Investigation of GLP1-Receptor Agonists in Men With Prostate Cancer Taking Androgen Deprivation Therapy (GAINPCCONTROL)

GLP1-Receptor Agonists in Men With Prostate Cancer: Control of Cardiovascular Risk Factors and Prostate Biomarkers

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Semaglutide Pen Injector

Detailed Description

GAIN PC CONTROL is an open-label single-arm phase IV trial that will evaluate 1) the safety and tolerability of Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs) in men with prostate cancer (PC) treated with androgen deprivation therapy (ADT); 2) the effects of GLP-1 RAs on weight, waist circumference, blood pressure, HbA1c, lipids, PSA and Creatinine, estimated glomerular filtration rate in men with PC treated with ADT.

Patients who meet eligibility criteria and who provide informed consent will be enrolled to receive semaglutide.

Following enrollment, all participants will undergo a baseline visit, a 1-month telephone follow-up visit, 3-month visit, 6-month and a 12-month (Close-out) visit.

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Steven Agapay, BSc; Phone Number: 905-296-5764; Email: steve.agapay@phri.ca
• Study Contact Backup: Name: Sarah Karampatos, BASc, MSc; Phone Number: 905-296-5795; Email: sarah.karampatos@phri.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8V1C3
      • Recruiting
      • Juravinski Cancer Centre
      • Contact: Shauna Szendrey; Email: szendreys@hhsc.ca
      • Contact: Nadra Yasmin; Email: nadra.yasmin@phri.ca
      • Principal Investigator: Darryl Leong, MBBs,MPH,PhD,FRACP,FESC
      • Principal Investigator: Jehonathan Pinthus, MD,FRCS(C),PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Have a physician diagnosis of PC
• Must be receiving or planned to receive ADT (gonadotropin releasing hormone agonist or antagonist ± androgen receptor pathway inhibitor)

• Elevated BMI

  1. ≥30kg/m2 or
  2. ≥27kg/m2 in the presence of at least one of hypertension, type 2 diabetes, obstructive sleep apnea or dyslipidemia

Exclusion Criteria:

• Type 1 diabetes
• Taking a GLP-1 RA
• <18 years of age
• History of pancreatitis
• Personal or family history of medullary cancer of the thyroid
• Multiple endocrine neoplasia type 2

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Semaglutide; 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.	Drug: Semaglutide Pen Injector; 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.; Other Names: Wegovy®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adverse Events leading to Drug Discontinuation	Adverse Events leading to Drug Discontinuation	6 months
Number of Serious Adverse Events	An event that leads to death; is life-threatening; results in hospitalization or its prolongation; disability or permanent damage; congenital anomaly or birth defect; or other medical event that is considered serious.	12 months
Measure of Weight	Measure of Weight	12 months
Measure of Waist Circumference	Measure of Waist Circumference	12 months
Measure of Blood Pressure	Measure of Blood Pressure	12 months
Concentration of HbA1c	Concentration of HbA1c	12 months
Concentration of Lipids	Total Cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides	12 months
Concentration of PSA	Concentration of PSA	12 months
Concentration of Creatinine	Concentration of Creatinine	12 months
Calculation of estimated glomerular rate	Calculation of estimated glomerular rate	12 months
Number of Clinical Outcomes	Death, Hospitalization, New Diabetes, Myocardial Infarction, Stroke, Heart Failure, Peripheral Arterial Disease, Venous Thromboembolism	12 months

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation
• Collaborators: McMaster University
• Investigators: Principal Investigator: Darryl Leong, MBBs,MPH,PhD,FRACP,FESC, Population Health Research Institute and McMaster University; Principal Investigator: Jehonathan Pinthus, MD,FRCS(C),PhD, Juravinski Cancer Centre

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 3, 2025

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Androgen Deprivation Therapy; GLP-1 Receptor Agonists
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Glucagon-Like Peptide-1 Receptor Agonists; Physiological Effects of Drugs; Hypoglycemic Agents; Semaglutide
• Other Study ID Numbers: 5100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No