First-in-human Study of 225Ac-PSMA-Trillium (BAY 3563254) in Participants With Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC)
This research is looking at a new treatment called BAY3563254 for men with advanced prostate cancer. This is a type of prostate cancer that has spread to other parts of the body and is no longer helped by hormone treatments. The new drug works by finding specific cancer cells and delivering a small amount of radiation to them, aiming to stop them from growing. This first study in humans wants to find out if BAY3563254 is safe, what the right dose is, and how well it helps to shrink or stop the cancer. Researchers will carefully check for any side effects and see how the cancer responds to the treatment.
At a glance
What is this study about?
Researchers are working to find better treatments for men with advanced prostate cancer that has spread and is no longer responding to standard hormone therapy. This type of cancer is called metastatic castration-resistant prostate cancer (mCRPC). It means the cancer, which starts in the prostate gland (a small gland below the bladder in men), has spread to other areas of the body.
The new treatment being studied is called BAY3563254. It's designed to specifically target prostate cancer cells. Many prostate cancer cells have a special marker on their surface called PSMA. BAY3563254 works by attaching to these PSMA markers and then delivering a small, targeted dose of radiation directly to the cancer cells. This radiation is intended to damage the cancer cells and stop them from growing and spreading, while trying to limit harm to healthy cells.
This is a very early study, the first time this treatment is being given to people. The main goals are to check how safe BAY3563254 is, to find the best dose that is both safe and potentially effective, and to get an early idea of how well it can help men with this advanced form of prostate cancer. Researchers will be carefully monitoring participants for any side effects and tracking changes in their cancer.
Key takeaways
- This is a study for advanced prostate cancer that has spread and isn't responding to hormone therapy.
- The new drug, BAY3563254, uses targeted radiation to fight cancer cells.
- It's a 'first-in-human' study focusing on safety and finding the right dose.
- Participation involves regular hospital visits, scans, blood tests, and long-term follow-up.
- You would receive the treatment as an injection into a vein, given every 6 or 8 weeks for up to 4 cycles.
- You have the right to leave the study at any time.
Who may be eligible?
To join this study, men must have advanced prostate cancer that has spread and is no longer responding to hormone therapy. You will also need to have tried certain other prostate cancer treatments in the past, including particular hormone-based medications.
Depending on which part of the study you might join, there are different requirements regarding chemotherapy treatments (like taxanes) you may or may not have had. For one specific group, you also need to have received a type of radiation treatment called Lu-PSMA therapy previously, and it must have been well-tolerated.
Your general health needs to be good enough to take part, specifically, doctors will check your blood counts, liver, and kidney function to make sure you are well enough. You must also be at least 18 years old.
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.
- Do I have advanced prostate cancer that has spread?
- Is my prostate cancer no longer responding to hormone therapy?
- Have I tried similar hormone-based prostate cancer drugs before?
- Am I at least 18 years old?
- Is my general health good enough as assessed by my doctor (e.g., blood counts, liver and kidney function)?
- Have I received (or not received) specific chemotherapy drugs (like taxanes), depending on the study group?
What does participation involve?
If you join this study, it will be in two main parts. In the first part, different participants will receive different, gradually increasing amounts of BAY3563254 as an injection into a vein to find the safest and most effective dose. In the second part, all participants will receive the best dose found in the first part. You will get the study treatment once every 6 or 8 weeks, which is called a treatment cycle, for up to 4 cycles, as long as it is helping you.
During the study, you will have regular hospital visits. Doctors and nurses will take blood and urine samples, check your blood pressure and heart rate, and perform heart checks (ECG). They will also use scans like CT, MRI, bone scans, and PET scans to see how your cancer is doing. Sometimes, they might need to take a small sample of your tumour. You'll also be asked about how you're feeling and any side effects you might have. You will also complete questionnaires about your quality of life.
After your treatment cycles finish, you'll be followed up regularly. For the first 18 months, check-ups will be quite frequent, every 6 weeks. After that, you'll have long-term follow-up for up to 60 months (5 years) after your last dose, usually with phone calls or clinic visits every 12 weeks. The total time you could be involved in the study, including screening, treatment, and follow-up, could be around 6 years.
Potential risks and benefits
Locations (35)
- City of Hope - Duarte Cancer CenterVerified postcodeDuarte, United States· Not yet recruiting
- M Health Fairview Masonic Cancer Clinic - Clinics and Surgery CenterVerified postcodeMinneapolis, United States· Not yet recruiting
- XCancer OmahaVerified postcodeOmaha, United States· Not yet recruiting
- The University of Texas MD Anderson Cancer Center - Texas Medical CenterVerified postcodeHouston, United States· Not yet recruiting
- Institut Jules Bordet / Nuclear MedicineVerified postcodeAnderlecht, Belgium· Recruiting
- AZ Groeninge Campus Kennedylaan - UrologyVerified postcodeKortrijk, Belgium· Recruiting
- UZ Leuven - Campus Gasthuisberg - Nuclear MedicineVerified postcodeLeuven, Belgium· Not yet recruiting
- Cross Cancer Institute | Clinical Trials UnitVerified postcodeEdmonton, Canada· Withdrawn
- BC Cancer | VancouverVerified postcodeVancouver, Canada· Recruiting
- Juravinski Cancer Centre | Clinical TrialsVerified postcodeHamilton, Canada· Recruiting
- Princess Margaret Cancer Centre - University Health Network - Department of Medical Oncology and HematologyVerified postcodeToronto, Canada· Recruiting
- Centre Hospitalier de l'Universite de Montreal (CHUM) | OncologyVerified postcodeMontreal, Canada· Recruiting
Common questions
What is mCRPC?
mCRPC stands for metastatic castration-resistant prostate cancer. This is prostate cancer that has spread to other parts of the body and is no longer helped by hormone treatments that lower testosterone.
How does the new treatment, BAY3563254, work?
It's designed to attach to specific markers on prostate cancer cells (called PSMA) and then deliver a small dose of radiation directly to those cells to stop them from growing.
What is a 'first-in-human' study?
This means it's the very first time this new treatment is being given to people. The main goals are to check how safe it is and to find the right amount (dose) to give.
How long will I be involved in the study?
Including screening, treatment, and long-term follow-up, you could be involved for up to 6 years, but treatment itself lasts for up to 4 cycles (around 6-8 months if beneficial).
Can I stop being part of the study at any time?
Yes, your participation is completely voluntary, and you can decide to leave the study at any point without it affecting your medical care.
How to find out more
Bayer Clinical Trials Contact
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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