City of Hope Launches Phase 2 Trial to Safeguard Heart Health in Prostate Cancer Patients on ADT
City of Hope, a prominent cancer research and treatment organization, has initiated a phase 2 clinical trial. The trial aims to evaluate three different methods for protecting heart health in prostate cancer patients undergoing androgen deprivation therapy (ADT).
The primary objective is to determine the feasibility and safety of these interventions for prostate cancer patients receiving hormone therapy.
Understanding the Challenge: ADT's Cardiometabolic Risks
ADT is a standard treatment for prostate cancer. However, it is associated with cardiometabolic side effects. These effects include an an increased risk of cardiovascular diseases like heart attack and stroke, potentially due to metabolic changes such as weight gain and insulin resistance.
Three Approaches Under Evaluation
The study will compare three distinct approaches over a six-month period. Participants will continue their existing radiation and hormone therapy while following one of these assigned interventions:
- Intermittent fasting: Involving a 16-hour fasting window.
- An anti-obesity medication: Specifically targeting the GLP-1 signaling pathway.
- Adherence to the American Heart Association's Life's Essential 8 guidelines.
Trial Methodology and Monitoring
Researchers will conduct detailed assessments of participants' metabolic and cardiovascular health. This will utilize clinical endpoints, biomarkers, and imaging techniques. Following the completion of the intervention phase, patients will be monitored for an additional 12 months.
Goals and Future Implications
Investigators hope to identify which strategy offers the greatest benefit for cardiometabolic health and which patient groups may benefit most from early intervention. These findings are expected to contribute significantly to future cancer care practices and guide further research into mitigating treatment-related metabolic and cardiovascular risks.