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

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.

Conditions

• Prostate Carcinoma
• Recurrent Prostate Carcinoma

Interventions

DRUG

Antiandrogen Therapy

Given ADT

BEHAVIORAL

Behavioral Intervention

Receive fasting reminders via Oncpatient Companion Mobile Application

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Cardiac Computerized Tomographic Angiography

Undergo a coronary computerized tomography angiography

PROCEDURE

Computed Tomography

Undergo CT

OTHER

Electronic Health Record Review

Ancillary studies

OTHER

Internet-Based Intervention

Complete survey and food diary collection via Oncpatient Companion Mobile Application

BEHAVIORAL

Lifestyle Counseling

Receive diet and lifestyle counseling

OTHER

Medical Device Usage and Evaluation

Wear an activity tracker

OTHER

Nutritional Intervention

Receive AHA HHD guidelines

OTHER

Nutritional Intervention

Receive AHA Life Essential 8 recommendations with personalized caloric intake

OTHER

Questionnaire Administration

Ancillary studies

RADIATION

Radiation Therapy

Undergo RT

OTHER

Referral

Receive a referral to an endocrinologist

DRUG

Semaglutide

Given SC

OTHER

Short-Term Fasting

Participate in an overnight fast

DRUG

Tirzepatide

Given SC

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• City of Hope Medical Center

  lead OTHER

Principal Investigators

• Rose Li · City of Hope Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

79 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-23

Primary Completion

2028-04-09

Completion

2028-04-09

FDA Drug

Yes

Countries

• United States

Study Locations