Using semaglutide to reduce weight and metabolic effects in men on androgen deprivation therapy for prostate cancer
GLP1-Receptor Agonists in Men With Prostate Cancer: Control of Cardiovascular Risk Factors and Prostate Biomarkers
This study tests whether semaglutide (a GLP-1 receptor agonist) helps men with prostate cancer on androgen deprivation therapy lose weight and improve blood sugar, lipids, and other metabolic measures.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Hamilton Health Sciences Corporation Academic / other |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT06908694 on ClinicalTrials.gov |
What this trial studies
This is an open-label, single-arm Phase IV trial giving semaglutide by weekly subcutaneous injection to men with prostate cancer who are receiving or planned to receive androgen deprivation therapy. Participants follow a dose-escalation schedule up to 2.4 mg weekly, with the dose reduced if adverse effects occur. Safety and tolerability will be monitored and investigators will measure weight, waist circumference, blood pressure, HbA1c, lipids, PSA, creatinine and estimated glomerular filtration rate over 12 months with visits at baseline, 1 month (phone), 3, 6 and 12 months. The trial enrolls men with elevated BMI (≥30 kg/m2 or ≥27 kg/m2 with a cardiometabolic comorbidity) who are not already taking a GLP-1 receptor agonist.
Who should consider this trial
Good fit: Ideal candidates are adult men with a physician diagnosis of prostate cancer who are receiving or will receive androgen deprivation therapy and have elevated BMI (≥30 kg/m2 or ≥27 kg/m2 with hypertension, type 2 diabetes, obstructive sleep apnea, or dyslipidemia) and are not already taking a GLP-1 receptor agonist.
Not a fit: Patients with type 1 diabetes, a history of pancreatitis, a personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2, or those already taking a GLP-1 receptor agonist are unlikely to benefit from or be eligible for this intervention.
Why it matters
Potential benefit: If successful, semaglutide could reduce weight and cardiometabolic risk in men on ADT, improving quality of life and lowering treatment-related complications.
How similar studies have performed: GLP-1 receptor agonists like semaglutide have shown consistent weight loss and metabolic benefits in general populations, but their specific use and safety profile in men on ADT is relatively untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hamilton, Ontario
- Juravinski Cancer Centre — Hamilton, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Darryl Leong, MBBs,MPH,PhD,FRACP,FESC — Population Health Research Institute and McMaster University
- Study coordinator: Sarah Karampatos, BASc, MSc
- Email: sarah.karampatos@phri.ca
- Phone: 905-296-5795
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.