Recruiting

Glucagon-Like Peptide-1 Receptor Agonists

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT06908694

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Semaglutide Pen Injector

Study Details

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

Study ID

NCT06908694

Start date

Jul 2, 2025

Status verified date

Mar, 2025

Completion date

Jul 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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 measure

  • Number of Serious Adverse Events [ Time Frame: 12 months ]
  • Number of Adverse Events leading to Drug Discontinuation [ Time Frame: 6 months ]
  • Measure of Weight [ Time Frame: 12 months ]
  • Measure of Waist Circumference [ Time Frame: 12 months ]
  • Measure of Blood Pressure [ Time Frame: 12 months ]
  • Concentration of HbA1c [ Time Frame: 12 months ]
  • Concentration of Lipids [ Time Frame: 12 months ]
  • Concentration of PSA [ Time Frame: 12 months ]
  • Concentration of Creatinine [ Time Frame: 12 months ]
  • Calculation of estimated glomerular rate [ Time Frame: 12 months ]
  • Number of Clinical Outcomes [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Sarah Karampatos, BASc, MSc

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

Steven Agapay, BSc

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

Locations

Juravinski Cancer Centre

Recruiting

Hamilton, Ontario, Canada, L8V1C3

Contacts

Nadra Yasmin

nadra.yasmin@phri.ca

Shauna Szendrey

szendreys@hhsc.ca

Principal Investigator:

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

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

Jul 29, 2025

Last verified

Mar, 2025

Keywords

  • Androgen Deprivation Therapy
  • GLP-1 Receptor Agonists

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2025-07-29.