Not yet recruitingPHASE2INTERVENTIONAL

Study of Radiation Therapy in Combination With Darolutamide + Degarelix in Intermediate Risk Prostate Cancer

This study investigates a new treatment approach for men with intermediate-risk prostate cancer. Currently, treatment can vary, and it's hard to predict who needs more intensive care. This trial combines standard radiation therapy with a powerful new hormone therapy package (darolutamide, a new drug, plus degarelix, an approved drug). Researchers want to find out if this combination is more effective than radiation alone in preventing the cancer from coming back or spreading. They believe certain features of the cancer cells might help identify men who would benefit most from this extra treatment. All participants will receive radiation, but some will also get the hormone therapy, and they will be followed for five years to see the results.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

University Health Network, Toronto

Enrolment target

208

Start

02 Jul 2024

Estimated completion

01 Dec 2028

Prostate Cancer

What is this study about?

Prostate cancer is very common in men, and for some, it's considered 'intermediate risk.' This means the cancer hasn't spread, but its future behaviour can be unpredictable. Standard treatment often involves radiation therapy, sometimes with hormone therapy. While this can cure some men, the cancer can unfortunately return or spread in others. This uncertainty means some men might get too much treatment, while others might not get enough.

This study wants to improve how we treat intermediate-risk prostate cancer. Researchers are testing if adding a strong hormone therapy combination, featuring a new drug called darolutamide and an existing drug called degarelix, to standard radiation therapy is more effective than radiation alone. Darolutamide works by blocking male hormones like testosterone, which prostate cancer cells need to grow. Degarelix also reduces these hormones. The hope is that this intensive combination will prevent the cancer from returning or spreading after radiation.

The study also aims to identify which men might benefit most from this more intensive treatment. Doctors currently find it hard to tell who needs extra help. The researchers believe that looking at specific features of the cancer cells, like their arrangement (called 'intraductal carcinoma') and a genetic marker (called 'SChLAP1'), could help pinpoint who would respond best to the added hormone therapy. All participants will get radiation, but half will also receive the extra hormone treatment, allowing researchers to compare the outcomes.

Key takeaways

The study tests a new hormone therapy combination (darolutamide + degarelix) with radiation for intermediate-risk prostate cancer.
It aims to see if this combined approach is better than radiation alone.
Researchers hope to identify specific cancer cell features that predict who benefits most from the extra treatment.
Participants will receive either radiation plus hormone therapy or radiation alone, and will be followed for 5 years.
Darolutamide is a new, experimental drug that blocks male hormones.
Participation involves regular check-ups to monitor safety and effectiveness.

Who may be eligible?

To be considered for this study, you must be a man aged 18 or older with a confirmed diagnosis of intermediate-risk prostate cancer within the last six months. Your cancer must not have spread to your bones or other parts of your body. You will also need to meet specific health criteria, such as having healthy blood counts and kidney function.

Crucially, only men whose prostate cancer cells either *both* show a specific arrangement (intraductal carcinoma) *and* have a particular genetic marker (SChLAP1), or *both* do *not* have these features, can take part. This helps the researchers understand the effect of the treatment on certain prostate cancer types.

You cannot join if you've already received hormone therapy for your prostate cancer, or other treatments like chemotherapy, in the past year. Also, if you're taking medications that might react badly with the study drugs, you wouldn't be able 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 over?
Do you have intermediate-risk prostate cancer that hasn't spread?
Has your prostate cancer diagnosis been confirmed within the last 6 months?
Have you *not* had hormone therapy or chemotherapy for prostate cancer in the last year?
Do you have a general good health status, including healthy blood counts and kidney function?
Do your cancer cells show either *both* specific features (intraductal carcinoma and SChLAP1) or *neither* of them?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to one of two groups: either you will receive standard radiation therapy plus hormone therapy (darolutamide and degarelix), or you will receive radiation therapy only. The radiation therapy typically lasts about 1-2 weeks. If you are in the hormone therapy group, you will take those medications for 6 months.

All participants will be carefully monitored for 5 years after their treatment. This will involve multiple follow-up visits to assess how safe the treatment is and how well it is working. These visits will include checks on your health and tests to see if the cancer has returned or spread.

Potential risks and benefits

Participating in this study might offer a potential benefit if the combination of radiation and hormone therapy proves more effective than radiation alone in preventing your prostate cancer from returning or spreading. However, adding more treatments can also increase the risk of side effects. Darolutamide is a new drug, and while initial studies have been promising, it is still considered experimental. Degarelix is an approved drug, but like all medications, it has its own set of potential side effects. You will be closely monitored for any health changes, and you have the right to withdraw from the study at any time for any reason.

Locations (1)

UHN Princess Margaret Hospital
Verified postcode
Toronto, Canada

Common questions

What is 'intermediate-risk' prostate cancer?

It means the cancer hasn't spread, but it has certain features that suggest it might be more likely to grow or spread than very low-risk cancers, making its future behaviour a bit uncertain.

What is darolutamide?

Darolutamide is a new medication that blocks male hormones. Prostate cancer usually needs these hormones to grow, so blocking them can help stop the cancer.

Why are some men getting extra hormone therapy and others not?

The study aims to compare the two approaches. By having a group that receives the extra hormone therapy and a group that doesn't, researchers can determine if the added treatment is truly more effective.

What are 'intraductal carcinoma' and 'SChLAP1'?

These are specific features found in some prostate cancer cells. Researchers believe they might help identify men who would benefit most from more intensive treatment.

How long will the study last for me?

The active treatment period (radiation and potentially hormone therapy) is relatively short, but you will be followed by the study team for a total of 5 years to monitor your health and the treatment's long-term effects.

How to find out more

Sunakshi Chowdhary

sunakshi.chowdhary@uhn.ca 416-946-4501 Official trial record

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