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
Prostate cancer can sometimes spread to other areas of the body and stop responding to standard hormone therapy. When this happens, it is known as metastatic castration-resistant prostate cancer. This phase 3 clinical trial is investigating a targeted treatment called 177Lu-PSMA-617 (also known as Pluvicto). This medicine works by seeking out a specific protein found on prostate cancer cells called PSMA. Once attached, it delivers a small dose of radiation directly to the tumour cells to destroy them while aiming to protect healthy tissue. Researchers are comparing this targeted radioactive treatment against switching to a different hormone-blocking tablet (either abiraterone or enzalutamide) in men who have not yet had chemotherapy. The trial aims to see whether 177Lu-PSMA-617 delays cancer growth for longer, helps reduce bone pain and fractures, and improves overall quality of life.
At a glance
What is this study about?
Prostate cancer often relies on male hormones like testosterone to grow. Standard treatments work by blocking these hormones. Over time, however, cancer cells can adapt and start growing again, even when hormone levels in the body are extremely low. If the cancer spreads to other areas, such as the bones or lymph nodes, doctors need new ways to target and treat it.
Many prostate cancer cells have a unique protein on their outer surface called Prostate-Specific Membrane Antigen (PSMA). Scientists have created a targeted medicine, 177Lu-PSMA-617, which acts like a guided missile. It travels through the bloodstream, locks onto the PSMA protein on cancer cells, and delivers a concentrated dose of radiation directly into the tumour. This approach aims to damage the cancer cells from the inside while causing minimal harm to nearby healthy organs.
This trial is called PSMAfore. It focuses on men whose cancer has spread and continued to grow after their first hormone-blocking treatment, but who have not yet had chemotherapy. Participants are randomly allocated to receive either the targeted radioactive treatment or an alternative hormone tablet. The main goal is to find out if 177Lu-PSMA-617 is more effective at stopping the cancer from spreading further on scans and whether it can safely delay the need for chemotherapy.
Key takeaways
- A phase 3 clinical study comparing a targeted radioactive medicine against standard hormone tablets.
- Aimed at men with advanced prostate cancer that has spread and stopped responding to initial hormone therapy.
- Open to men who have not yet had chemotherapy for advanced prostate cancer.
- Requires a specialised PET scan to confirm that cancer cells have the target PSMA protein.
- Participation is entirely voluntary and you can leave the study at any point.
Who may be eligible?
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.
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.
- I am a man aged 18 or older.
- I have prostate cancer that has spread to other parts of my body (metastatic).
- My cancer is growing despite standard hormone-lowering therapy.
- I have not yet received chemotherapy (such as docetaxel) for advanced prostate cancer.
- I am willing to have specialised scans to check if my tumours have the PSMA protein.
What does participation involve?
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.
Potential risks and benefits
Locations (9)
- —UnverifiedSpain
- —UnverifiedSlovakia
- —UnverifiedCzechia
- —UnverifiedSweden
- —UnverifiedBelgium
- —UnverifiedFrance
- —UnverifiedAustria
- —UnverifiedGermany
- —UnverifiedNetherlands
Common questions
Will the radioactive treatment make me dangerous to others?
The medicine releases a small amount of radiation, but your hospital team will provide simple, clear precautions to follow for a few days after each dose to keep family members, children, and pets safe.
Can I choose which treatment I receive?
No. A computer randomly decides which treatment group you join to ensure the trial results are scientifically fair and unbiased.
What happens if my cancer gets worse on the hormone tablets?
The study design includes a 'crossover' option, meaning eligible patients whose cancer progresses on the hormone tablets may be offered the 177Lu-PSMA-617 treatment.
Do I have to pay to take part in this clinical trial?
No. The trial medication and all extra study-related tests are provided free of charge, and travel expenses to and from the hospital may be reimbursed.
Can I still have chemotherapy later if I need it?
Yes. Taking part in this trial does not prevent you from having standard chemotherapy later on if your cancer begins to grow again.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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