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Metabolic Interventions for Prostate Cancer Patients on ADT

This study, called IMPACT-ADT, is looking at ways to improve heart and metabolic health in men with prostate cancer who are receiving androgen deprivation therapy (ADT). ADT can increase the risk of heart problems. This trial will compare three approaches: time-restricted eating (TRE), medications like semaglutide and tirzepatide (GLP1 receptor agonists), and a heart-healthy diet based on American Heart Association guidelines. Researchers want to see if these interventions can reduce your 10-year risk of cardiovascular disease. You may be eligible if you are a man aged 30-79 with prostate cancer, are receiving ADT, and have existing heart-related health issues. The study aims to enroll 60 participants.

Study design
This is an interventional study, but the phase is not specified. It plans to enroll 60 participants.
What's involved
You would undergo blood sample collection, a coronary computerized tomography angiography, and a CT scan. If in the time-restricted eating group, you would receive fasting reminders via a mobile app for 6 months.
Compensation
Not stated in the trial record.
Follow-up
Your cardiovascular disease risk will be measured at the end of 6 months of ADT and again 12 months after ADT completion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
PHASE2Ages 30–79InterventionalPrevention
City of Hope Medical Center
~60 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:Antiandrogen TherapyBehavioral InterventionBiospecimen CollectionCardiac Computerized Tomographic AngiographyComputed TomographyElectronic Health Record Review

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in the 10-year risk of cardiovascular disease
Measured over At completion of 6 months of androgen deprivation therapy (ADT) and at 12 months follow up after completion of ADT
+1 more outcome measured

Conditions

Prostate Carcinoma
Recurrent Prostate Carcinoma

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Rose Li · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Rose Li
[email protected]
508-864-7639
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Changes in the 10-year risk of cardiovascular diseaseAt completion of 6 months of androgen deprivation therapy (ADT) and at 12 months follow up after completion of ADT

    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.

  • Changes in the 10-year risk of cardiovascular diseaseAt 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.