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

Phase 4

Not yet recruiting

• Conditions: Prostate Cancer
• Interventions: Drug: Semaglutide Pen Injector

• Registration Number: NCT06908694
• Lead Sponsor: Hamilton Health Sciences Corporation

Brief Summary

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.

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 and 6-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 Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-26
• Study Start: 2025-04-01
• Study First Submitted QC: 2025-04-02
• Last Update Submitted: 2025-04-02
• Study First Posted: 2025-04-03
• Last Update Posted: 2025-04-03
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Semaglutide	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.

Primary Outcome Measures

Name	Time	Method
Measure of Blood Pressure	6 months	Measure of Blood Pressure
Concentration of PSA	6 months	Concentration of PSA
Calculation of estimated glomerular rate	6 months	Calculation of estimated glomerular rate
Number of Clinical Outcomes	6 months	Death, Hospitalization, New Diabetes, Myocardial Infarction, Stroke, Heart Failure, Peripheral Arterial Disease, Venous Thromboembolism
Number of Serious Adverse Events	6 months	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.
Number of Adverse Events leading to Drug Discontinuation	6 months	Adverse Events leading to Drug Discontinuation
Concentration of Lipids	6 months	Total Cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides
Concentration of Creatinine	6 months	Concentration of Creatinine
Measure of Weight	6 months	Measure of Weight
Concentration of HbA1c	6 months	Concentration of HbA1c
Measure of Waist Circumference	6 months	Measure of Waist Circumference

Trial Locations

Locations (1)

Juravinski Cancer Centre; 🇨🇦 Hamilton, Ontario, Canada