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RecruitingPhase 2

Metabolic Interventions (Time-Restricted Eating, GLP1 Receptor Agonist, and Heart Healthy Diet) to Improve Cardiometabolic Health in Prostate Cancer Patients During Androgen Deprivation Therapy, IMPACT-ADT Trial

A Phase II Randomized Study of Interventions for Metabolic Protection Against Cardiometabolic Toxicity During Androgen Deprivation Therapy (IMPACT-ADT)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
30 Years to 79 Years
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months
  • Procedures mentioned: Questionnaires, Blood draws, CT scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "ARM 1 (TRE): Patients receive radiation therapy (RT) and ADT per standard of care (SOC), as well as participate in an overnight fast over 16 hours on at least 5 days weekly for 6 months."
  • "Patients also receive TRE reminders, dietary education, and complete survey and food diary collection via the Oncpatient Companion Mobile Application (app)."
  • "In addition, patients receive diet/lifestyle counseling as per AHA HHD guidelines and AHA Life Essential 8 recommendations with personalized caloric intake for 6 months."
  • "ARM 2 (GLP1-RA): Patients receive RT and ADT per SOC for 6 months."
  • "Patients receive a referral to an endocrinologist and receive semaglutide or tirzepatide subcutaneously (SC) once weekly (QW) for 6 months in the absence of disease progression or unacceptable toxicity."
  • "Patients also receive dietary education and complete survey and food diary collection via the Oncpatient Companion Mobile app."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares eating only during set hours each day or taking semaglutide or tirzepatide with a heart-healthy diet. It tests whether these approaches improve heart health and how the body uses food for energy. It is for men with prostate cancer who plan to receive 6 months of hormone therapy and meet weight and health requirements.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be a man age 30–79 who speaks English, Spanish, or Mandarin.
  • Give written consent to join the study.
  • Allow use of stored tissue from your cancer biopsy. The study leader may make an exception if none is available.
  • Be able to care for yourself and be out of bed or a chair for at least half of your waking hours.
  • Meet requirements for insurance coverage for the study medicines: a body mass index (BMI, a measure of weight compared with height) of 30 or higher, or 27 or higher with a weight-related health problem, such as high blood pressure, type 2 diabetes, or unhealthy blood fat levels.
  • Have either medium-risk prostate cancer being treated with radiation, or prostate cancer that remains or returns based on blood tests after prostate removal and is being treated with radiation.
  • Plan to receive hormone therapy that lowers male hormones for 6 months.

Who can't join

  • Already follow a strict diet that limits food types or eating times, such as keto, low-carb, paleo, or warrior diets.
  • Already take a GLP1 medicine.
  • Have diabetes that is not well controlled.
  • Cannot follow a plan that limits eating to set hours.
  • Cannot take the study medicines because of a drug allergy, past pancreas swelling, or kidney disease in its final stage.
  • Have a personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2, a condition that causes tumors in hormone-making glands.
  • Have another active illness that your treating doctor says makes you unable to join.
  • The study team thinks you may not be able to follow all study steps, including because of scheduling or travel problems.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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)

Study sites (1)

CA