Prostate Cancer
Conditions
Keywords
Androgen Deprivation Therapy, GLP-1 Receptor Agonists
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.
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
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.
Sponsors
McMaster University
Hamilton Health Sciences Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label single-arm phase IV trial. Following enrolment, all participants will undergo a baseline visit, a 1-month telephone follow-up visit, 3-month visit, 6-month and 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.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada
Contacts
Primary ContactSarah Karampatos, BASc, MSc
Backup ContactSteven Agapay, BSc
Outcome results
None listed