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.
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
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Number of Serious Adverse Events — 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.
Number of Adverse Events leading to Drug Discontinuation — 6 months Adverse Events leading to Drug Discontinuation
Measure of Weight — 12 months Measure of Weight
Measure of Waist Circumference — 12 months Measure of Waist Circumference
Measure of Blood Pressure — 12 months Measure of Blood Pressure
Concentration of HbA1c — 12 months Concentration of HbA1c
Concentration of Lipids — 12 months Total Cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides
Concentration of PSA — 12 months Concentration of PSA
Concentration of Creatinine — 12 months Concentration of Creatinine
Calculation of estimated glomerular rate — 12 months Calculation of estimated glomerular rate
Number of Clinical Outcomes — 12 months Death, Hospitalization, New Diabetes, Myocardial Infarction, Stroke, Heart Failure, Peripheral Arterial Disease, Venous Thromboembolism
Trial sites (1)
Facility
City
Region
Status
Juravinski Cancer Centre
Hamilton
Ontario
More Hamilton Health Sciences Corporation trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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