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Prostate CarcinomaPhase 2NCT07202247

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

A Phase 2 study testing Antiandrogen Therapy, Behavioral Intervention and Biospecimen Collection in people with Prostate Carcinoma and Recurrent Prostate Carcinoma, run by City of Hope Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 30 to 79 years, men only
What is being tested?
Antiandrogen Therapy, Behavioral Intervention and Biospecimen Collection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
5 Nov 2025to 9 Apr 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 79 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • City of Hope Medical Center

    Duarte, California, 91010

    Rose Li, 508-864-7639, yunroseli@coh.org

    Rose Li

    Recruiting

Other trials in United States

About this study

Official title: A Phase II Randomized Study of Interventions for Metabolic Protection Against Cardiometabolic Toxicity During Androgen Deprivation Therapy (IMPACT-ADT)

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Evaluate whether metabolic interventions, including TRE and GLP1-RA treatment, improve the cardiometabolic health of prostate cancer (PCa) patients undergoing ADT.

SECONDARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
Antiandrogen Therapy, Behavioral Intervention, Biospecimen Collection, Cardiac Computerized Tomographic Angiography, Computed Tomography
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Antiandrogen TherapyDrug

    Also called ADT, Androgen Deprivation Therapy, Androgen Deprivation Therapy (ADT), Anti-androgen Therapy

    Given ADT

  • Behavioral InterventionBehavioural

    Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy

    Receive fasting reminders via Oncpatient Companion Mobile Application

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Cardiac Computerized Tomographic AngiographyProcedure or surgery

    Undergo a coronary computerized tomography angiography

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • Electronic Health Record ReviewOther

    Ancillary studies

  • Internet-Based InterventionOther

    Complete survey and food diary collection via Oncpatient Companion Mobile Application

  • Lifestyle CounselingBehavioural

    Receive diet and lifestyle counseling

  • Medical Device Usage and EvaluationOther

    Wear an activity tracker

  • Nutritional InterventionOther

    Receive AHA HHD guidelines

  • Nutritional InterventionOther

    Receive AHA Life Essential 8 recommendations with personalized caloric intake

  • Questionnaire AdministrationOther

    Ancillary studies

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate

    Undergo RT

  • ReferralOther

    Also called Referred

    Receive a referral to an endocrinologist

  • SemaglutideDrug

    Also called Ozempic, Rybelsus, Wegovy

    Given SC

  • Short-Term FastingOther

    Also called Intermittent Fasting, Short-term Intermittent Fasting

    Participate in an overnight fast

  • TirzepatideDrug

    Given SC

Study groups in NCT07202247
Study groupRoleWhat they receive
Arm 1 (TRE)ExperimentalPatients 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.
Receives: 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)ExperimentalPatients 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.
Receives: 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 comparatorPatients 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (10)

  1. Changes in the 10-year risk of cardiovascular disease

    The changes in the AHA PREVENT risk score will be compared between GLP1-RA vs. TRE interventions.

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

  2. Incidence of de novo metabolic syndrome

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

  3. Changes in visceral adiposity

    Will be measured using computed tomography and bioelectrical impedance analysis.

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

  4. Changes in muscle mass

    Will be measured using computed tomography and bioelectrical impedance analysis.

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

  5. Evidence of endothelial dysfunction

    Will be measured by flow mediated dilation of the brachial artery.

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

  6. Percent of patients who successfully complete interventions

    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.

    Measured: Up to 12 months after completion of ADT

  7. Quality of life - International Prognostic Scoring System

    Will be measured using the International Prognostic Scoring System.

    Measured: At baseline and up to 12 months after completion of ADT

  8. Quality of life - Sexual Health Inventory for Men

    Will be measured using the Sexual Health Inventory for Men.

    Measured: At baseline and up to 12 months after completion of ADT

  9. Quality of life - Merrick rectal function

    Will be measured using the Merrick rectal function.

    Measured: At baseline and up to 12 months after completion of ADT

  10. Quality of life - Patient Reported Outcomes Measurement Information System 29

    Will be measured using the Patient Reported Outcomes Measurement Information System 29.

    Measured: At baseline and up to 12 months after completion of ADT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2025
  2. Study start5 Nov 2025
  3. Primary completion9 Apr 2028 (estimated)
  4. Study completion9 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07202247
Sponsor's protocol ID
25332
Other IDs
NCI-2025-06197, 25332, P30CA033572
Status last verified
Aug 2026
First submitted
18 Sep 2025
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Antiandrogen Therapy, Behavioral Intervention and Biospecimen Collection in people with Prostate Carcinoma and Recurrent Prostate Carcinoma, run by City of Hope Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07202247.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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