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

Hamilton Health Sciences (HHS)

Status and phase: Enrolling; Phase 4

Conditions: Prostate Cancer

Treatments: Drug: Semaglutide Pen Injector

Study type: Interventional

Funder types: Other

Identifiers

NCT06908694

5100

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Semaglutide

Experimental group

Description:

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:

Drug: Semaglutide Pen Injector