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

Last updated: July 25, 2025
Sponsor: Hamilton Health Sciences Corporation
Overall Status: Active - Recruiting

Phase

4

Condition

Prostate Cancer, Early, Recurrent

Prostate Cancer

Urologic Cancer

Treatment

Semaglutide Pen Injector

Clinical Study ID

NCT06908694
5100
  • Ages > 18
  • Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a physician diagnosis of PC

  • Must be receiving or planned to receive ADT (gonadotropin releasing hormone agonistor 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

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

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Semaglutide Pen Injector
Phase: 4
Study Start date:
July 02, 2025
Estimated Completion Date:
July 31, 2026

Study 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.

Connect with a study center

  • Juravinski Cancer Centre

    Hamilton, Ontario L8V1C3
    Canada

    Active - Recruiting

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