge in prostate cancer (搜索) care: protecting patients' heart health while they receive potentially lifesaving androgen deprivation therapy (搜索) (ADT). The study will compare three different intervention strategies aimed at reducing the cardiovascular and metabolic risks associated with this cornerstone hormone treatment.
Trial Design and Interventions
The IMPACT-ADT trial (NCT07202247) will evaluate three distinct approaches over a six-month period: intermittent fasting with a 16-hour fasting window, an anti-obesity medication targeting the body's natural glucagon-like peptide-1 (搜索) (GLP-1) signaling pathway, and implementation of the American Heart Association's Life's Essential 8 guidelines. Participants will continue their standard cancer treatment of radiation and hormone therapy while following one of these assigned interventions.
"ADT is a cornerstone of prostate cancer (搜索) 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 (搜索). "Addressing these metabolic and cardiovascular consequences is essential to improving overall health, reducing long-term morbidity and optimizing outcomes for patients undergoing cancer therapy."
Addressing Treatment-Related Cardiovascular Risk
Prostate cancer (搜索) patients receiving ADT face increased risk of cardiovascular disease (搜索), including heart attack, stroke and other heart and blood vessel problems. These risks may stem from treatment-related metabolic changes that can lead to weight gain, insulin resistance and increased body fat accumulation.
The trial aims to enroll 60 study participants who will undergo comprehensive assessments of their metabolic and cardiovascular health, including clinical endpoints, biomarkers, imaging and other evaluation tools. Patients will be monitored for 12 months after completing the intervention portion of the study to assess long-term outcomes.
Research Goals and Clinical Impact
The study's primary objective is to determine whether these interventions, already widely used in other clinical settings, are feasible and safe for prostate cancer (搜索) patients receiving hormone therapy. The research builds on Dr. Li's previous work focused on mitigating side effects of cancer treatments, including radiotherapy and ADT.
"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 (搜索)'s Division of Cardiology and 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 study represents an important step toward optimizing care for prostate cancer (搜索) patients by addressing the balance between effective cancer treatment and long-term cardiovascular health outcomes.