Summary
This study is looking at whether a new type of targeted radioactive treatment called [225Ac]Ac-PSMA-617 works better than standard treatments for advanced prostate cancer.
The main goal is to see if the new treatment can slow down the growth or spread of cancer for longer.
[225Ac]Ac-PSMA-617 (also known as AAA817) is a targeted radioligand therapy. It is designed to attach itself to PSMA, a protein found on prostate cancer cells, and deliver radiation directly to those cells.
It may be given with hormone therapy, whichworks by lowering or blocking the hormones that help prostate cancer grow.
Who is this study for?
You may be able to take part if:
- you have prostate cancer that has spread (metastatic)
- your cancer no longer responds to hormone therapy (castration-resistant)
- your cancer shows PSMA
- you have already had one type of hormone therapy (ARPI)
You may not be able to take part if you have had:
- chemotherapy for advanced prostate cancer, or
- previous PSMA-targeted radioactive treatment
What does taking part involve?
First, there will be a screening period where participants will have tests to check if the study is suitable for them. This includes a PET/CT scan to confirm their cancer is PSMA-positive.
Participants will be randomly assigned (by chance) to one of two treatment groups.
- Investigational group:
- Up to 6 doses of [225Ac]Ac-PSMA-617
- Given through a drip into the vein (IV)
- May also take hormone therapy tablets (enzalutamide or abiraterone)
- Standard treatment group - Doctor will choose one of the following treatments:
- Hormone therapy tablets (enzalutamide or abiraterone)
- Chemotherapy (docetaxel or cabazitaxel)
- Another PSMA-targeted treatment ([177Lu]Lu-PSMA-617)
During the study, participants will have regular check-ups to monitor their health and any side effects. They can receive supportive care (such as treatments to manage symptoms), including ongoing hormone therapy. Participants cannot switch between treatment groups once assigned.