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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.

De un vistazo

Estado
Reclutamiento
Fase
FASE4
Patrocinador
Hamilton Health Sciences Corporation
Objetivo de inscripción
20
Inicio
02 Jul 2025
Estimación de finalización
31 Jul 2026

¿De qué trata este estudio?

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.

Puntos clave

  • 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.

¿Quién puede ser elegible?

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.

¿Podría este estudio ser adecuado para ti?

Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.

  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?
Responde cada pregunta para ver tu resultado.

¿En qué consiste la participación?

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.

Riesgos y beneficios potenciales

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.

Ubicaciones (1)

  • Centro de Cáncer Juravinski
    Código postal verificado
    Hamilton, Canadá· Reclutamiento

Preguntas comunes

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.

¿Cuánto tiempo estaré involucrado en el estudio?

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

Cómo obtener más información

Sarah Karampatos, BASc, MSc

Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.

¿Interesado en participar?

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