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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT07202247
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
30 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • Antiandrogen Therapy — DRUG
    Given ADT
  • Behavioral Intervention — BEHAVIORAL
    Receive fasting reminders via Oncpatient Companion Mobile Application
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Cardiac Computerized Tomographic Angiography — PROCEDURE
    Undergo a coronary computerized tomography angiography
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Electronic Health Record Review — OTHER
    Ancillary studies
  • Internet-Based Intervention — OTHER
    Complete survey and food diary collection via Oncpatient Companion Mobile Application
  • Lifestyle Counseling — BEHAVIORAL
    Receive diet and lifestyle counseling
  • Medical Device Usage and Evaluation — OTHER
    Wear an activity tracker
  • Nutritional Intervention — OTHER
    Receive AHA HHD guidelines
  • Nutritional Intervention — OTHER
    Receive AHA Life Essential 8 recommendations with personalized caloric intake
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Radiation Therapy — RADIATION
    Undergo RT
  • Referral — OTHER
    Receive a referral to an endocrinologist
  • Semaglutide — DRUG
    Given SC
  • Short-Term Fasting — OTHER
    Participate in an overnight fast
  • Tirzepatide — DRUG
    Given SC

Study Details

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.

Key Dates

Start date
Jan 23, 2026
Status verified
Feb 2026
Primary completion
Apr 9, 2028
Completion
Apr 9, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Rose Li
[email protected]
508-864-7639
Rose Li (PRINCIPAL_INVESTIGATOR)

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By condition
Prostate cancer
By specialty
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By research site
City of Hope Medical Center· Duarte, CA

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