LivingGLP1
Study S000779

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

Registration

Registration
NCT07202247
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE2
Masking
NONE
Status
RECRUITING
Enrollment
60
Start
2025-11-05
Primary completion
2028-04-09
Lead sponsor
City of Hope Medical Center
Conditions
Prostate Carcinoma; Recurrent Prostate Carcinoma
Interventions
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:Referral; DRUG:Semaglutide; OTHER:Short-Term Fasting; DRUG:Tirzepatide
Results posted
FALSE
Secondary identifiers
REGISTRY:NCI-2025-06197; OTHER:25332; NIH:P30CA033572

Registered primary outcomes

  • Changes in the 10-year risk of cardiovascular disease [At 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 disease [At completion of 6 months of ADT and at 12 months follow up after completion of ADT]

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