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

NCT07202247 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 25332NCI-2025-06197P30CA033572
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Changes in the 10-year risk of cardiovascular disease

  The changes in the American Heart Association Predicting Risk of cardiovascular disease (CVD) EVENTs (AHA PREVENT) risk score will be compared between glucagon-like peptide-1 receptor agonist (GLP1-RA) versus (vs.) AHA heart healthy diet (AHA HHD) interventions using a 2-group t-test with a 0.050 one-sided significance level.

  At completion of 6 months of androgen deprivation therapy (ADT) and at 12 months follow up after completion of ADT

• Changes in the 10-year risk of cardiovascular disease

  The changes in the AHA PREVENT risk score will be compared between time-restricted eating (TRE) vs. AHA HHD interventions using a 2-group t-test with a 0.050 one-sided significance level.

  At completion of 6 months of ADT and at 12 months follow up after completion of ADT

Secondary Outcomes (10)

• Changes in the 10-year risk of cardiovascular disease

  At completion of 6 months of ADT and at 12 months follow up after completion of ADT

• Incidence of de novo metabolic syndrome

  At completion of 6 months of ADT and at 12 months follow up after completion of ADT

• Changes in visceral adiposity

  At completion of 6 months of ADT and at 12 months follow up after completion of ADT

• Changes in muscle mass

  At completion of 6 months of ADT and at 12 months follow up after completion of ADT

• Evidence of endothelial dysfunction

  At completion of 6 months of ADT and at 12 months follow up after completion of ADT

Study Arms (3)

Arm 1 (TRE)

EXPERIMENTAL

Patients receive RT and ADT per 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 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. Additionally, patients undergo CT, blood sample collection throughout the study and may optionally undergo a coronary computerized tomography angiography throughout the study.

Drug: Antiandrogen Therapy; Behavioral: Behavioral Intervention; Procedure: Biospecimen Collection; Procedure: Cardiac Computerized Tomographic Angiography; Procedure: Computed Tomography; Other: Electronic Health Record Review; Other: Internet-Based Intervention; Behavioral: Lifestyle Counseling; Other: Medical Device Usage and Evaluation; Other: Nutritional Intervention; Other: Questionnaire Administration; Radiation: Radiation Therapy; Other: Short-Term Fasting

Arm 2 (semaglutide, tirzepatide)

EXPERIMENTAL

Patients receive RT and ADT per SOC for 6 months. Patients receive a referral to an endocrinologist and receive semaglutide or tirzepatide SC 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. Additionally, patients undergo CT, blood sample collection throughout the study and may optionally undergo a coronary computerized tomography angiography throughout the study.

Drug: Antiandrogen Therapy; Procedure: Biospecimen Collection; Procedure: Cardiac Computerized Tomographic Angiography; Procedure: Computed Tomography; Other: Electronic Health Record Review; Other: Internet-Based Intervention; Behavioral: Lifestyle Counseling; Other: Medical Device Usage and Evaluation; Other: Nutritional Intervention; Other: Questionnaire Administration; Radiation: Radiation Therapy; Other: Referral; Drug: Semaglutide; Drug: Tirzepatide

Arm 3 (AHA HDD)

ACTIVE COMPARATOR

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 CT, blood sample collection throughout the study and may optionally undergo a coronary computerized tomography angiography throughout the study.

Drug: Antiandrogen Therapy; Procedure: Biospecimen Collection; Procedure: Cardiac Computerized Tomographic Angiography; Procedure: Computed Tomography; Other: Electronic Health Record Review; Other: Internet-Based Intervention; Behavioral: Lifestyle Counseling; Other: Medical Device Usage and Evaluation; Other: Nutritional Intervention; Other: Questionnaire Administration; Radiation: Radiation Therapy

Interventions

Antiandrogen Therapy DRUG

Given ADT

Also known as: ADT, Androgen Deprivation Therapy, Androgen Deprivation Therapy (ADT), Anti-androgen Therapy, Anti-androgen Treatment, Antiandrogen Treatment, Hormone Deprivation Therapy, Hormone-Deprivation Therapy

Arm 1 (TRE); Arm 2 (semaglutide, tirzepatide); Arm 3 (AHA HDD)

Behavioral Intervention BEHAVIORAL

Receive fasting reminders via Oncpatient Companion Mobile Application

Also known as: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments

Arm 1 (TRE)

Short-Term Fasting OTHER

Participate in an overnight fast

Also known as: Intermittent Fasting, Short-term Intermittent Fasting

Arm 1 (TRE)

Tirzepatide DRUG

Given SC

Arm 2 (semaglutide, tirzepatide)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm 1 (TRE); Arm 2 (semaglutide, tirzepatide); Arm 3 (AHA HDD)

Cardiac Computerized Tomographic Angiography PROCEDURE

Undergo a coronary computerized tomography angiography

Arm 1 (TRE); Arm 2 (semaglutide, tirzepatide); Arm 3 (AHA HDD)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

Arm 1 (TRE); Arm 2 (semaglutide, tirzepatide); Arm 3 (AHA HDD)

Electronic Health Record Review OTHER

Ancillary studies

Arm 1 (TRE); Arm 2 (semaglutide, tirzepatide); Arm 3 (AHA HDD)

Internet-Based Intervention OTHER

Complete survey and food diary collection via Oncpatient Companion Mobile Application

Arm 1 (TRE); Arm 2 (semaglutide, tirzepatide); Arm 3 (AHA HDD)

Lifestyle Counseling BEHAVIORAL

Receive diet and lifestyle counseling

Arm 1 (TRE); Arm 2 (semaglutide, tirzepatide); Arm 3 (AHA HDD)

Medical Device Usage and Evaluation OTHER

Wear an activity tracker

Arm 1 (TRE); Arm 2 (semaglutide, tirzepatide); Arm 3 (AHA HDD)

Nutritional Intervention OTHER

Receive AHA HHD guidelines

Arm 1 (TRE); Arm 2 (semaglutide, tirzepatide); Arm 3 (AHA HDD)

Questionnaire Administration OTHER

Ancillary studies

Arm 1 (TRE); Arm 2 (semaglutide, tirzepatide); Arm 3 (AHA HDD)

Radiation Therapy RADIATION

Undergo RT

Also known as: Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

Arm 1 (TRE); Arm 2 (semaglutide, tirzepatide); Arm 3 (AHA HDD)

Semaglutide DRUG

Given SC

Also known as: Ozempic, Rybelsus, Wegovy

Arm 2 (semaglutide, tirzepatide)

Referral OTHER

Receive a referral to an endocrinologist

Also known as: Referred

Arm 2 (semaglutide, tirzepatide)

Eligibility Criteria

• Age: 30 Years - 79 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• City of Hope Medical Center: lead

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Androgen Antagonists; Behavior Therapy; Specimen Handling; Radiotherapy; Radiation; Referral and Consultation; semaglutide; Tirzepatide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Psychotherapy; Behavioral Disciplines and Activities; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Therapeutics; Physical Phenomena; Professional Practice; Organization and Administration; Health Services Administration; Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• Rose Li

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: October 1, 2025
• Study Start: January 23, 2026
• Primary Completion (Estimated): April 9, 2028
• Study Completion (Estimated): April 9, 2028
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

US (1)