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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• City of Hope Medical Center
  Duarte, California, United States Recruiting

Study contacts

• Principal investigator: Rose Li — City of Hope Medical Center

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.