Metabolic Interventions for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: City of Hope Medical Center

Must not be taking: GLP1-RAs

Disqualifiers: Strict diets, Poorly controlled diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 30

Duration: 6 months

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different methods to improve heart and metabolic health in prostate cancer patients undergoing hormone therapy. It examines time-restricted eating (intermittent fasting), medications like semaglutide and tirzepatide (which aid in blood sugar and weight management), and a heart-healthy diet. The goal is to determine which method better prevents heart issues and aids in energy management. Men with prostate cancer on hormone therapy, who are at high risk of heart problems and may benefit from weight management, are well-suited for this study. As a Phase 2 trial, this research measures the effectiveness of these treatments in an initial, smaller group, allowing participants to contribute to significant advancements in care.

Do I need to stop taking my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are currently on GLP1-RA therapy, you cannot participate in the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that semaglutide and tirzepatide, medications that help control blood sugar, are generally safe. Studies have found that these drugs do not increase cancer risk. They are already used to treat diabetes and aid in weight loss, indicating good tolerance among many people.

Time-restricted eating (TRE), which involves eating only during certain hours each day, has shown potential to improve quality of life, and people tend to adhere to it. It might also enhance the effectiveness of cancer treatments. Current research does not report major safety concerns with TRE.

Both treatment options have been tested in other studies and have shown safety. However, since this trial is in Phase 2, researchers are still studying these treatments to confirm their safety and effectiveness for prostate cancer patients on hormone therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the use of semaglutide and tirzepatide for prostate cancer because, unlike traditional hormone therapies and radiation, these drugs are originally designed for managing diabetes and obesity. They work by mimicking hormones that regulate insulin and appetite, which could potentially help manage metabolic changes in cancer patients. This is a novel approach because it targets the metabolic aspects of the disease, offering a fresh angle in treating prostate cancer. Additionally, these drugs are administered via a weekly injection, which may provide a more convenient alternative to daily treatments.

What evidence suggests that this trial's treatments could be effective for prostate cancer patients undergoing ADT?

This trial will evaluate different metabolic interventions for prostate cancer. One arm involves medications like semaglutide and tirzepatide. Studies have shown these can lower prostate cancer risk by improving insulin use, reducing blood sugar levels, and potentially leading to weight loss. Researchers have observed these medications slowing cancer cell growth and enhancing the body's energy use. Another arm will assess time-restricted eating (TRE), which involves eating only during certain hours. TRE has shown promise in improving metabolism and reducing tumor growth in prostate cancer studies. Both approaches aim to counteract the negative effects of prostate cancer treatments on the body's metabolism. ^{2 5 6 7 8}

Who Is on the Research Team?

Rose Li

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for prostate cancer patients on androgen deprivation therapy at risk of cardiovascular disease. It tests if time-restricted eating and GLP1 receptor agonists (semaglutide, tirzepatide) are more effective than a heart-healthy diet alone in improving heart and metabolic health.

Inclusion Criteria

Documented informed consent of the participant

Agreement to allow the use of archival tissue from diagnostic tumor biopsies. Exceptions may be granted with study principal investigator (PI) approval if unavailable

I am overweight with a BMI of 30 or more, or have a BMI of 27 or more with conditions like high blood pressure or type 2 diabetes.

Exclusion Criteria

Currently engaging in strict macronutrient/time limited diet, including ketogenic, low-carb, paleo, or warrior diet

Unable to undergo time-restricted diet

Other active disease deemed not eligible to participant in the study according to treating physician

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive radiation therapy and androgen deprivation therapy per standard of care, with additional interventions based on randomization: time-restricted eating, GLP1 receptor agonist, or heart healthy diet for 6 months

6 months

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of cardiovascular and metabolic health

12 months

Follow-up visits at 30 days and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Semaglutide
• Time-Restricted Eating
• Tirzepatide

Trial Overview The IMPACT-ADT trial compares the effects of intermittent fasting (time-restricted eating), GLP1 receptor agonists (semaglutide, tirzepatide), and an American Heart Association recommended diet on cardiovascular and metabolic systems in prostate cancer patients undergoing hormonal therapy.

How Is the Trial Designed?

Group I: Arm 2 (semaglutide, tirzepatide) Experimental Treatment 14 Interventions

Patients receive RT and ADT per SOC for 6 months. Patients receive a referral to an endocrinologist and receive semaglutide or tirzepatide SC QW for 6 months in the absence of disease progression or unacceptable toxicity. Patients also receive dietary education and complete survey and food diary collection via the Oncpatient Companion Mobile app. In addition, patients receive diet/lifestyle counseling as per AHA HHD guidelines and AHA Life Essential 8 recommendations with personalized caloric intake for 6 months. Patients may may optionally wear an activity tracker throughout the trial. Additionally, patients undergo CT, blood sample collection throughout the study and may optionally undergo a coronary computerized tomography angiography throughout the study.

Group II: Arm 1 (TRE) Experimental Treatment 13 Interventions

Patients receive RT and ADT per SOC, as well as participate in an overnight fast over 16 hours on at least 5 days weekly for 6 months. Patients also receive TRE reminders, dietary education, and complete survey and food diary collection via the Oncpatient Companion Mobile app. In addition, patients receive diet/lifestyle counseling as per AHA HHD guidelines and AHA Life Essential 8 recommendations with personalized caloric intake for 6 months. Patients may may optionally wear an activity tracker throughout the trial. Additionally, patients undergo CT, blood sample collection throughout the study and may optionally undergo a coronary computerized tomography angiography throughout the study.

Group III: Arm 3 (AHA HDD) Active Control 11 Interventions

Patients receive RT and ADT per SOC for 6 months. Patients receive diet/lifestyle counseling as per AHA HHD guidelines and AHA Life Essential 8 recommendations with personalized caloric intake for 6 months. Patients also receive dietary education and complete survey and food diary collection via the Oncpatient Companion Mobile app. Patients may may optionally wear an activity tracker throughout the trial. Additionally, patients undergo CT, blood sample collection throughout the study and may optionally undergo a coronary computerized tomography angiography throughout the study.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11479428/

Effect of glucagon-like peptide-1 receptor agonists on prostate ... Several clinical studies have shown a reduced risk of prostate cancer with the use of GLP-1 receptor agonists (GLP-1RAs). In a nationwide cohort study by ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.182

GLP1R expression in prostate cancer patients and effects ... Semaglutide treatment in pre-clinical prostate cancer models resulted in decreased cell proliferation, decreased glycolytic function, and ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090429525004261

GLP-1 Agonist Use Among Men With Localized Prostate ... Epidemiologic data suggest that prostate cancer risk may decrease following GLP-1 receptor agonist initiation.

4. jci.org jci.org/articles/view/194743

GLP-1 receptor agonists and cancer: current clinical ... In preclinical thyroid cancer models (47), semaglutide was shown to have tumor-suppressive effects through actions on immune cells. Semaglutide ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06759701

NCT06759701 | Pre-Surgical Tirzepatide-Assisted Weight ... The goal of this clinical research study is to determine how well a tirzepatide-assisted weight loss program works before a prostatectomy in patients with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11898313/

Tirzepatide and Cancer Risk in Individuals with and without ... Effect of tirzepatide on the primary outcome: risk of any cancer. Overall, tirzepatide use was associated with a similar risk of any cancer to the pooled ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1871402123001303

Semaglutide and cancer: A systematic review and meta- ... Conclusion. Semaglutide use in RCTs and real-world studies was not associated with an increased risk of any types of cancer, and this conclusion is supported ...

8. uspharmacist.com uspharmacist.com/article/incretinbased-pharmacotherapy-for-reducing-prostate-cancer-risk

Incretin-Based Pharmacotherapy for Reducing Prostate ... ABSTRACT: Despite relatively low mortality, prostate cancer (PCa) survivability decreases substantially with metastasis. Conventional treatment ...