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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18+
SponsorHamilton Health Sciences Corporation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Type 1 diabetes

Taking a GLP-1 RA

<18 years of age

History of pancreatitis

Trial design

Design model

Single group

Treatments tested in this trial

  • Semaglutide Pen Injector

    Drug

    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 groups

20 Participants
are divided into 1 treatment group
Group A: SemaglutideExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months
2

Number of Adverse Events leading to Drug Discontinuation

Adverse Events leading to Drug Discontinuation

Time frame
6 months
3

Measure of Weight

Measure of Weight

Time frame
12 months
4

Measure of Waist Circumference

Measure of Waist Circumference

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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