Active not recruitingPHASE3INTERVENTIONAL

Trial Comparing Irradiation Plus Long Term Adjuvant Androgen Deprivation With GnRH Antagonist Versus GnRH Agonist Plus Flare Protection in Patients With Very High Risk Localized or Locally Advanced Prostate Cancer

This study is for men with very high-risk prostate cancer that hasn't spread. It compares two hormone therapies, one called degarelix (a GnRH antagonist) and another standard GnRH agonist, used alongside radiation treatment. Researchers want to know if degarelix is better at preventing the cancer from progressing (getting worse, spreading, or coming back) than the usual hormone therapy. The study will also look at side effects, heart health, and quality of life. The goal is to find the most effective treatment combination to help men with this type of prostate cancer live longer and with a better quality of life.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Enrolment target

885

Start

25 Sep 2017

Estimated completion

30 Jun 2026

Prostate Cancer

What is this study about?

This important study is investigating new ways to treat very high-risk prostate cancer that is still contained within the prostate or has only spread nearby, not to distant parts of the body. If you or someone you know has this type of cancer, hormone therapy is often used to lower the amount of male hormones (like testosterone) that can make the cancer grow. This study combines hormone therapy with radiation treatment, which uses high-energy rays to kill cancer cells.

The main aim of the study is to compare two different types of hormone therapy when given with radiation. One is a newer treatment called degarelix, and the other is a standard hormone therapy. Researchers want to see if degarelix, along with radiation, is more effective at preventing the cancer from growing, spreading, or coming back. This is called 'progression-free survival'. Ultimately, they hope to find the best possible treatment for men with this challenging form of prostate cancer.

Besides looking at how well the treatments work, the study will also carefully check for side effects and how treatments affect a man's quality of life, including urinary health. They will pay special attention to heart health, especially for men who might already be at risk for heart problems, to understand if one treatment type has different effects on the heart. Finding a treatment that is not only effective but also has fewer side effects and a better impact on daily life is a key goal.

Key takeaways

This study is for men with specific types of advanced prostate cancer that hasn't spread far.
It compares two kinds of hormone therapy (degarelix vs. standard) given with radiation treatment.
The main goal is to see which treatment combination is better at preventing the cancer from getting worse.
Researchers will also check for side effects, heart health, and impact on quality of life.
Treatments will last at least 18 months, with regular check-ups.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for men aged 18 to 80 years old who have prostate cancer that's considered 'very high risk' but hasn't spread to distant parts of the body. To be in the study, your prostate cancer needs to be confirmed by a biopsy. It also needs to meet certain criteria, such as specific levels of a marker called PSA, or particular findings from scans or biopsies that indicate it's aggressive or locally advanced.

You cannot have had previous hormone therapy for your prostate cancer, though some other medications (5-alpha reductase inhibitors) might be allowed if you stopped them more than 6 months ago. Your kidneys need to be working well, and your general health should be good enough for you to take part in the study treatments.

The study team will review all your medical information to make sure it's safe and appropriate for you to join. If you have certain heart conditions or allergies to the study drugs, you wouldn't be able to participate. It's crucial to discuss all your health conditions and medications with your doctor to see if this study is an option for you.

Quick self-check

Are you a man between 18 and 80 years old?
Do you have prostate cancer confirmed by a biopsy?
Has your doctor told you your prostate cancer is 'very high risk' but hasn't spread to distant parts of your body?
Have you not had hormone therapy for prostate cancer before?
Do you have good overall health and kidney function?

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'll be randomly assigned to one of two treatment groups, meaning a computer will decide whether you get the new hormone treatment (degarelix) or the standard hormone treatment alongside radiation. Both groups will receive radiation therapy, which typically involves daily sessions, five days a week, for a set period.

The hormone therapy will last for at least 18 months, but your doctor will decide if it needs to be 18, 24, or 36 months long at the beginning of the study. You'll receive degarelix as injections under the skin, initially two injections on day one, then one injection every 28 days. You will have regular appointments for check-ups, blood tests, and scans to monitor your cancer, side effects, and general health. You may also be asked to fill out questionnaires about your quality of life and urinary symptoms. Your overall participation will involve these regular visits and treatments for the duration of your hormone therapy, plus follow-up appointments.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to new or different treatments that are not yet widely available, and close monitoring by a specialist medical team. However, there are also potential risks involved. You might experience side effects from the treatments, which could range from mild to severe, and some might not be known yet. There's also no guarantee that the treatment will be effective for your cancer. You are free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (39)

Hopitaux Universitaires Bordet-Erasme - Hopitaux Universitaires Bordet- Institut Jules Bordet
Brussels, Belgium
Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme
Brussels, Belgium
Universitair Ziekenhuis Brussel
Brussels, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Hopital De Jolimont
Haine-Saint-Paul, Belgium
AZ Groeninge Kortrijk - Campus Kennedylaan
Kortrijk, Belgium
CHU Ucl Namur - Site Sainte-Elisabeth
Namur, Belgium
Gasthuiszusters van Antwerpen - GasthuisZusters Antwerpen - Sint-Augustinus
Wilrijk, Belgium
University Hospitals Copenhagen - Rigshospitalet
Copenhagen, Denmark
Clinique de l'Europe
Amiens, France
Centre de radiotherapie Marie Curie
Arras, France
Centre D'Onco. & Radioth. De Haute Energie Du Pays Basque
Bayonne, France

+27 more sites — see the official record for the full list.

Common questions

What is 'very high-risk localized or locally advanced prostate cancer'?

This means the cancer is aggressive or has grown beyond the prostate, but hasn't spread to distant parts of the body like bones or other organs.

What is hormone therapy and how does it work?

Hormone therapy lowers male hormones (like testosterone) in your body. Prostate cancer often uses these hormones to grow, so reducing them can slow or stop the cancer's growth.

What is 'randomly assigned'?

This means you'll be put into one of the treatment groups by chance, like flipping a coin. Neither you nor your doctor can choose which group you're in.

Will I know which treatment I'm receiving?

Yes, this is an 'open-label' study, meaning both you and your doctors will know which specific treatment you are getting.

What are the main things the researchers want to find out?

They mainly want to know if the newer hormone treatment (degarelix) combined with radiation is better at stopping the cancer from progressing compared to standard hormone therapy with radiation.