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?

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 intermediate risk prostate cancer

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.

How does the drug Tirzepatide differ from other treatments for prostate cancer?

Tirzepatide is unique because it is primarily known for its use in managing type 2 diabetes and obesity, working by mimicking hormones that regulate insulin and appetite, which is different from traditional prostate cancer treatments like chemotherapy or hormone therapy that target cancer cells directly. ^{1 2 3 4 5}

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

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]

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]

Citations

1. Netherlands 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. [2022]

2. Israel pubmed.ncbi.nlm.nih.gov

[Taxotere-based chemotherapy in androgen-independent prostate cancer]. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Is there a role for chemotherapy in prostate cancer? [2022]

4. France pubmed.ncbi.nlm.nih.gov

[Chemotherapy in castrate-resistant metastatic prostate cancer]. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

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