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

Not Applicable

Not yet recruiting

• Conditions: Prostate Carcinoma; Recurrent Prostate Carcinoma
• Interventions: Drug: Antiandrogen Therapy; Procedure: Biospecimen Collection; Behavioral: Behavioral Intervention; 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; Other: Short-Term Fasting; Drug: Semaglutide; Drug: Tirzepatide

• Registration Number: NCT07202247
• Lead Sponsor: City of Hope Medical Center

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.

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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-18
• Study First Submitted QC: 2025-09-23
• Last Update Submitted: 2025-09-23
• Study First Posted: 2025-10-01
• Last Update Posted: 2025-10-01
• Study Start: 2025-12-08
• Primary Completion: 2027-06-28
• Study Completion: 2027-06-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1 (TRE)	Radiation Therapy	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.
Arm 1 (TRE)	Short-Term Fasting	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.
Arm 2 (semaglutide, tirzepatide)	Biospecimen Collection	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.
Arm 2 (semaglutide, tirzepatide)	Computed Tomography	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.
Arm 2 (semaglutide, tirzepatide)	Electronic Health Record Review	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.
Arm 2 (semaglutide, tirzepatide)	Internet-Based Intervention	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.
Arm 2 (semaglutide, tirzepatide)	Lifestyle Counseling	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.
Arm 2 (semaglutide, tirzepatide)	Radiation Therapy	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.
Arm 2 (semaglutide, tirzepatide)	Medical Device Usage and Evaluation	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.
Arm 2 (semaglutide, tirzepatide)	Nutritional Intervention	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.
Arm 2 (semaglutide, tirzepatide)	Questionnaire Administration	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.
Arm 2 (semaglutide, tirzepatide)	Referral	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.
Arm 2 (semaglutide, tirzepatide)	Semaglutide	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.
Arm 2 (semaglutide, tirzepatide)	Tirzepatide	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.
Arm 3 (AHA HDD)	Antiandrogen Therapy	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.
Arm 3 (AHA HDD)	Biospecimen Collection	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.
Arm 3 (AHA HDD)	Electronic Health Record Review	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.
Arm 3 (AHA HDD)	Cardiac Computerized Tomographic Angiography	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.
Arm 3 (AHA HDD)	Computed Tomography	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.
Arm 3 (AHA HDD)	Internet-Based Intervention	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.
Arm 3 (AHA HDD)	Nutritional Intervention	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.
Arm 3 (AHA HDD)	Lifestyle Counseling	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.
Arm 3 (AHA HDD)	Medical Device Usage and Evaluation	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.
Arm 3 (AHA HDD)	Questionnaire Administration	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.
Arm 3 (AHA HDD)	Radiation Therapy	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.
Arm 1 (TRE)	Antiandrogen Therapy	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.
Arm 1 (TRE)	Internet-Based Intervention	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.
Arm 1 (TRE)	Behavioral Intervention	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.
Arm 1 (TRE)	Biospecimen Collection	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.
Arm 1 (TRE)	Computed Tomography	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.
Arm 2 (semaglutide, tirzepatide)	Antiandrogen Therapy	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.
Arm 2 (semaglutide, tirzepatide)	Cardiac Computerized Tomographic Angiography	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.
Arm 1 (TRE)	Cardiac Computerized Tomographic Angiography	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.
Arm 1 (TRE)	Lifestyle Counseling	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.
Arm 1 (TRE)	Nutritional Intervention	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.
Arm 1 (TRE)	Electronic Health Record Review	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.
Arm 1 (TRE)	Medical Device Usage and Evaluation	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.
Arm 1 (TRE)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method
Changes in visceral adiposity	At completion of 6 months of ADT and at 12 months follow up after completion of ADT	Will be measured using computed tomography and bioelectrical impedance analysis.
Changes in muscle mass	At completion of 6 months of ADT and at 12 months follow up after completion of ADT	Will be measured using computed tomography and bioelectrical impedance analysis.
Percent of patients who successfully complete interventions	Up to 12 months after completion of ADT	Tolerability and feasibility will be defined as at least 70% of enrolled patients successfully completing the interventions for a minimum of 70% of the study duration.
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	The changes in the AHA PREVENT risk score will be compared between GLP1-RA vs. TRE interventions.
Incidence of de novo metabolic syndrome	At completion of 6 months of ADT and at 12 months follow up after completion of ADT
Quality of life - International Prognostic Scoring System	At baseline and up to 12 months after completion of ADT	Will be measured using the International Prognostic Scoring System.
Quality of life - Sexual Health Inventory for Men	At baseline and up to 12 months after completion of ADT	Will be measured using the Sexual Health Inventory for Men.
Quality of life - Merrick rectal function	At baseline and up to 12 months after completion of ADT	Will be measured using the Merrick rectal function.
Evidence of endothelial dysfunction	At completion of 6 months of ADT and at 12 months follow up after completion of ADT	Will be measured by flow mediated dilation of the brachial artery.
Quality of life - Patient Reported Outcomes Measurement Information System 29	At baseline and up to 12 months after completion of ADT	Will be measured using the Patient Reported Outcomes Measurement Information System 29.

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States