Clinical trial NCT06908694: Investigation of GLP1-Receptor Agonists in Men With Prostate Cancer Taking Androgen Deprivation Therapy
Official title: GLP1-Receptor Agonists in Men With Prostate Cancer: Control of Cardiovascular Risk Factors and Prostate Biomarkers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Prostate Cancer
Keywords: Androgen Deprivation Therapy
GLP-1 Receptor Agonists
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
Collaborators: name: McMaster University
First posted: 2025-04-03
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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 and 6-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.
Primary purpose: TREATMENT

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 and 6-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 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

Primary outcomes:
measure: Number of Serious Adverse Events
timeFrame: 6 months
measure: Number of Adverse Events leading to Drug Discontinuation
timeFrame: 6 months
measure: Measure of Weight
timeFrame: 6 months
measure: Measure of Waist Circumference
timeFrame: 6 months
measure: Measure of Blood Pressure
timeFrame: 6 months
measure: Concentration of HbA1c
timeFrame: 6 months
measure: Concentration of Lipids
timeFrame: 6 months
measure: Concentration of PSA
timeFrame: 6 months
measure: Concentration of Creatinine
timeFrame: 6 months
measure: Calculation of estimated glomerular rate
timeFrame: 6 months
measure: Number of Clinical Outcomes
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
Study officials:
affiliation: Population Health Research Institute and McMaster University
name: Darryl Leong, MBBs,MPH,PhD,FRACP,FESC
role: PRINCIPAL_INVESTIGATOR
affiliation: Juravinski Cancer Centre
name: Jehonathan Pinthus, MD,FRCS(C),PhD
role: PRINCIPAL_INVESTIGATOR
References: