The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT Global)
This study, called ProstACT Global, is for men with advanced prostate cancer that has spread (metastatic) and is resistant to hormone treatment (castration-resistant). We want to see if adding a new drug, 177Lu-TLX591, to standard treatments like enzalutamide, abiraterone, or docetaxel, is better than using standard treatments alone. The main goal is to find out if the new drug helps to slow down or stop the cancer from growing for longer. Participants will receive either the new drug plus standard care or standard care alone. We will monitor their cancer and overall health over a long period. This research aims to find more effective ways to treat this type of prostate cancer.
At a glance
What is this study about?
This research study, known as ProstACT Global, is designed for men who have advanced prostate cancer. This means the cancer has spread to other parts of the body (metastatic) and has stopped responding to the usual hormone-blocking treatments (castration-resistant).
The main purpose of this study is to investigate a new treatment called 177Lu-TLX591. We want to see if adding this new drug to treatments you might already be taking, such as enzalutamide, abiraterone, or docetaxel (which are considered standard care), is more effective than continuing with standard care alone. The hope is that 177Lu-TLX591 will help stop or slow down the cancer from growing and spreading for a longer time.
To make sure this new treatment is safe and works, the study is split into three main parts. First, a small group of patients will help us confirm the safety and how the new drug moves through the body. Then, a larger group of patients will be randomly assigned to receive either the new drug plus standard care or standard care by itself. All patients will be carefully followed for at least five years to check on their health and how their cancer is responding. Only men whose cancer cells show a specific marker, called PSMA, will be able to take part in this study, as the new drug targets these cells.
Key takeaways
- Investigating a new drug, 177Lu-TLX591, for advanced prostate cancer.
- Compares the new drug plus standard care to standard care alone.
- Aims to slow cancer growth in men with metastatic, castration-resistant prostate cancer.
- You might receive the new drug or standard care through a random assignment.
- Requires cancer cells to show a specific marker called PSMA.
- Long-term follow-up of at least 5 years to monitor effects.
Who may be eligible?
To be considered for this study, you need to be a man aged 18 or older with prostate cancer that has been confirmed by a doctor. Your health and ability to carry out daily activities should be generally good, meaning you can mostly look after yourself. The cancer must have spread to other parts of your body, and it should no longer be responding well to hormone therapy, meaning your testosterone levels are low but your cancer is still growing.
You must have already received at least 12 weeks of a specific type of hormone treatment (like abiraterone, apalutamide, darolutamide, or enzalutamide), and your cancer must have continued to grow despite this treatment. If you received docetaxel chemotherapy a while ago (at least 6 months ago) for earlier-stage cancer, you might still be eligible.
Crucially, your cancer needs to be showing signs of continued growth when you enter the study. This could be changes in your PSA blood test, or new or growing cancer spots seen on scans. Also, your cancer must show a specific feature called PSMA, which doctors will check from your scans.
- Are you a man, aged 18 or older?
- Do you have prostate cancer that has spread?
- Is your prostate cancer no longer responding well to hormone therapy?
- Have you already received at least 12 weeks of certain hormone treatments (like enzalutamide or abiraterone) and your cancer progressed?
- Do your scans show that your cancer cells have a marker called PSMA?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to join this study, it will be divided into three main stages. Initially, a small group of around 30 patients will take part in a safety and dosing phase (Part 1). This helps us understand if the new drug is safe and how it works in the body.
After this, a larger group of about 490 patients will be randomly assigned to one of two groups (Part 2). Two out of three patients will receive the new drug, 177Lu-TLX591, alongside their usual standard care (enzalutamide, abiraterone, or docetaxel). The remaining one-third of patients will receive only their usual standard care. Which group you are in is decided by chance, like flipping a coin.
Throughout the study, you will have regular visits for check-ups, blood tests, and scans to monitor your cancer and overall health. All patients will be followed for a long time, at least five years from when they first receive the treatment. This long-term follow-up (Part 3) helps us understand the long-term effects of the treatment.
Potential risks and benefits
Locations (31)
- Chao Family Comprehensive Cancer CentreOrange, United States· Active not recruiting
- Biogenix Molecular LLCMiami, United States· Active not recruiting
- United TheranosticsGlen Burnie, United States· Active not recruiting
- XCancer OmahaOmaha, United States· Active not recruiting
- Columbia University Herbert Irving Comphrensive Cancer CenterNew York, United States· Recruiting
- University HospitalCleveland, United States· Active not recruiting
- OHSU Knight Cancer CenterPortland, United States· Active not recruiting
- Intermountain HealthMurray, United States· Active not recruiting
- Intermountain HealthSalt Lake City, United States· Active not recruiting
- Westmead HospitalSydney, Australia· Recruiting
- Nepean HospitalSydney, Australia· Recruiting
- Wollongong HospitalWollongong, Australia· Recruiting
+19 more sites — see the official record for the full list.
Common questions
What is 'castration-resistant prostate cancer'?
This means your prostate cancer is still growing even though your body's testosterone levels are very low, usually due to hormone therapy.
What is 'standard of care' in this study?
Standard of care refers to currently approved and commonly used treatments for advanced prostate cancer, such as enzalutamide, abiraterone, or docetaxel chemotherapy.
Will I definitely get the new drug if I join?
In the main part of the study, there's a 2 in 3 chance you'll receive the new drug plus standard care, and a 1 in 3 chance you'll receive standard care alone. This is decided by chance.
What does 'PSMA-positivity' mean?
PSMA is a protein found on the surface of some prostate cancer cells. The new drug, 177Lu-TLX591, is designed to target these specific cells. Doctors will check for this before you join.
How long will I be in the study?
You'll be followed for at least five years from your first treatment dose, or until other circumstances, such as death or being lost to follow-up, occur.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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