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RecruitingPHASE4INTERVENTIONAL

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

This study, called GAIN PC CONTROL, is designed for men with prostate cancer who are currently receiving hormone therapy (androgen deprivation therapy). We are investigating a specific drug called Semaglutide, which is given by a pen injector once a week. The main goals are to check if Semaglutide is safe and well-tolerated for these men, and to see if it has any effects on their body weight, waist size, blood pressure, blood sugar (HbA1c), cholesterol levels, and kidney function. Participation in this study involves regular visits over 12 months, including initial checks, follow-up appointments, and possibly telephone calls to monitor your progress. The dose of Semaglutide will gradually increase throughout the study.

At a glance

Status
Recruiting
Phase
PHASE4
Sponsor
Hamilton Health Sciences Corporation
Enrolment target
20
Start
02 Jul 2025
Estimated completion
31 Jul 2026

What is this study about?

This study, called GAIN PC CONTROL, is for men who have prostate cancer and are being treated with hormone therapy. Hormone therapy, sometimes called androgen deprivation therapy, is a common treatment for prostate cancer, but it can sometimes lead to side effects like weight gain and changes in blood sugar or blood pressure. This research aims to understand if a drug called Semaglutide could be helpful for these men.

Semaglutide belongs to a group of medicines that are already approved for conditions like type 2 diabetes and obesity in some people. In this study, we want to carefully investigate if it's safe for men with prostate cancer who are on hormone therapy, and if it could potentially help manage some of the health changes that might occur during their prostate cancer treatment. This is an 'open-label' study, which means both you and the study team will know that you are receiving Semaglutide.

By taking part, you would be contributing important information that could help doctors better support other men with prostate cancer in the future. The study will monitor various aspects of your health to get a full picture of how Semaglutide affects you.

Key takeaways

  • This study investigates Semaglutide for men with prostate cancer on hormone therapy.
  • It aims to check safety and effects on weight, blood sugar, and blood pressure.
  • Participation involves weekly injections and regular check-ups over 12 months.
  • Eligibility includes prostate cancer, hormone therapy, and an elevated BMI.
  • This is an 'open-label' study, meaning you will know you are receiving the drug.

Who may be eligible?

To be considered for this study, you need to have a diagnosis of prostate cancer and currently be receiving, or about to start, hormone therapy for it. You also need to have an elevated Body Mass Index (BMI). This means your BMI should be 30 or higher. If your BMI is 27 or higher, you might still be eligible if you also have at least one of these conditions: high blood pressure, type 2 diabetes, sleep apnea (breathing stops during sleep), or high cholesterol.

However, there are certain reasons why you wouldn't be able to join. For example, if you have type 1 diabetes, are already taking a similar type of drug called a GLP-1 RA, or are under 18 years old, you wouldn't be able to participate. Also, if you have a history of inflammation of the pancreas (pancreatitis) or certain types of thyroid cancer in yourself or your family, or a specific genetic condition called Multiple Endocrine Neoplasia type 2, you would not be eligible. The study is only for men.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Do I have prostate cancer and am I on or starting hormone therapy?
  2. Is my Body Mass Index (BMI) 30 or higher?
  3. If my BMI is 27 or higher, do I also have high blood pressure, type 2 diabetes, sleep apnea, or high cholesterol?
  4. Do I have type 1 diabetes?
  5. Do I or my family have a history of certain thyroid cancers or pancreas inflammation?
Answer every question to see your result.

What does participation involve?

If you meet the requirements and decide to take part, you'll first have a 'baseline' visit where initial health checks are done. You'll then start taking Semaglutide, which is given once a week using a pen injector under the skin. The dose will start low and gradually increase over the first few months until it reaches the study's full dose. If you experience any side effects, the study team might lower your dose to one that you can better tolerate.

Throughout the study, you'll have several follow-up appointments. This includes a phone call one month after you start, then in-person visits at 3 months, 6 months, and a final visit at 12 months (the 'Close-out' visit). These visits are for monitoring your health, checking how you're feeling, and seeing how the medication is affecting things like your weight, blood sugar, and blood pressure. The total duration of your participation in the trial would be 12 months.

Potential risks and benefits

Taking part in any medical study has potential benefits and potential risks. A potential benefit of this study is that Semaglutide might help manage your weight, blood pressure, or blood sugar, which could be helpful during your prostate cancer treatment. However, as with any medication, there's a chance you might experience side effects. The study team will closely monitor you for any issues and will adjust your medication if needed to ensure your safety. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

  • Juravinski Cancer Centre
    Verified postcode
    Hamilton, Canada· Recruiting

Common questions

What is hormone therapy for prostate cancer?

Hormone therapy, or androgen deprivation therapy, is a treatment for prostate cancer that lowers the level of male hormones, which can help slow down the cancer's growth.

What is Semaglutide?

Semaglutide is a medicine that helps manage blood sugar and weight in some people. In this study, we're looking at how it affects men with prostate cancer on hormone therapy.

How will I take Semaglutide?

You will take Semaglutide once a week using a pen that injects it under your skin, similar to an insulin pen.

Will I know if I'm getting the active drug?

Yes, in this study (called 'open-label'), both you and the medical team will know that you are receiving Semaglutide.

How long will I be involved in the study?

If you join, your participation in the study will last for 12 months.

How to find out more

Sarah Karampatos, BASc, MSc

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Investigation of GLP1-Receptor Agonists in Men With Prostate…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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