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

NCT06908694 | Recruiting Phase 4

• 1 other identifier: 5100
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Androgen Deprivation Therapy; GLP-1 Receptor Agonists

Outcome Measures

Primary Outcomes (11)

• 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

• Number of Adverse Events leading to Drug Discontinuation

  Adverse Events leading to Drug Discontinuation

  6 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

Study Arms (1)

Semaglutide

EXPERIMENTAL

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

Interventions

Semaglutide Pen Injector DRUG

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.

Also known as: Wegovy®

Semaglutide

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• McMaster University: collaborator

Study Sites (1)

Juravinski Cancer Centre

Hamilton, Ontario, L8V1C3, Canada

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Karampatos, BASc, MSc

CONTACT

905-296-5795; sarah.karampatos@phri.ca

Steven Agapay, BSc

CONTACT

905-296-5764; steve.agapay@phri.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label single-arm phase IV trial. Following enrolment, all participants will undergo a baseline visit, a 1-month telephone follow-up visit, 3-month visit, 6-month and 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 Record Dates

• First Submitted: March 26, 2025
• First Posted: April 3, 2025
• Study Start: July 2, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)