Semaglutide for Prostate Cancer

(GAINPCCONTROL Trial)

Overseen By Steven Agapay, BSc

Age: 18+

Sex: Male

Trial Phase: Phase 4

Sponsor: Hamilton Health Sciences Corporation

Must be taking: Androgen deprivation therapy

Must not be taking: GLP-1 receptor agonists

Disqualifiers: Type 1 diabetes, Pancreatitis, 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: 1

Duration: 6 months

20 Participants Needed

Trial Summary

What is the purpose of this trial?

GAIN PC CONTROL is a study investigating Glucagon-Like Peptide-1 Receptor Agonists in men with prostate cancer who are being treated with androgen deprivation therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are already taking a GLP-1 RA (a type of medication for diabetes).

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

Semaglutide is unique for prostate cancer treatment as it is primarily known for managing type 2 diabetes and obesity by mimicking a hormone that regulates appetite and insulin. Unlike traditional prostate cancer treatments that target specific cancer markers or use radiolabeled agents, Semaglutide's mechanism involves metabolic pathways, which could offer a novel approach if proven effective for prostate cancer. ^{1 2 3 4 5}

Research Team

Darryl Leong, MBBs,MPH,PhD,FRACP,FESC

Principal Investigator

Population Health Research Institute and McMaster University

Jehonathan Pinthus, MD,FRCS(C),PhD

Principal Investigator

Juravinski Cancer Centre

Eligibility Criteria

Men with prostate cancer undergoing androgen deprivation therapy can join this trial. They must have a physician's diagnosis, be overweight (BMI ≥30 or ≥27 with certain conditions like hypertension), and not have type 1 diabetes, thyroid cancer history, pancreatitis, or multiple endocrine neoplasia type 2.

Inclusion Criteria

I have been diagnosed with pancreatic cancer by a doctor.

I am undergoing or will undergo hormone therapy for my cancer.

My BMI is high and I may have hypertension, diabetes, sleep apnea, or high cholesterol.

Exclusion Criteria

I or my family have a history of thyroid cancer.

I have Type 1 diabetes.

I am currently taking a GLP-1 receptor agonist medication.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive semaglutide with dose escalation over 6 months

6 months

Baseline visit, 1-month telephone follow-up, 3-month visit, 6-month close-out visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Semaglutide

Trial Overview The GAIN PC CONTROL study is testing the effects of Semaglutide Pen Injector on men with prostate cancer who are receiving hormone treatments to lower testosterone levels. The focus is on how this medication impacts their condition.

Participant Groups

Group I: Semaglutide Experimental Treatment 1 Intervention

The semaglutide dose will be 0.25mg subcutaneously once weekly for weeks 1-4, then 0.5mg once weekly for weeks 5-8, then 1mg once weekly for weeks 9-12, then 1.7mg once weekly for weeks 13-16, and then 2.4mg for the remainder of the trial. Semaglutide dose may be decreased in the case of adverse events to the highest tolerated dose.

Who Is Running the Clinical Trial?

Hamilton Health Sciences Corporation

Lead Sponsor

Trials

380

Recruited

345,000+

McMaster University

Collaborator

Trials

936

Recruited

2,630,000+

Findings from Research

A novel gastrin-releasing peptide receptor (GRPR) ligand, AMTG, shows promise for detecting and treating prostate cancer, especially in patients with PSMA-negative lesions, demonstrating high GRPR affinity and favorable biodistribution in preclinical studies.

In a proof-of-concept study, the 68Ga-labeled AMTG showed intense uptake in metastatic lesions in a patient with castration-resistant prostate cancer, indicating its potential for effective theranostic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical Comparison of the 64Cu- and 68Ga-Labeled GRPR-Targeted Compounds RM2 and AMTG, as Well as First-in-Humans [68Ga]Ga-AMTG PET/CT. Koller, L., Joksch, M., Schwarzenböck, S., et al.[2023]

In a study of 24 patients with primary prostate cancer, Ga-PSMA-11 PET/CT demonstrated a high detection rate of 95.8%, confirming its effectiveness in identifying cancerous lesions.

Dynamic PET/CT imaging showed that Ga-PSMA-11 accumulation in prostate cancer lesions increased over time, suggesting its potential for enhancing treatment strategies targeting PSMA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-PSMA-11 Dynamic PET/CT Imaging in Primary Prostate Cancer. Sachpekidis, C., Kopka, K., Eder, M., et al.[2022]

The ENZA-p trial is investigating the safety and efficacy of combining lutetium-177 (177 Lu)-PSMA-617 with enzalutamide in men with metastatic castration-resistant prostate cancer (mCRPC), aiming to improve prostate-specific antigen (PSA) progression-free survival (PFS) in high-risk patients.

This phase 2 trial will enroll 160 participants and assess various outcomes, including overall survival and quality of life, while also identifying potential biomarkers to personalize treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ENZA-p trial protocol: a randomized phase II trial using prostate-specific membrane antigen as a therapeutic target and prognostic indicator in men with metastatic castration-resistant prostate cancer treated with enzalutamide (ANZUP 1901). Emmett, L., Subramaniam, S., Joshua, AM., et al.[2022]

References

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

Radiolabeled enzyme inhibitors and binding agents targeting PSMA: Effective theranostic tools for imaging and therapy of prostate cancer. [2018]

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

Preclinical Comparison of the 64Cu- and 68Ga-Labeled GRPR-Targeted Compounds RM2 and AMTG, as Well as First-in-Humans [68Ga]Ga-AMTG PET/CT. [2023]

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

68Ga-PSMA-11 Dynamic PET/CT Imaging in Primary Prostate Cancer. [2022]

4. England pubmed.ncbi.nlm.nih.gov

ENZA-p trial protocol: a randomized phase II trial using prostate-specific membrane antigen as a therapeutic target and prognostic indicator in men with metastatic castration-resistant prostate cancer treated with enzalutamide (ANZUP 1901). [2022]

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

177Lu-PSMA and 177Lu-DOTATATE Therapy in a Patient With Metastatic Castration-Resistant Prostate Cancer and Neuroendocrine Differentiation. [2023]