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Not yet recruitingPHASE2INTERVENTIONAL

External Beam and Radioligand Radiotherapy for mCRPC

This study is for men with advanced prostate cancer that has spread and is no longer responding to hormone therapy. It's looking into whether adding a precise type of X-ray treatment (EBRT) to an existing 'smart bomb' drug (177Lu-PSMA) can improve outcomes. The smart drug targets prostate cancer cells, but sometimes doesn't deliver enough treatment to all areas. This study hopes that adding EBRT will boost the treatment in specific areas, reducing the risk of bone problems like fractures, without causing more side effects. Researchers want to see if this combined approach leads to better results for patients.

At a glance

Status
Not yet recruiting
Phase
PHASE2
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Enrolment target
120
Start
01 May 2026
Estimated completion
01 May 2028

What is this study about?

This study is called ARREST and it's looking at a new way to treat advanced prostate cancer. This is specifically for men whose cancer has spread to other parts of the body and is no longer responding to standard hormone treatments. Currently, one treatment option is a 'smart bomb' drug called 177Lu-PSMA. This drug has a special tag that helps it find and stick to prostate cancer cells, delivering radiation directly to them and helping to kill them off.

However, sometimes, not all cancer spots get enough of this targeted radiation, which means they might not be fully treated. This study wants to see if adding a very precise type of X-ray therapy, called External Beam Radiotherapy (EBRT), to the 177Lu-PSMA treatment can help. EBRT delivers targeted radiation to specific areas of the body, like cancer spots in bones. The idea is that this extra, focused treatment could top up the radiation dose to areas that might not have received enough from the smart drug alone.

The main goal is to find out if this combined approach can reduce the risk of serious bone-related problems, like broken bones or pressure on the spinal cord, which can be caused by prostate cancer spreading to the bones. The researchers also want to make sure that combining these treatments doesn't cause more side effects or make patients feel worse. It's about finding a personalized way to give the most effective treatment safely.

Key takeaways

  • This study explores a new way to treat advanced prostate cancer.
  • It combines a 'smart' drug (177Lu-PSMA) with focused X-ray therapy (EBRT).
  • The main goal is to reduce bone-related problems from cancer.
  • It's a randomised study, so you might get the standard or new treatment.
  • Your health and well-being will be closely monitored.

Who may be eligible?

This study is looking for men who already have advanced prostate cancer that has spread to other parts of their body and are currently receiving the 177Lu-PSMA 'smart bomb' treatment. To be considered, you should also be generally well enough to go about your daily activities with little difficulty, and you need to have some cancer spots that could potentially be treated with the focused X-ray therapy (EBRT).

You should also be receiving medication to help protect your bones, as this is common for men with advanced prostate cancer. The study is specifically for men, and there are no age restrictions, meaning adults of any age might be able to take part.

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.

  1. I have advanced prostate cancer that has spread.
  2. I am currently receiving 177Lu-PSMA treatment.
  3. I feel well enough for most daily activities.
  4. I am currently taking medication to protect my bones.
  5. My cancer has spots that could be treated with focused X-rays.
Answer every question to see your result.

What does participation involve?

If you join the study, you'll either continue to receive the standard 177Lu-PSMA therapy alone (up to 6 cycles), or you'll receive the 177Lu-PSMA therapy along with additional focused X-ray therapy (EBRT) to specific cancer spots. The EBRT treatment, if you receive it, will be given between your cycles of the 177Lu-PSMA drug and usually takes less than an hour per session.

Throughout the study, you'll have regular check-ups, which include scans like FDG-PET and SPECT-CT, and blood tests to measure your PSA levels (a marker for prostate cancer). The team will be carefully monitoring any side effects and how you're feeling. The main aim is to track your health for one year to see if you experience any bone-related problems, but overall health and well-being will also be followed.

Potential risks and benefits

Taking part in this study could potentially offer a benefit by reducing your risk of developing serious bone-related problems like fractures, which can significantly impact your quality of life. There's also the chance that the combined treatment might be more effective at controlling your cancer. However, as with any medical treatment, there are potential risks and side effects from both the 177Lu-PSMA and the additional X-ray therapy (EBRT). The research team will carefully monitor you for any side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your ongoing medical care.

Locations (1)

  • Centre Hospitalier de l'Université-de-Montréal
    Verified postcode
    Montreal, Canada

Common questions

What is 'advanced prostate cancer'?

Advanced prostate cancer means the cancer has spread from the prostate gland to other parts of the body, and it's no longer responding to standard hormone therapy.

What is 177Lu-PSMA?

177Lu-PSMA is a 'smart bomb' drug that finds and attaches to prostate cancer cells, delivering radiation directly to them to help shrink or kill them.

What is EBRT?

EBRT (External Beam Radiotherapy) is a type of X-ray treatment that uses a machine to send focused radiation beams to specific areas of your body where the cancer is.

What are 'bone-related problems'?

These are issues like broken bones, pressure on the spinal cord, or needing surgery or radiation to relieve bone pain, all caused by prostate cancer spreading to the bones.

Will I definitely get the new combined treatment?

No, participants are randomly assigned to either receive the standard 177Lu-PSMA treatment alone or the combined treatment with additional EBRT. It's like flipping a coin.

How to find out more

Mom Phat

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "External Beam and Radioligand Radiotherapy for mCRPC…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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