Menu
Recruiting NCT06908694

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

Phase IV Interventional Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Semaglutide Pen Injector.
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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, 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.

Interventions

  • Drug 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

  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Juravinski Cancer Centre — Hamilton

Identifiers

NCT: NCT06908694 · 5100

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗