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
- Status
- RecruitingResults none
- Why it is watched
- non-weight indication: cardiovascular, cancer
- Who it enrolls
- age 30 Years to 79 Years; male; excludes diabetes; BMI ≥30 required; conditions: Prostate Carcinoma; Recurrent Prostate Carcinoma
- Interventions
- Antiandrogen Therapy; Behavioral Intervention; Biospecimen Collection; Cardiac Computerized Tomographic Angiography; Computed Tomography; Electronic Health Record Review; Internet-Based Intervention; Lifestyle Counseling; Medical Device Usage and Evaluation; Nutritional Intervention; Nutritional Intervention; Questionnaire Administration; Radiation Therapy; Referral; Semaglutide; Short-Term Fasting; Tirzepatide
- Conditions
- Prostate Carcinoma; Recurrent Prostate Carcinoma
- Phase and size
- Phase 2 · 60 participants
- Dates
- Start 2025-11-05
Primary completion 2028-04-09 - Sponsor
- City of Hope Medical Center (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- 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
- 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
02Eligibility
Who can take part
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)
03Change log
Registry changes
No changes recorded since the trial was added.