PSMAfore: A phase III, Open-label, Multi-Center, Randomized Study Comparing 177Lu-PSMA-617 vs. a Change of androgen receptor-directed therapy in the Treatment of Taxane Naïve Men with Progressive Metastatic Castrate Resistant Prostate Cancer

This trial is designed for adult men aged 18 and over who have advanced prostate cancer that has spread to other parts of the body (metastatic disease). It is specifically for men whose cancer has stopped responding to their initial hormone treatments, meaning the cancer is continuing to grow despite medical efforts to lower testosterone.

To be eligible, your cancer cells must show evidence of the PSMA protein. This is confirmed using a specialised body scan before you join. Additionally, you must be 'taxane-naive', which means you have not previously received common chemotherapy drugs (such as docetaxel or cabazitaxel) for this stage of prostate cancer.

You may not be eligible if your cancer does not show enough PSMA on the preliminary scan, if your kidneys or liver are not functioning well enough to process the medication safely, or if you have certain other medical conditions that could make taking part unsafe.

If you decide to take part, a computer will randomly assign you to one of two groups. One group receives 177Lu-PSMA-617, which is given as an injection or drip into a vein once every six weeks for up to six doses. The other group takes daily hormone tablets (either abiraterone acetate or enzalutamide). You will have regular hospital visits to check your overall health, have blood tests (including PSA levels), and undergo imaging scans (such as CT, MRI, or bone scans) to monitor how the cancer responds. If you are placed in the hormone tablet group and your cancer worsens, you may have the opportunity to switch over to the 177Lu-PSMA-617 treatment. Your participation will continue for as long as the treatment helps and remains safe for you, followed by long-term health check-ups.