A Phase 2, randomized, open-label, dose-finding study of Debio 4228, an extended-release formulation of gonadotropin-releasing hormone antagonist in participants with advanced prostate cancer
Prostate cancer cells often rely on testosterone, a male hormone, to grow and spread. This Phase 2 study is testing a new, long-acting injection called Debio 4228 in men with advanced prostate cancer. The medicine is designed to release slowly into the body over several weeks to lower testosterone levels. The main goal of the trial is to find the best dose. Doctors want to see how long the medicine stays in the blood and how well it reduces both testosterone and PSA, a protein linked to prostate cancer. Participants will receive the injection and attend regular clinic visits for blood tests, health checks, and monitoring. Researchers will also check for common side effects, such as redness or soreness around the injection site. Taking part could help improve future treatment options for men living with prostate cancer.
At a glance
What is this study about?
Prostate cancer is the most common cancer in men in the UK. When prostate cancer is advanced, it means the cancer has spread beyond the prostate gland or returned after earlier treatment. Standard treatment usually includes hormone therapy. Hormone therapy works by reducing the amount of testosterone in the body. Because testosterone acts like fuel for prostate cancer cells, lowering this hormone can shrink tumors or slow their growth.
Currently, some hormone therapies require frequent injections. Debio 4228 is an experimental, slow-release form of a hormone drug called degarelix. Because it is designed to break down slowly, it releases medicine into the bloodstream over a longer period. Researchers hope this may allow men to maintain low hormone levels with fewer injections over time.
This Phase 2 study focuses on finding the right dose of Debio 4228. Doctors will check how the drug travels through the body, how quickly it reduces testosterone, and whether it keeps testosterone low over 12 to 24 weeks. They will also look at safety, overall health, and changes in PSA levels to see how well the treatment is working.
Key takeaways
- Tests a new, slow-release hormone therapy injection for advanced prostate cancer.
- Aims to lower testosterone levels to slow down cancer growth.
- Open to men aged 18 and older with advanced prostate cancer.
- Involves clinic visits, blood tests, and health checks over 3 to 6 months.
- Participation is completely voluntary and you can withdraw at any time.
Who may be eligible?
This study is open to men aged 18 and older who have been diagnosed with advanced prostate cancer. Because the treatment specifically targets male hormones to treat prostate cancer, only adult men can take part.
To join, you must be well enough to attend regular clinic visits and have routine tests. The study team will review your medical history, previous cancer treatments, and current blood results to make sure it is safe for you to take part.
You may not be eligible if you have certain other severe medical conditions, serious heart problems, or if you are taking medicines that could interfere with the study drug. Your cancer specialist can review the full criteria with you to see if the trial is suitable.
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.
- I am a man aged 18 or older.
- I have been diagnosed with advanced prostate cancer.
- I am able to attend regular hospital visits over 3 to 6 months.
- I am willing to receive injections under the skin and have routine blood tests.
- I can give informed consent to take part in a clinical trial.
What does participation involve?
If you take part, your participation will last between 3 and 6 months (around 12 to 24 weeks), depending on which dose group you are in. You will receive an injection of Debio 4228 under your skin at the clinic.
You will need to visit the hospital regularly for health checks. These visits will include blood tests to check your hormone levels, PSA, and how much medicine remains in your body. Doctors will also check your heart with an electrocardiogram (ECG), measure your blood pressure, and track your weight. After each injection, the team will check the skin around the injection site for redness or swelling, and you will be asked to score any mild pain or discomfort. Once the treatment phase is complete, there will be follow-up checks to monitor your recovery.
Potential risks and benefits
Locations (7)
- —UnverifiedFrance
- —UnverifiedBelgium
- —UnverifiedSpain
- —UnverifiedPoland
- —UnverifiedBulgaria
- —UnverifiedItaly
- —UnverifiedLithuania
Common questions
What is the main goal of this study?
The goal is to find the best dose of Debio 4228 and check how safely and effectively it lowers testosterone in men with advanced prostate cancer.
How is the medicine given?
Debio 4228 is given as a slow-release injection under the skin, allowing the medicine to work over several weeks.
Will I know which dose I am receiving?
Yes. This is an open-label study, which means both you and your doctors will know the exact dose you are receiving.
Do I have to pay to take part in this trial?
No. The trial medicine and all study-related tests are provided free of charge, and travel costs may be reimbursed.
Can I leave the study if I change my mind?
Yes. You can leave the study at any time without giving a reason, and your regular medical care will not be affected.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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