Prostate CancerPhase 4GAINPCCONTROLNCT06908694
Investigation of GLP1-Receptor Agonists in Men With Prostate Cancer Taking Androgen Deprivation Therapy
A Phase 4 study testing Semaglutide Pen Injector in people with Prostate Cancer, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Semaglutide Pen Injector
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 2 Jul 2025to 31 Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- ≥30kg/m2 or
- ≥27kg/m2 in the presence of at least one of hypertension, type 2 diabetes, obstructive sleep apnea or dyslipidemia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GLP1-Receptor Agonists in Men With Prostate Cancer: Control of Cardiovascular Risk Factors and Prostate Biomarkers
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Semaglutide Pen Injector
- Keywords
- Androgen Deprivation Therapy, GLP-1 Receptor Agonists
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide Pen InjectorDrug
Also called Wegovy®
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.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Experimental | 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. Receives: Drug: Semaglutide Pen Injector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Serious Adverse Events
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.
Measured: 12 months
Number of Adverse Events leading to Drug Discontinuation
Adverse Events leading to Drug Discontinuation
Measured: 6 months
Measure of Weight
Measure of Weight
Measured: 12 months
Measure of Waist Circumference
Measure of Waist Circumference
Measured: 12 months
Measure of Blood Pressure
Measure of Blood Pressure
Measured: 12 months
Concentration of HbA1c
Concentration of HbA1c
Measured: 12 months
Concentration of Lipids
Total Cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides
Measured: 12 months
Concentration of PSA
Concentration of PSA
Measured: 12 months
Concentration of Creatinine
Concentration of Creatinine
Measured: 12 months
Calculation of estimated glomerular rate
Calculation of estimated glomerular rate
Measured: 12 months
Number of Clinical Outcomes
Death, Hospitalization, New Diabetes, Myocardial Infarction, Stroke, Heart Failure, Peripheral Arterial Disease, Venous Thromboembolism
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start2 Jul 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Sponsor
- Investigators
- Darryl Leong, MBBs,MPH,PhD,FRACP,FESC, Principal investigator, Population Health Research Institute and McMaster UniversityJehonathan Pinthus, MD,FRCS(C),PhD, Principal investigator, Juravinski Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908694
- Sponsor's protocol ID
- 5100
- Acronym
- GAINPCCONTROL
- Status last verified
- Sep 2026
- First submitted
- 26 Mar 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GLP1-Receptor Agonists in Men With Prostate Cancer: Control of Cardiovascular Risk Factors and Prostate Biomarkers
- ClinicalTrials.gov ID
- NCT06908694
- Acronym / sponsor ID
- GAINPCCONTROL / 5100
- Conditions
- Prostate Cancer
- Keywords
- Androgen Deprivation Therapy, GLP-1 Receptor Agonists
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Experimental | Drug: Semaglutide Pen InjectorThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide Pen InjectorAlso: Wegovy®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. | Drug | Semaglutide |
Primary outcome
Number of Serious Adverse Events
Time frame: 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
Time frame: 6 months
Adverse Events leading to Drug Discontinuation
Measure of Weight
Time frame: 12 months
Measure of Weight
Measure of Waist Circumference
Time frame: 12 months
Measure of Waist Circumference
Measure of Blood Pressure
Time frame: 12 months
Measure of Blood Pressure
Concentration of HbA1c
Time frame: 12 months
Concentration of HbA1c
Concentration of Lipids
Time frame: 12 months
Total Cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides
Concentration of PSA
Time frame: 12 months
Concentration of PSA
Concentration of Creatinine
Time frame: 12 months
Concentration of Creatinine
Calculation of estimated glomerular rate
Time frame: 12 months
Calculation of estimated glomerular rate
Number of Clinical Outcomes
Time frame: 12 months
Death, Hospitalization, New Diabetes, Myocardial Infarction, Stroke, Heart Failure, Peripheral Arterial Disease, Venous Thromboembolism
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darryl Leong, MBBs,MPH,PhD,FRACP,FESC principal investigator
Population Health Research Institute and McMaster University
Jehonathan Pinthus, MD,FRCS(C),PhD principal investigator
Juravinski Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide Pen Injector in people with Prostate Cancer, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Serious Adverse Events (time frame: 12 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.