Tirzepatide for Prostate Cancer

Overseen By Justin Gregg, MD

Age: 18+

Sex: Male

Trial Phase: Phase < 1

Sponsor: M.D. Anderson Cancer Center

Must be taking: GLP-1R agonists

Must not be taking: Weight loss drugs

Disqualifiers: Metastatic disease, Renal impairment, Psychiatric disorders, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 1 year

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a weight loss program using tirzepatide, a medication for weight management, can assist patients with intermediate-risk prostate cancer before prostate removal surgery. Researchers are testing tirzepatide to evaluate its effectiveness in supporting weight loss in these patients. The study seeks men with localized prostate cancer who are considering surgery and have diabetes with a BMI of 27 or higher, or a waist size over 40 inches. Participants should also have conditions such as high blood pressure, high cholesterol, sleep apnea, or heart disease. As an Early Phase 1 trial, this research focuses on understanding tirzepatide's effects in people, offering participants an opportunity to contribute to groundbreaking medical knowledge.

Do I need to stop taking my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it does mention that participants should not be on medications that promote weight loss or certain psychiatric medications. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that tirzepatide is likely to be safe for humans?

Research has shown that tirzepatide is generally safe for people. In earlier studies, participants taking tirzepatide lost weight without an increased cancer risk. Another study found that people using GLP-1 receptor agonists, the drug group that includes tirzepatide, had a lower risk of certain cancers, such as prostate cancer. While side effects can occur, tirzepatide has been safely used for other conditions, including diabetes and weight control. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Tirzepatide is unique because it offers a novel approach to treating prostate cancer by targeting both the GLP-1 and GIP receptors, which are not the typical targets of existing treatments. Most current prostate cancer therapies, like hormone therapies and chemotherapy, focus on reducing or blocking male hormones or killing rapidly dividing cells. Researchers are excited about tirzepatide because it represents a new mechanism of action that might offer additional benefits, such as improved metabolic effects, which could potentially enhance the overall health and treatment outcomes for patients with prostate cancer.

What evidence suggests that tirzepatide might be an effective treatment for prostate cancer?

Research has shown that tirzepatide, a medication often used for weight loss, might help reduce the risk of prostate cancer. Studies suggest that drugs like tirzepatide, known as GLP-1 receptor agonists, could lower the chance of developing prostate cancer. So far, evidence does not indicate that tirzepatide increases cancer risk, but its specific effects on prostate cancer remain under investigation. Early results suggest that the weight loss and body changes caused by tirzepatide might help lower cancer risk, but more research is needed to confirm this. Participants in this trial will receive tirzepatide to further investigate its potential benefits for prostate cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Justin Gregg, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for men who have both diabetes and intermediate-risk prostate cancer, are scheduled for a prostatectomy (surgery to remove the prostate), and need to lose weight before surgery. Specific details about eligibility criteria were not provided.

Inclusion Criteria

My prostate cancer is confirmed, localized, and considered intermediate risk.

My BMI is 27 or higher, or my waist is over 40 inches.

I am willing and able to follow the study's procedures and self-inject medication.

Exclusion Criteria

I have had treatments like hormone therapy, chemo, surgery, or radiation for prostate cancer.

I have a history of pancreatitis.

I haven't had severe depression or serious mental health issues in the last 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a tirzepatide-assisted weight loss program prior to radical prostatectomy

Up to 1 year

Surgery

Participants undergo radical prostatectomy after the weight loss program

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tirzepatide

Trial Overview The study is testing whether Tirzepatide can help these patients lose weight effectively before their surgery. It's a pilot feasibility study, which means it's an early test to see if this approach could work well.

How Is the Trial Designed?

Group I: Tirzepatide Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

Chemotherapy with mitoxantrone and prednisone can provide palliative benefits for patients with symptomatic hormone-refractory prostate cancer and is generally well tolerated, even in elderly patients, although its use is limited by potential cardiotoxicity.

Docetaxel and paclitaxel may offer higher rates of prostate-specific antigen response compared to mitoxantrone, but they come with increased toxicity, and large phase III trials are underway to compare their effectiveness directly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there a role for chemotherapy in prostate cancer? Canil, CM., Tannock, IF.[2022]

Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is an approved treatment for adult patients with advanced prostate cancer that expresses the prostate-specific membrane antigen (PSMA).

This therapy is specifically indicated for patients who have already undergone treatment with androgen receptor pathway inhibitors and taxane-based chemotherapy, highlighting its role in later-stage cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Drug for Metastatic Castration-Resistant Prostate Cancer. Aschenbrenner, DS.[2022]

In the SPARTAN study involving 1207 patients with nonmetastatic castration-resistant prostate cancer, apalutamide significantly improved health-related quality of life (HRQoL) compared to placebo, with patients maintaining better scores over time.

Patients receiving apalutamide experienced minimal side effects and reported no worsening of fatigue, while those on placebo showed a decline in quality of life after about one year, highlighting the efficacy and tolerability of apalutamide in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health-related Quality of Life at the SPARTAN Final Analysis of Apalutamide for Nonmetastatic Castration-resistant Prostate Cancer Patients Receiving Androgen Deprivation Therapy. Oudard, S., Hadaschik, B., Saad, F., et al.[2022]

Citations

1. 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 ...

2. e-enm.org e-enm.org/journal/view.php?number=2572

Tirzepatide and Cancer Risk in Individuals with and without ... A recent meta-analysis, which included data from 37 RCTs and 19 real-world studies, reported no increased risk of any cancer with semaglutide ...

3. 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 ...

4. 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.

5. 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 ...

6. nature.com nature.com/articles/s41591-023-02597-w

Tirzepatide after intensive lifestyle intervention in adults ... Tirzepatide provided substantial additional reduction in body weight in participants who had achieved ≥5.0% weight reduction with intensive lifestyle ...

7. mdpi.com mdpi.com/2072-6694/17/9/1576

May Patients Receiving GLP-1 Agonists Be at Lower Risk ... The results of Wang et al. [11] showed that GLP-1 receptor agonist treatment is associated with decreased risks of several cancers (e.g., prostate, lung, and ...