A Phase II Randomized Study of Interventions for Metabolic Protection Against Cardiometabolic Toxicity During Androgen Deprivation Therapy (IMPACT-ADT)
Condition: Prostate Carcinoma, Recurrent Prostate Carcinoma
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT07202247
Sponsor: City of Hope Medical Center
Phase: Phase 2
Eligibility:
- Age: minimum 30 Years maximum 79 Years
- Gender: Male
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)
View trial on ClinicalTrials.gov