Clinical trial

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

Recruiting now · Phase 4 · 1 countries · Registry ID NCT06908694

Recruiting nowPhase 4Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexMale

Healthy volunteersNot accepted

ConditionProstate Cancer

Full registry 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 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

Treatments and study arms

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.

Primary outcomes

Number of Serious Adverse Events12 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 Discontinuation6 months

Adverse Events leading to Drug Discontinuation

Measure of Weight12 months

Measure of Weight

Measure of Waist Circumference12 months

Measure of Waist Circumference

Measure of Blood Pressure12 months

Measure of Blood Pressure

Concentration of HbA1c12 months

Concentration of HbA1c

Concentration of Lipids12 months

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

Concentration of PSA12 months

Concentration of PSA

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Juravinski Cancer Centre🇨🇦 Hamilton, Ontario, Canada

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Nadra YasminContact

Shauna SzendreyContact

Darryl Leong, MBBs,MPH,PhD,FRACP,FESCPrincipal Investigator