A Phase II Randomized Study of Interventions for Metabolic Protection Against Cardiometabolic Toxicity During Androgen Deprivation Therapy (IMPACT-ADT)
City of Hope Medical Center
Summary
This phase II trial compares the effect of time-restricted eating (TRE) and glucagon-like peptide-1 (GLP1) receptor agonists (RA), semaglutide and tirzepatide, to an American Heart Association (AHA) heart healthy diet (HHD) intervention on heart and blood vessel health (cardiovascular system) and how the body processes food for energy (metabolic system) in prostate cancer patients undergoing androgen deprivation therapy (ADT). Prostate cancer patients who are receiving hormonal therapy (ADT) are at an increased risk of cardiovascular disease. This is thought to be due to treatment-related metabolic changes which may result in increased weight, body fat, insulin resistance and an increased risk of heart attack, stroke or other heart and blood vessel problems. TRE (also known as intermittent fasting) is an eating plan that alternates between fasting and non-fasting periods. This approach limits calorie intake to a specific window of time each day. GLP1-RAs, semaglutide and tirzepatide are in a class of medications called incretin mimetics. They work by helping the pancreas to release the right amount of insulin when blood sugar levels are high. Insulin helps move sugar from the blood into other body tissues where it is used for energy. They also slow the movement of food through the stomach and may decrease appetite and cause weight loss. The AHA HHD guidelines may be an effective method to help people learn about following a heart healthy eating plan. This may lower their risk of cardiovascular disease. Metabolic interventions, TRE and GLP1-RA, may be more effective than an AHA HHD intervention alone in improving cardiovascular and metabolic health in prostate cancer patients undergoing ADT.
Description
PRIMARY OBJECTIVE: I. Evaluate whether metabolic interventions, including TRE and GLP1-RA treatment, improve the cardiometabolic health of prostate cancer (PCa) patients undergoing ADT. SECONDARY OBJECTIVES: I. Characterize the metabolic and inflammatory profiles for patients at high risk of ADT-associated cardiometabolic disease during ADT. II. Evaluate tolerability and feasibility of concurrently using GLP1-RA or performing TRE during short-term ADT. III. Examine if metabolic interventions, including TRE and GLP1 RA treatment, are associated with improved patient quality of life. EXPLO…
Eligibility
- Age range
- 30–79 years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Documented informed consent of the participant * English, Spanish or Mandarin-speaking * Agreement to allow the use of archival tissue from diagnostic tumor biopsies * If unavailable, exceptions may be granted with study principal investigator (PI) approval * Male * Aged: 30-79 * Eastern Cooperative Oncology Group (ECOG) 0-2 * High burden of cardiovascular comorbidities who would be eligible for insurance coverage for GLP1-RA therapy defined as: * Body mass index (BMI) of ≥ 30 kg/m\^2 or * BMI ≥ 27 kg/m\^2 in the presence of at least one weight-related comorbid c…
Interventions
- DrugAntiandrogen Therapy
Given ADT
- BehavioralBehavioral Intervention
Receive fasting reminders via Oncpatient Companion Mobile Application
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureCardiac Computerized Tomographic Angiography
Undergo a coronary computerized tomography angiography
- ProcedureComputed Tomography
Undergo CT
- OtherElectronic Health Record Review
Ancillary studies
- Other
Location
- City of Hope Medical CenterDuarte, California