Recruiting
Phase 2

TRE & GLP1-RA

Sponsor:

City of Hope Medical Center

Code:

NCT07202247

Conditions

Prostate Carcinoma

Recurrent Prostate Carcinoma

Eligibility Criteria

Sex: Male

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Antiandrogen Therapy

Behavioral Intervention

Biospecimen Collection

Cardiac Computerized Tomographic Angiography

Computed Tomography

Study Details

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

Study ID

NCT07202247

Start date

Nov 5, 2025

Status verified date

Aug, 2026

Completion date

Apr 9, 2028

Anticipated

Primary completion date

Apr 9, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 30 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Arm 1 (TRE)

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.

experimental: Arm 2 (semaglutide, 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.

active comparator: Arm 3 (AHA HDD)

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.

Interventions

Antiandrogen Therapy

Given ADT

Behavioral Intervention

Receive fasting reminders via Oncpatient Companion Mobile Application

Biospecimen Collection

Undergo blood sample collection

Cardiac Computerized Tomographic Angiography

Undergo a coronary computerized tomography angiography

Computed Tomography

Undergo CT

Electronic Health Record Review

Ancillary studies

Internet-Based Intervention

Complete survey and food diary collection via Oncpatient Companion Mobile Application

Lifestyle Counseling

Receive diet and lifestyle counseling

Medical Device Usage and Evaluation

Wear an activity tracker

Nutritional Intervention

Receive AHA HHD guidelines

Nutritional Intervention

Receive AHA Life Essential 8 recommendations with personalized caloric intake

Questionnaire Administration

Ancillary studies

Radiation Therapy

Undergo RT

Referral

Receive a referral to an endocrinologist

Semaglutide

Given SC

Short-Term Fasting

Participate in an overnight fast

Tirzepatide

Given SC

Primary outcome measure

  • Changes in the 10-year risk of cardiovascular disease [ Time Frame: 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 [ Time Frame: At completion of 6 months of ADT and at 12 months follow up after completion of ADT ]

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Rose Li

508-864-7639yunroseli@coh.org

Principal Investigator:

Rose Li

More Information

Sponsor

City of Hope Medical Center

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-08-17.