Metabolic strategies — time‑restricted eating, GLP‑1 medicines, and a heart‑healthy diet to protect heart and metabolic health during hormone therapy for prostate cancer
A Phase II Randomized Study of Interventions for Metabolic Protection Against Cardiometabolic Toxicity During Androgen Deprivation Therapy (IMPACT-ADT)
This trial tests whether time‑restricted eating or GLP‑1 drugs (semaglutide or tirzepatide), combined with heart‑healthy diet counseling, can protect heart and metabolic health in men receiving androgen‑deprivation therapy for prostate cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 30 Years to 79 Years |
| Sex | Male |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Duarte, California) |
| Trial ID | NCT07202247 on ClinicalTrials.gov |
What this trial studies
This randomized Phase II trial enrolls men with prostate cancer receiving androgen‑deprivation therapy and assigns them to one of three arms: a time‑restricted eating (16‑hour overnight fast at least 5 days/week) arm plus AHA heart‑healthy diet counseling, a GLP‑1 receptor agonist arm (semaglutide or tirzepatide) plus diet counseling, or an AHA heart‑healthy diet counseling control arm. Interventions are delivered during approximately six months of ADT with regular reminders, dietary education, app‑based diaries, and clinical follow‑up. The study measures cardiometabolic outcomes (weight, insulin resistance, inflammatory and metabolic biomarkers), cardiac CT angiography, biospecimen analyses, tolerability, and quality of life. Exploratory endpoints include metabolome and inflammasome changes, clonal dynamics, and coronary plaque characteristics.
Who should consider this trial
Good fit: Men aged 30–79 with prostate cancer receiving or planning short‑term ADT who have obesity (BMI ≥30) or BMI ≥27 with a weight‑related comorbidity and can attend City of Hope visits are ideal candidates.
Not a fit: Men who are normal weight without metabolic comorbidities, those with contraindications to GLP‑1 receptor agonists, or those unable to follow fasting schedules or clinic visits may be unlikely to benefit.
Why it matters
Potential benefit: If successful, these interventions could reduce weight, improve insulin resistance, and lower cardiovascular risk for men on ADT.
How similar studies have performed: Large trials have shown GLP‑1 receptor agonists reliably reduce weight and improve metabolic markers, while time‑restricted eating has promising but less definitive evidence and has not been widely tested specifically in men on ADT.
Eligibility criteria
Show full inclusion / exclusion criteria
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 condition (e.g. hypertension, type 2 diabetes mellitus, dyslipidemia) * Prostate cancer defined as one of the following: * National Comprehensive Cancer Network (NCCN) intermediate risk prostate cancer receiving definitive radiation with a plan to undergo ADT for 6 months * Biochemical persistent or recurrent prostate cancer status post prostatectomy receiving salvage radiation with a plan to undergo ADT for 6 months Exclusion Criteria: * Currently engaging in strict macronutrient/time limited diet, including ketogenic, low-carb, paleo, or warrior diet * Currently under GLP1-RA therapy * Poorly controlled diabetes * Unable to undergo time-restricted diet * Contraindications for GLP1-RA therapy: including hypersensitivity to the drug, personal history of pancreatitis, personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2, end-stage renal disease * Other active disease deemed not eligible to participant in the study according to treating physician * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Where this trial is running
Duarte, California
- City of Hope Medical Center — Duarte, California, United States (Recruiting)
Study contacts
- Principal investigator: Rose Li — City of Hope Medical Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.