BridgeMD
New treatment option for Prostate Carcinoma
Official title 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
ClinicalTrials.gov ID: NCT07202247
What this study is testing
What is Antiandrogen Therapy?
Antiandrogen Therapy is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for prostate carcinoma.
Also referred to as ADT, Androgen Deprivation Therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 79, men only
You may be able to join if
- 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
You likely can't join if
- 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...
- Other active disease deemed not eligible to participant in the study according to treating physician
See the full eligibility 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
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 30 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.