RecruitingPHASE1, PHASE2INTERVENTIONAL

ACTinium in Castrate-RESistant Prostate Cancer After LUTEtium

This research is looking into a new treatment, Actinium (225Ac) rhPSMA-10.1, for men whose prostate cancer has spread and is no longer responding to standard treatments. This includes men who have already received a similar treatment called Lutetium-PSMA. The new drug is a radioactive injection designed to target and destroy prostate cancer cells. This study is in two parts: the first part will check how safe different doses are, while the second part will test how well the chosen dose works. Participants will receive the injection up to six times, every six weeks, and will have regular check-ups to monitor their health and the treatment's effects. The main goal is to find better ways to treat this type of advanced prostate cancer.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

University College, London

Enrolment target

Start

13 Apr 2026

Estimated completion

30 Dec 2031

Metastatic Castration-resistant Prostate Cancer Metastatic Prostate Cancer Prostate Cancer

What is this study about?

This study is about an important new treatment for men with advanced prostate cancer that has spread to other parts of the body and is no longer responding to standard hormone treatments. This type of cancer is called "metastatic castration-resistant prostate cancer." Doctors are always looking for more effective treatments that can help men live longer and have a better quality of life.

The new treatment being tested is called Actinium (225Ac) rhPSMA-10.1. It's a special type of radioactive medicine that you get as an injection. The idea is that this medicine will travel through your body and attach specifically to the prostate cancer cells, zapping them with radiation to destroy them. It's similar in concept to Lutetium-PSMA, which some men with prostate cancer might have already had, but this new Actinium treatment uses a different type of radiation that doctors hope might be even more powerful against resistant cancer cells.

The study has two main goals. The first is to find the safest and most effective dose of this new medicine. To do this, some participants will receive different dose levels, and doctors will carefully watch for any side effects. The second goal is to see how well the chosen dose actually treats the prostate cancer in a larger group of men. Researchers will monitor your health, blood tests, and scans to understand how the cancer is responding to the treatment.

Key takeaways

This study is for men with advanced prostate cancer that has spread.
It's testing a new radioactive injection called Actinium (225Ac) rhPSMA-10.1.
The goal is to find a safe dose and see how well it treats the cancer.
Participants will receive the injection every 6 weeks for up to 6 doses.
Regular health checks and scans will monitor your progress and safety.

Who may be eligible?

This study is for adult men, generally aged 18 or older, who have prostate cancer that has spread and is no longer responding to hormone treatments. You would need to have had specific previous treatments, including at least one type of hormone therapy and one or two courses of chemotherapy (or been unable to have chemotherapy).

An important part of joining is that your prostate cancer cells must show up on a special scan called a PSMA-PET-CT scan, which means the treatment could potentially target them. Many participants in this study will also need to have previously received and responded well to a similar radioactive treatment called Lutetium-PSMA. However, a small number of men might be able to join even if they haven't had Lutetium-PSMA before.

Before you can start any treatment in the study, you'll go through a thorough screening process to make sure you meet all the necessary health requirements. This is to ensure the study is safe for you and that the results will be meaningful.

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.

Am I an adult man with prostate cancer that has spread?
Has my prostate cancer stopped responding to hormone treatment?
Have I had specific previous prostate cancer treatments, including hormone therapy and possibly chemotherapy?
Does my cancer show up on a PSMA-PET-CT scan?
Have I previously received (and responded to) Lutetium-PSMA treatment (some exceptions may apply)?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive the study medication, Actinium (225Ac) rhPSMA-10.1, as an injection. You would get one injection every six weeks, for a maximum of six doses, as long as you are tolerating the treatment well and your prostate cancer isn't getting worse.

Throughout the study, you'll have regular check-ups with the study doctors. In the beginning, these might be weekly, sometimes remotely (like a phone call). You'll have blood tests often to monitor your health. Every 12 weeks after starting treatment, you'll have special scans, including a CT scan and a bone scan, to see how your prostate cancer is responding. The total duration of active treatment with the study drug would be about 30 weeks if you receive all six doses, plus a follow-up period afterward.

Potential risks and benefits

Participating in this study might offer a potential benefit if this new drug proves to be an effective treatment for your advanced prostate cancer, especially if other treatments haven't worked well. However, because this is a new medication not previously studied in humans, there are also unknown risks and potential side effects that will be carefully monitored. You will have regular checks, and the research team is there to address any concerns. It's very important to remember that joining a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

University College London Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is Actinium (225Ac) rhPSMA-10.1?

It's a new type of radioactive injection designed to target and destroy prostate cancer cells that have spread, especially in men whose cancer hasn't responded to other treatments.

Why is this treatment needed?

Doctors are looking for better and more effective treatments for advanced prostate cancer that has spread and is no longer responding to standard therapies, to improve patients' outcomes and quality of life.

How often will I receive the treatment?

You would receive an injection every six weeks, for up to a maximum of six doses.

What kind of monitoring will I have?

You'll have regular reviews with doctors, frequent blood tests, and scans (CT and bone scans) every 12 weeks to see how you're doing and how the cancer is responding.

Can I stop participating in the study at any time?

Yes, you are free to withdraw from the study at any point, for any reason, without it affecting your medical care.

How to find out more

Trial Manager

ncita.actinium@ucl.ac.uk 02076799274 Official trial record

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