NCT07202247

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: Male
• Age: 30 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Detailed 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. EXPLORATORY OBJECTIVES: I. Define the impact of metabolic interventions, including TRE and GLP1 RA treatment, on ADT-induced metabolome-inflammasome dysfunction. II. Evaluate the impact of metabolic interventions, including TRE and GLP1 RA treatment, on clonal dynamics following ADT. III. Evaluate how metabolic interventions, including TRE and GLP1 RA treatment, impact coronary plaque characteristics in PCa patients undergoing ADT. OUTLINE: Patients are randomized to 1 of 3 arms. 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. Patients may may optionally wear an activity tracker throughout the trial. 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. 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. Patients may may optionally wear an activity tracker throughout the trial. ARM 3 (AHA HHD): Patients receive RT and ADT per SOC for 6 months. Patients receive diet/lifestyle counseling as per AHA HHD guidelines and AHA Life Essential 8 recommendations with personalized caloric intake for 6 months. Patients also receive dietary education and complete survey and food diary collection via the Oncpatient Companion Mobile app. Patients may may optionally wear an activity tracker throughout the trial. Additionally, patients undergo computed tomography (CT), blood sample collection throughout the study, and may optionally undergo a coronary computerized tomography angiography throughout the study. After completion of study intervention, patients are followed up at 30 days and at 12 months.

Conditions

• Prostate Carcinoma
• Recurrent Prostate Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-01-23
• Primary completion: 2028-04-09
• Completion: 2028-04-09
• First posted: 2025-10-01
• Last updated: 2026-02-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study