Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A randomised, multi-centre, intra-patient imaging and dosimetry crossover study of lutetium (177Lu) rhPSMA-10.1 and lutetium (177Lu) vipivotide tetraxetan (Pluvicto®) in patients with non-curative metastatic prostate cancer

This study is looking at two different treatments, Lutetium-177 rhPSMA-10.1 and Pluvicto, for men who have prostate cancer that has spread to other parts of their body and isn't responding to hormone therapy. We call this 'metastatic castration-resistant prostate cancer' that is PSMA-positive. The main goal is to compare how much radiation each treatment delivers to the cancer cells versus important organs like the kidneys. This helps us understand which treatment might be more effective at targeting the cancer while causing fewer side effects. We're also checking how long the treatments stay in the tumours and other organs, and looking out for any side effects. This is an early-stage study, meaning we're learning about how these treatments work in the body.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Blue Earth Therapeutics Limited

Enrolment target

Start

03 Mar 2025

PSMA-positive non-curative metastatic castration-resistant prostate cancer

What is this study about?

Imagine your body has tiny targets on prostate cancer cells called PSMA. This study is testing two different treatments that act like guided missiles, carrying a small amount of radiation directly to these PSMA targets. The treatments are called Lutetium-177 rhPSMA-10.1 and Lutetium-177 vipivotide tetraxetan (also known as Pluvicto). Both are used for prostate cancer that has spread and is no longer controlled by standard hormone treatments.

The main aim of this study is to carefully look at how much radiation reaches the cancer cells compared to healthy organs, especially the kidneys. If a treatment can deliver more radiation to the cancer and less to healthy tissues, it might be more effective with fewer side effects. Researchers will also be checking how long each treatment stays in the cancer cells and other body parts, and looking for any unwanted side effects that might happen.

By comparing these two treatments, doctors hope to learn more about how they work in the body. This information is crucial for developing better and safer ways to treat advanced prostate cancer in the future. It’s important to remember this is an early stage study, focused on understanding how the treatments behave.

Key takeaways

Compares two radiation treatments for advanced prostate cancer.
Aims to find out which treatment targets cancer better while sparing healthy organs.
Looks at how long treatments stay in tumours and other body parts.
Includes special scans to measure radiation levels.
For men with prostate cancer that has spread and isn't responding to hormone therapy.
Early stage study to understand how treatments work.

Who may be eligible?

To join this study, you must be a man aged 18 or older.

You would be considered if you have prostate cancer that has spread to other parts of your body. This cancer must also be ‘PSMA-positive,’ which means it has specific targets that these treatments can aim for. Your cancer also needs to be advanced to the point where it’s no longer responding to standard hormone treatments, and doctors believe it cannot be cured with current straightforward treatments.

There will be other detailed criteria that the study team will discuss with you to ensure it's safe and appropriate for you to participate.

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 a man aged 18 or older?
Do you have prostate cancer that has spread to other parts of your body?
Has your doctor told you your cancer is 'PSMA-positive'?
Is your prostate cancer no longer responding to hormone treatment, and is it considered advanced?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll receive doses of both Lutetium-177 rhPSMA-10.1 and Pluvicto at different times during the study. This is called a 'crossover' study, meaning you'll get both treatments, but not at the same time. After each treatment, you will have special scans to see where the radiation goes in your body and how long it stays there. This involves imaging tests that help doctors measure the radiation levels in your tumours and in your healthy organs like the kidneys, salivary glands, and bone marrow. You will also have regular check-ups to monitor your health and any side effects. The total duration of your participation in the study, including all treatments and follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit of receiving and being closely monitored on promising new treatments for advanced prostate cancer. However, there's no guarantee that the treatments will work for you. As with any medical treatment, there are potential risks, including side effects from the radiation or the treatments themselves. The study team will explain all known side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (4)

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

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Unverified
Spain
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Unverified
Germany
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Unverified
France
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Unverified
Netherlands

Common questions

What does 'PSMA-positive' mean?

It means your prostate cancer cells have specific proteins called PSMA on their surface, which the study treatments are designed to target.

What is 'metastatic castration-resistant prostate cancer'?

This is prostate cancer that has spread beyond the prostate gland to other parts of the body, and it's no longer responding to hormone therapy.

Why are two treatments being compared?

Doctors want to see which of the two treatments is better at delivering radiation to the cancer and less to healthy organs, hoping for better results and fewer side effects.

What are 'absorbed dose ratios'?

This refers to how much radiation dose is absorbed by the cancer cells compared to healthy organs, helping doctors understand treatment effectiveness and safety.

Will I know which treatment I'm getting?

Yes, in this type of study, you'll receive both treatments at different times, so you will know which one you are receiving at any given point.