Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Stereotactic body radiotherapy with or without Darolutamide for OligoRecurrent prostate cancer: a randomized phase II trial (DART).

This study, called DART, is for men whose prostate cancer has returned in a limited number of spots after earlier treatment. This is known as 'oligo-recurrent prostate cancer.' Researchers want to see if combining a special type of radiation called Stereotactic Body Radiotherapy (SBRT) with a drug called Darolutamide is more effective than SBRT alone. SBRT is a powerful, focused type of radiation. Darolutamide is a medication that works against prostate cancer. The main goal is to find out if this combination can help keep the cancer from spreading to other parts of the body for longer. They will also look at other things like how well people feel and how safe the treatments are.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Universitair Ziekenhuis Gent

Enrolment target

140

Start

09 Apr 2024

OligoRecurrent prostate cancer

What is this study about?

This research study, called DART, is investigating a new treatment approach for prostate cancer that has come back in a limited number of areas after previous treatment. This situation is sometimes known as 'oligo-recurrent' prostate cancer. When cancer returns in this way, doctors want to find the best ways to stop it from spreading more widely.

Currently, one common treatment for this is Stereotactic Body Radiotherapy (SBRT). This is a very precise form of radiation that delivers high doses to the small areas of cancer while trying to protect healthy tissues nearby. This study wants to see if adding a new drug, Darolutamide (also known as BAY 1841788), to SBRT can improve outcomes for patients.

Darolutamide is a type of medicine designed to block hormones that can help prostate cancer grow. By combining it with focused radiation, researchers hope to achieve a stronger and longer-lasting effect against the cancer, potentially preventing it from spreading further and improving patients' quality of life. The main aim is to see if the cancer can be kept from spreading for a longer time.

Key takeaways

Targets prostate cancer that has returned in a few spots.
Tests if combining special radiation (SBRT) with a drug (Darolutamide) works better than SBRT alone.
Aims to stop the cancer from spreading further.
Involves regular check-ups and monitoring.
Participants will be randomly assigned to one of two treatment groups.

Who may be eligible?

This study is open to men aged 18 and over. You would need to have been diagnosed with prostate cancer that has come back in a small number of spots after your initial treatment. This means the cancer hasn't spread widely throughout your body.

To be considered, your doctors would need to confirm that your specific type of prostate cancer and your overall health meet certain criteria. These are checked carefully to make sure the study is right for you and that the results will be clear. For example, they will look at your previous treatments and your general health condition.

It's important to discuss your full medical history with the study team to see if you might be a good fit. They will explain all the specific requirements in detail.

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?
Has your prostate cancer come back in only a few specific areas?
Are you able to take part in regular appointments and scans?
Have you discussed your interest with your doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a number of tests. These might include scans, blood tests, and physical examinations to confirm you are suitable. Once enrolled, you would receive either Stereotactic Body Radiotherapy (SBRT) alone, or SBRT along with the study drug, Darolutamide.

The SBRT treatment involves several focused radiation sessions, usually over a few days or weeks. If you receive Darolutamide, you would take it as a tablet for a period of time. You would have regular check-ups, which include repeat scans, blood tests, and appointments with the study team. These visits are important for monitoring your health and checking how well the treatment is working. This follow-up will continue for several years to track the long-term effects of the treatments. The total duration of your involvement could be several years.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new combination treatment that could be more effective in controlling your prostate cancer. You would also have very close medical monitoring. However, there are potential risks, including side effects from the radiation or the study drug. These side effects can vary from person to person and will be fully explained to you. You are free 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.

—
Unverified
Belgium

Common questions

What is 'oligo-recurrent prostate cancer'?

This means your prostate cancer has come back in a small, limited number of spots in your body after you've already had treatment for it.

What is SBRT?

SBRT stands for Stereotactic Body Radiotherapy. It's a very precise type of radiation treatment that delivers high doses to specific cancer spots while trying to protect healthy tissue.

What is Darolutamide?

Darolutamide is a medicine taken as a pill. It works by blocking male hormones that can make prostate cancer grow.

Will I definitely get the new drug?

This is a 'randomised' study, meaning a computer will randomly decide whether you get SBRT alone or SBRT plus Darolutamide. You won't know which group you're in until after you start treatment.

How long will I be in the study?

Your active treatment and follow-up in the study will last for several years, as doctors need to track the long-term effects of the treatment.