AuthorisedTherapeutic exploratory (Phase II)Interventional

Ultra-hypofractionated radiotHErapy and concomitant oral RelugOlix for treatment of intermediate risk prostate cancer. (Ultra-HERO)

The Ultra-HERO study is testing a new approach for men in the UK with intermediate-risk prostate cancer. This type of cancer has grown but is not considered high-risk. The study aims to see how effective a combination of treatments is at lowering a blood marker called PSA, which can indicate the presence of prostate cancer. Participants will receive a very focused, shorter course of radiation therapy (given over 5 sessions) along with a short course of an oral medication called relugolix. Researchers want to know if this combination can lead to a complete biochemical response, meaning their PSA levels drop below a certain point (0.5 ng/ml) after six months. They will also investigate long-term effects, such as how long men stay free of cancer recurrence, how quickly hormone levels return to normal, and the impact on their quality of life.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fondazione Radioterapia Oncologica Onlus

Enrolment target

Start

03 Apr 2025

Intermediate risk prostate cancer

What is this study about?

The Ultra-HERO study is looking into a new way to treat men with prostate cancer that is considered 'intermediate risk'. This means the cancer has grown outside the prostate but not to a very advanced stage. We want to find out if combining a special type of radiation therapy with a short course of a new oral medicine called relugolix works well together.

Radiation therapy uses high-energy rays to kill cancer cells. In this study, we're using 'ultra-hypofractionated' radiation, which means you get fewer, but stronger, doses over a shorter period (just 5 sessions). Relugolix is a tablet you take by mouth that helps lower the amount of male hormones in the body, which can slow down prostate cancer growth.

The main goal is to see if this combined treatment can significantly lower a blood marker called PSA (prostate-specific antigen) in men after six months. A low PSA often means the treatment is working. We will also be watching to see how long men stay cancer-free, how their hormone levels recover, and if there are any effects on their general health and quality of life over two years and beyond. This research is important to find better and potentially more convenient treatments for prostate cancer.

Key takeaways

The Ultra-HERO study tests a new combination treatment for prostate cancer.
It combines a short course of radiation therapy with an oral medication (relugolix).
The main goal is to see if it lowers PSA levels effectively in men with intermediate-risk prostate cancer.
Your general health and quality of life will be carefully monitored.
Participation involves regular check-ups and questionnaires over several years.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

This study is looking for men aged 18 and over who have been diagnosed with intermediate-risk prostate cancer. This specific type of prostate cancer has certain features that place it in the 'intermediate risk' category.

To be eligible, you must be a man and an adult. There isn't an upper age limit mentioned, so doctors will consider all adult men who meet the other criteria.

The doctors will check several specific details about your prostate cancer to make sure it's the right type for this study. They will explain all the details to you to ensure you understand if this study might be a good fit for your situation.

Quick self-check

Am I a man?
Am I 18 years old or older?
Have I been diagnosed with intermediate-risk prostate cancer?
Has my doctor confirmed that my specific prostate cancer meets the study criteria?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would receive a special type of radiation therapy. This involves attending a clinic for 5 radiation sessions, usually over a short period. You would also take an oral medication called relugolix for a short while.

Throughout the study, you would have regular appointments to monitor your progress. These appointments would involve blood tests to check your PSA levels, hormone levels (like testosterone), and general health. You would also be asked to complete questionnaires about your quality of life, sexual function, and any side effects you might experience. These check-ups will continue for at least two years after your treatment finishes, with some aspects potentially followed up for longer. The total duration of your active involvement with assessments would be several years.

Potential risks and benefits

Taking part in this study could offer the potential benefit of a new, potentially more effective treatment for your prostate cancer, combining focused radiation with a new oral medication. The radiation is given in a shorter course, which might be more convenient for some. However, like all medical treatments, there are potential risks and side effects from both the radiation therapy and the relugolix medication. These will be fully explained by the study team, including potential effects on your heart, bones, or sexual function. It is important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Italy

Common questions

What is 'intermediate-risk' prostate cancer?

Intermediate-risk prostate cancer means the cancer has grown within the prostate or slightly outside, but it's not considered low-risk or high-risk. Your doctor can explain why your specific cancer falls into this category.

What is PSA and why is it important?

PSA stands for Prostate-Specific Antigen. It's a protein made by the prostate. High levels can suggest prostate cancer. In this study, doctors are checking if the treatment lowers your PSA significantly.

What is 'relugolix'?

Relugolix is a medicine taken as a pill. It works by reducing the male hormones in your body, which can help slow down the growth of prostate cancer cells.

Will I still get my usual care if I don't join the study?

Yes, absolutely. Your decision about joining a study will not affect the quality of medical care you receive. Your doctor will discuss all available treatment options with you.

How long will I be in the study if I participate?

From starting treatment, you would be monitored for at least two years, with some assessments potentially continuing for longer. The study team will give you a detailed timeline.