Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Lutetium-177-PSMA in Oligo-metastatic Hormone Sensitive Prostate Cancer.

This research is investigating a new treatment called Lutetium-177-PSMA for men who have prostate cancer that's still in its early stages of spreading and responds to hormone therapy. The study wants to find out if this new treatment can prevent the cancer from growing or spreading for longer. Researchers will compare how patients receiving this new treatment fare compared to those receiving standard care over 6 months. They will also look at whether the treatment improves quality of life and what side effects might occur. The main goal is to understand if Lutetium-177-PSMA could be a good option for slowing down prostate cancer in this group of patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Stichting Radboud University Medical Center

Enrolment target

Start

22 Jul 2024

prostate cancer

What is this study about?

This study, called "Lutetium-177-PSMA in Oligo-metastatic Hormone Sensitive Prostate Cancer," is looking into a new way to treat prostate cancer. Prostate cancer is a condition where cells in the prostate gland grow out of control. Sometimes, these cells can spread to other parts of the body, creating new small tumours. When this happens in only a few places, it's called "oligo-metastatic."

The new treatment being studied uses a medicine called Lutetium-177-PSMA. This medicine is designed to target specific proteins on the surface of prostate cancer cells, helping to deliver radiation directly to them while hopefully sparing healthy cells. The study is particularly interested in men whose prostate cancer is still sensitive to hormone therapy, which is a common initial treatment.

The main aim of this research is to see if Lutetium-177-PSMA can slow down or stop the cancer from growing or spreading for a longer time compared to current treatments. The study will also carefully monitor any side effects and see if the treatment helps improve patients' overall quality of life. This is a "Phase II" study, which means it's one of the earlier steps in testing new medicines in people, focusing on safety and how well it works.

Key takeaways

This study explores a new treatment for prostate cancer.
It's for men with early spreading and hormone-sensitive prostate cancer.
The new treatment is called Lutetium-177-PSMA.
The study aims to see if the new treatment can slow cancer growth.
It also checks for side effects and how it affects quality of life.
Participation involves regular check-ups and potentially specialised scans.

Who may be eligible?

To be considered for this study, you would need to be an adult man, 18 years old or older, with prostate cancer.

The study is specifically for men whose prostate cancer has started to spread, but only to a limited number of spots (what doctors call 'oligo-metastatic'). Your cancer also needs to be 'hormone sensitive,' meaning it still responds to standard hormone-blocking treatments.

There will be other specific medical checks and tests that the study doctors will need to carry out to make sure the treatment is safe and appropriate for you. They will explain all of these carefully to you.

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.

Are you an adult male (aged 18 or over)?
Do you have prostate cancer?
Has your prostate cancer spread, but only to a few small areas?
Does your prostate cancer still respond to hormone therapy?
Are you willing to have regular hospital visits and check-ups?
Are you able to understand and agree to the study requirements?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be joining one of two groups. One group would receive the new Lutetium-177-PSMA treatment, and the other would receive standard care. You might also have scans (like special PET/CT and MRI scans) before and after the treatment to see how your cancer is responding. Your doctors will regularly check your blood for things like PSA levels (a marker for prostate cancer) and monitor for any side effects. You'll also be asked about your quality of life. The study will follow you for at least 6 months to see how well the treatment works and how you are feeling generally.

Potential risks and benefits

Taking part in a study like this might offer the chance to receive a new treatment that isn't widely available yet, which could potentially help slow down your cancer. It also helps doctors learn more about prostate cancer and its treatments, which can benefit future patients. However, like all medicines, the new treatment might have side effects, and some could be serious. You will be closely monitored for these. It’s important to remember that you can decide to leave the study at any time, for any reason, without it affecting your usual care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Cyprus
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Unverified
Netherlands

Common questions

What is 'hormone sensitive' prostate cancer?

This means your prostate cancer still responds to treatments that lower male hormones, like testosterone, which can fuel cancer growth.

What does 'oligo-metastatic' mean?

It means your cancer has spread, but only to a small number of spots in other parts of your body, rather than widely.

What is Lutetium-177-PSMA?

It's a new type of treatment that uses a mild radioactive substance to target and kill prostate cancer cells while trying to protect healthy cells.

Will I know if I'm getting the new treatment or standard care?

In some studies, this is decided randomly, and you might not know which treatment you are getting. The study team will explain how this works.

What is the goal of this study?

The main goal is to see if Lutetium-177-PSMA can slow down the growth and spread of prostate cancer for a longer period in certain patients.