Status:
RECRUITING
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
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Carcinoma
Recurrent Prostate Carcinoma
Eligibility:
MALE
30-79 years
Phase:
PHASE2
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) h...
Detailed Description
PRIMARY OBJECTIVE: I. Evaluate whether metabolic interventions, including TRE and GLP1-RA treatment, improve the cardiometabolic health of prostate cancer (PCa) patients undergoing ADT. SECONDARY OB...
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)
Key Trial Info
Start Date :
December 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 9 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07202247
Start Date
December 8 2025
End Date
April 9 2028
Last Update
October 14 2025
Active Locations (1)
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1
City of Hope Medical Center
Duarte, California, United States, 91010