Investigation of GLP1-Receptor Agonists in Men With Prostate Cancer Taking Androgen Deprivation Therapy
NCT ID: NCT06908694
Last Updated: 2025-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
20 participants
INTERVENTIONAL
2025-07-02
2026-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
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.
TREATMENT
NONE
Study Groups
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Semaglutide
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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McMaster University
OTHER
Hamilton Health Sciences Corporation
OTHER
Responsible Party
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Principal Investigators
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Darryl Leong, MBBs,MPH,PhD,FRACP,FESC
Role: PRINCIPAL_INVESTIGATOR
Population Health Research Institute and McMaster University
Jehonathan Pinthus, MD,FRCS(C),PhD
Role: PRINCIPAL_INVESTIGATOR
Juravinski Cancer Centre
Locations
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Juravinski Cancer Centre
Hamilton, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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5100
Identifier Type: -
Identifier Source: org_study_id
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