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NCT Number: NCT06908694

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Juravinski Cancer Centre

Hamilton, Ontario, L8V1C3, Canada

Location status: Recruiting

Location contact

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

PRINCIPAL_INVESTIGATOR

Jehonathan Pinthus, MD,FRCS(C),PhD

PRINCIPAL_INVESTIGATOR

Nadra Yasmin

CONTACT

[email protected]

Shauna Szendrey

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • ≥30kg/m2 or
  • ≥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

Treatment and study plan

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.

Other names: Wegovy®

Primary outcomes

  1. Number of Serious Adverse Events

    Time frame: 12 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.

  2. Number of Adverse Events leading to Drug Discontinuation

    Time frame: 6 months

    Adverse Events leading to Drug Discontinuation

  3. Measure of Weight

    Time frame: 12 months

    Measure of Weight

  4. Measure of Waist Circumference

    Time frame: 12 months

    Measure of Waist Circumference

  5. Measure of Blood Pressure

    Time frame: 12 months

    Measure of Blood Pressure

  6. Concentration of HbA1c

    Time frame: 12 months

    Concentration of HbA1c

  7. Concentration of Lipids

    Time frame: 12 months

    Total Cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides

  8. Concentration of PSA

    Time frame: 12 months

    Concentration of PSA

  9. Concentration of Creatinine

    Time frame: 12 months

    Concentration of Creatinine

  10. Calculation of estimated glomerular rate

    Time frame: 12 months

    Calculation of estimated glomerular rate

  11. Number of Clinical Outcomes

    Time frame: 12 months

    Death, Hospitalization, New Diabetes, Myocardial Infarction, Stroke, Heart Failure, Peripheral Arterial Disease, Venous Thromboembolism

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Karampatos, BASc, MSc

CONTACT

[email protected]

905-296-5795

Steven Agapay, BSc

CONTACT

[email protected]

905-296-5764

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Collaborators

  • McMaster University

Registry information

Official study title

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

Acronym: GAINPCCONTROL

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 3, 2025
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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