Skip to content

Trial · Interventional

Active, not recruitingPhase 4Registry data

Investigation of GLP1-Receptor Agonists in Men With Prostate Cancer Taking Androgen Deprivation Therapy

Short name GAINPCCONTROL

Overview

Status
Active, not recruiting
Phase
Phase 4
Enrollment
20 participants (estimated)
Sponsor
Hamilton Health Sciences Corporation · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Canada

Start
2 Jul 2025
Primary completion
31 Oct 2027 (estimated)
Completion
31 Oct 2027 (estimated)
First posted
3 Apr 2025
Last update posted
14 Sept 2026
Conditions
Prostate Cancer

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2025202620272028
  1. Ph 4

    GAINPCCONTROL

    NCT06908694

    2 Jul 2025 to est. 31 Oct 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Semaglutide Pen InjectorDrug

Arms1

  • Experimental

    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.

Primary outcomes11

Outcomes the sponsor listed as primary.

  1. Number of Serious Adverse Events

    Time frame · 12 months

    Registry description

    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.

  2. Number of Adverse Events leading to Drug Discontinuation

    Time frame · 6 months

    Registry description

    Adverse Events leading to Drug Discontinuation

  3. Measure of Weight

    Time frame · 12 months

    Registry description

    Measure of Weight

  4. Measure of Waist Circumference

    Time frame · 12 months

    Registry description

    Measure of Waist Circumference

  5. Measure of Blood Pressure

    Time frame · 12 months

    Registry description

    Measure of Blood Pressure

  6. Concentration of HbA1c

    Time frame · 12 months

    Registry description

    Concentration of HbA1c

  7. Concentration of Lipids

    Time frame · 12 months

    Registry description

    Total Cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides

  8. Concentration of PSA

    Time frame · 12 months

    Registry description

    Concentration of PSA

  9. Concentration of Creatinine

    Time frame · 12 months

    Registry description

    Concentration of Creatinine

  10. Calculation of estimated glomerular rate

    Time frame · 12 months

    Registry description

    Calculation of estimated glomerular rate

  11. Number of Clinical Outcomes

    Time frame · 12 months

    Registry description

    Death, Hospitalization, New Diabetes, Myocardial Infarction, Stroke, Heart Failure, Peripheral Arterial Disease, Venous Thromboembolism

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

PepBank is a research reference. Talk to a doctor before you use any peptide.