A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer
This study is looking for men whose prostate cancer has spread to other parts of the body (metastatic) and is no longer responding to standard hormone treatment (castration-resistant). These men would have tried a hormone-blocking treatment before, but not a specific type of chemotherapy called 'taxane-based' chemotherapy for this advanced stage of cancer. The study will compare a new investigational medicine called BNT324 against a common chemotherapy treatment, docetaxel, which is given with prednisone or prednisolone. Researchers want to find out if BNT324 is safer and more effective at stopping the cancer from growing for longer and helping men live longer overall.
At a glance
What is this study about?
This study is a clinical trial, which means it's a careful research study involving volunteers to test a new medicine. The drug being tested is called BNT324. It's being compared to a standard chemotherapy treatment called docetaxel, which is currently used for a specific type of advanced prostate cancer. The aim is to see if BNT324 is a better option for patients than what is currently available.
This trial is for men who have prostate cancer that has spread to other parts of their body (metastatic) and is no longer responding to hormone treatments (castration-resistant). These men would have already tried certain types of hormone-blocking treatments. The study wants to find out two main things: first, if BNT324 can help patients live longer without their cancer getting worse, and second, if it can help them live longer overall.
It’s important to remember that BNT324 is an investigational drug, meaning it’s not yet approved for general use. Clinical trials like this are how new treatments are carefully tested to make sure they are safe and effective before they can be made available to everyone who might need them.
Key takeaways
- This study tests a new drug (BNT324) against standard chemotherapy for advanced prostate cancer.
- It's for men whose prostate cancer has spread and no longer responds to hormone treatments.
- The goal is to see if BNT324 helps men live longer without cancer worsening, and longer overall.
- Participants will be assigned to one of two treatment groups by chance.
- Taking part involves regular hospital visits, treatments, and check-ups over several years.
- You can withdraw from the study at any time without affecting your regular medical care.
Who may be eligible?
This study is looking for adult men (aged 18 or older) with prostate cancer that has spread and is no longer responding to hormone therapy. You would have already had hormone treatments that block male hormones, but your cancer has started to progress again. You must also not have had a specific type of chemotherapy (called 'taxane-based' chemotherapy) for this advanced stage of prostate cancer.
To join, your prostate cancer needs to be showing signs of progression, which can be seen in blood tests (PSA levels) or on scans. You will also need to be generally well enough to take part in a study like this, as assessed by a doctor.
However, you won't be able to join if you've already had a treatment that targets B7-H3 (which is what BNT324 does), or if you have certain heart problems or a specific type of lung disease (called interstitial lung disease or pneumonitis). There might be other reasons why you can't join, which the study team will discuss with you.
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.
- Are you an adult man (18 or older)?
- Has your prostate cancer spread to other parts of your body?
- Is your cancer no longer responding to hormone treatments?
- Have you had hormone-blocking treatments for your prostate cancer before?
- Have you NOT had 'taxane-based' chemotherapy for your current advanced prostate cancer?
- Are you generally well enough for a study like this?
What does participation involve?
If you join this study, you will first have a screening period of up to 28 days to make sure you are suitable. Then, you'll be put into one of two treatment groups by chance, like flipping a coin. You'll either receive the new medicine BNT324, or the standard chemotherapy docetaxel (plus prednisone/prednisolone).
Both treatments are given in cycles, usually lasting 21 days each. You'll continue treatment for as long as it's helping and you're not having difficult side effects, or until the study ends. During this time, you'll have regular hospital visits for your treatment, blood tests, and scans to check how you're doing and how the treatment is working. An independent safety committee will regularly check on how all participants are doing.
After your treatment finishes, there's a safety follow-up period for 30 days, and then a longer follow-up period to check on your health and survival. The total time you could be involved in the study, including follow-up, is expected to be up to about 58 months (around 4 years and 10 months).
Potential risks and benefits
Locations (30)
- Rocky Mountain Cancer CentersVerified postcodeAurora, United States· Recruiting
- Florida Cancer Specialists- Fort MyersVerified postcodeFort Myers, United States· Recruiting
- Florida Cancer Specialists- St. PetersburgVerified postcodeSt. Petersburg, United States· Recruiting
- Florida Cancer Specialists- West Palm BeachVerified postcodeWest Palm Beach, United States· Recruiting
- Illinois Cancer SpecialistsVerified postcodeNiles, United States· Recruiting
- Illinois CancerCare PCVerified postcodePeoria, United States· Recruiting
- Maryland Oncology HematologyVerified postcodeRockville, United States· Recruiting
- White Plains HospitalVerified postcodeWhite Plains, United States· Recruiting
- Oncology/Hematology Care, Inc.Verified postcodeCincinnati, United States· Recruiting
- SCRI Oncology PartnersVerified postcodeNashville, United States· Recruiting
- Texas Oncology South AustinVerified postcodeAustin, United States· Recruiting
- Texas Oncology Gulf CoastVerified postcodeHouston, United States· Recruiting
Common questions
What does 'metastatic castration-resistant prostate cancer' mean?
It means your prostate cancer has spread to other parts of your body (metastatic) and is no longer responding to treatments that lower male hormone levels (castration-resistant).
What is BNT324?
BNT324 is a new, experimental medicine being tested in this study. It is not yet approved for general use.
Why is this study comparing BNT324 to docetaxel?
Docetaxel is a standard chemotherapy for this type of prostate cancer. The study wants to see if BNT324 is a safer or more effective option than the current standard.
Will I know which treatment I'm getting?
No, you will be assigned to one of two groups by chance (like drawing lots), and you won't know which treatment you're receiving. This helps make the study fair and accurate.
How long will I be in the study?
The treatment phase continues as long as it's helping, but the total time you're involved, including follow-up, could be up to about 4 years and 10 months.
How to find out more
BioNTech clinical trials patient information
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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