AuthorisedPhase I and Phase II (Integrated)- OtherInterventional

Clinical Application of the Androgen Receptor Inhibitor Darolutamide to Upregulate the Prostate-Specific Membrane Antigen (PSMA) Protein Expression in Patients with Hormone Sensitive Prostate Cancer. - The DARO-flare Trial -

The DARO-flare study is investigating how a drug called NUBEQA (darolutamide), which is already used to treat advanced prostate cancer, might help with earlier-stage prostate cancer. Specifically, researchers want to see if NUBEQA makes certain cancer cells more visible on a special type of scan called a PSMA PET/CT scan. This scan helps doctors find prostate cancer cells in the body. If NUBEQA can "light up" these cells more, it could help doctors get a clearer picture of where the cancer is and how much there is. This information might then help them decide on the best treatment plan for individual patients. The study is for men with prostate cancer and is in its early stages of testing.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Amsterdam UMC Stichting

Enrolment target

Start

04 Dec 2025

Prostate cancer

What is this study about?

The DARO-flare study is looking into a medication called NUBEQA, which is currently approved for men with advanced prostate cancer. This study, however, is exploring a new potential use for NUBEQA in men with earlier stages of prostate cancer. The main idea behind this research is to see if NUBEQA can make cancer cells, particularly a protein on their surface called PSMA, more noticeable during a special type of scan called a PSMA PET/CT. Think of PSMA as a signpost on the cancer cell that these scans are designed to detect.

By making these PSMA signposts stand out more, doctors hope to get a better and more accurate view of where the cancer is located, how many cancer spots there are, and how big they are. This is very important because a clearer picture of the cancer can help doctors make more informed decisions about the best way to treat each patient. For example, knowing exactly where the cancer has spread, even small spots, can guide treatment choices more effectively.

This study aims to discover if NUBEQA could be a useful tool to improve how we find and track prostate cancer in men who have not yet reached the advanced stages. If successful, it could lead to more precise diagnosis and treatment planning for many men with prostate cancer in the future.

Key takeaways

The study tests if NUBEQA helps doctors see prostate cancer better on scans.
It's for men with prostate cancer, aged 18 and over.
Participation involves taking tablets and having regular scans.
The goal is to improve how prostate cancer is found and assessed.
Your health and safety are carefully monitored throughout the study.

Who may be eligible?

This study is looking for men aged 18 or older who have prostate cancer.

To be considered, you will need to meet specific health criteria related to your prostate cancer, which the study doctors will check carefully. This includes looking at your past medical history and current health status.

If you are interested in taking part, the study team will review all your medical details to make sure the study is a safe and appropriate option for 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 male?
Are you 18 years old or older?
Have you been diagnosed with prostate cancer?
Are you generally able to take oral medication (pills)?
Are you able to attend clinic appointments and scans regularly?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the study drug, NUBEQA, as 300 mg tablets to take. You will have regular PSMA PET/CT scans to monitor your prostate cancer. These scans will help the doctors see if there are any changes in the number, size, and location of your cancer spots over time. You will also have various other tests, such as blood tests and physical examinations, at different points throughout the study. We expect you will need to attend several clinic visits for these assessments and to discuss how you are feeling. The exact number of visits and the total duration of your participation will be explained in detail by the study team.

Potential risks and benefits

Taking part in this study might offer potential benefits, such as receiving a new approach to help doctors see your cancer more clearly, which could inform your treatment. However, as with any medication, there are potential risks, including side effects from NUBEQA. These will be fully explained to you before you consent to participate. 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.

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Unverified
Netherlands

Common questions

What is PSMA PET/CT?

It's a special scan used to find prostate cancer cells by looking for a protein called PSMA on their surface.

What is NUBEQA?

NUBEQA is a medication currently used to treat advanced prostate cancer. This study is looking at a new way it might help earlier-stage cancer.

Will I still get my regular prostate cancer treatment?

This study is aimed at understanding a specific effect of NUBEQA. Your doctors will discuss how this fits with your overall treatment plan.

What are the main goals of this study?

The study aims to see if NUBEQA can make prostate cancer easier to see on scans and understand how it affects the cancer's appearance.

How long will the study last for me?

The study team will give you a detailed timeline when you inquire, as it can vary for each participant based on their specific situation.