Study comparing darolutamide versus hormone therapy (goserelin, leuprorelin, triptorelin, degarelix) in men with untreated hormone-sensitive prostate cancer

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What is this study about?

This study focuses on patients with Hormone Naive Prostate Cancer. The research compares two different treatment approaches: a new medication called darolutamide (also known as BAY 1841788) taken as oral tablets versus standard hormone therapy known as androgen deprivation therapy (ADT). The ADT medications used in the study include degarelix, leuprorelin, triptorelin, and goserelin, which are given either as injections under the skin or into muscle.

The purpose of this study is to determine if darolutamide can lower prostate-specific antigen (PSA) levels as effectively as standard hormone therapy after 24 weeks of treatment. The study will also look at how these treatments affect symptoms related to prostate cancer and monitor the safety of both treatment approaches.

During the study, patients will be randomly assigned to receive either darolutamide tablets or one of the standard hormone therapy medications. The treatment period lasts for 24 weeks, during which patients will have regular check-ups to measure PSA levels and assess their response to treatment. The study will also track any side effects and changes in quality of life that patients may experience during treatment.

1 Initial treatment assignment

You will be randomly assigned to one of two treatment groups: either darolutamide tablets or androgen deprivation therapy (ADT).

The treatment period will last for 24 weeks (approximately 6 months).

2 Medication administration – Group 1 (Darolutamide)

If assigned to the darolutamide group, you will take film-coated tablets by mouth.

The tablets must be swallowed whole.

3 Medication administration – Group 2 (ADT)

If assigned to the ADT group, you will receive hormone therapy through injections.

The medication will be administered either under the skin or into a muscle.

The medications may include: leuprorelin, triptorelin, goserelin, or degarelix.

4 Monitoring and assessments

Your PSA levels (prostate-specific antigen, a blood test) will be measured throughout the study.

The main assessment will occur at week 24 to measure how well the treatment is working.

Your quality of life and any treatment-related symptoms will be evaluated using questionnaires.

Regular safety assessments will be conducted to monitor for any side effects.

5 Final evaluation

At week 24, a final assessment will determine if your PSA levels have decreased by 80% or more compared to the start of the study.

The study team will evaluate any changes in your symptoms and overall response to treatment.

Who Can Join the Study?

Must be 18 years or older
Must be able to swallow tablets whole
Must have adequate bone marrow function, including:
- Sufficient white blood cells (neutrophil count ≥ 1.5)
- Sufficient red blood cells (hemoglobin ≥ 10.0)
- Sufficient platelets (≥ 100)
Must have normal kidney function (creatinine levels within specified limits)
Must have sufficient protein levels in blood (albumin > 25)
Must have normal liver function tests
Must have normal heart rhythm test (ECG)
Must use effective birth control during treatment and for 3 months after
Must be able to comply with study visits and follow-up schedule
Must provide written informed consent
Must have confirmed prostate cancer diagnosis through tissue examination
Must have either no spread of cancer or no more than 4 confirmed areas where cancer has spread (excluding internal organs)
Must have no symptoms from prostate cancer (urinary symptoms are allowed)
Must have normal testosterone levels (≥ 230 ng/dL)
Must have two PSA blood test results ≥ 2, taken at least 2 weeks apart within the past 3 months
Must be able to perform normal daily activities (WHO performance status 0-1)
If 70 years or older, must have a satisfactory health assessment score (G8 score ≥ 14)
Must have a life expectancy of at least 12 months

Who Cannot Join the Study?

Previous treatment with any androgen deprivation therapy (ADT) – medications that reduce male hormone levels
Previous treatment with chemotherapy for prostate cancer
Age below 18 years
Female gender (study is for male patients only)
Known allergies or hypersensitivity to the study medication or its components
Presence of metastatic disease (cancer that has spread to other parts of the body)
Significant heart conditions or uncontrolled high blood pressure
Active or chronic liver disease
Severe kidney problems
Participation in another clinical trial within 30 days before starting this study
Any condition that, in the opinion of the study doctor, would make participation unsafe
Unable to understand or sign the informed consent form
History of seizures or conditions that may increase seizure risk
Current use of medications that could interfere with the study treatment

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Centr Georges Francois Leclerc	Dijon	France
Hospital Universitario De Salamanca	Salamanca	Spain
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Universitair Ziekenhuis Gent	Gent	Belgium
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur	Namur	Belgium
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Cevstwvei Uejxurughcbjno Sfbefcadm	Woluwe-Saint-Lambert	Belgium
Asvyvep Oitkrvnwxjn Uvwdiqdoytsro Cmjfjcwmavby Dugyo Sxvhvi E Dlzvg Sbpvhbs Dd Tpzmcw	Turin	Italy
Icgabaul Czomgj Dxxayewotwglltppp	L'hospitalet De Llobregat	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.06.2017
France	Not recruiting	01.06.2017
Italy	Not recruiting	01.06.2017
Spain	Not recruiting	01.06.2017

Trial locations

Investigated drugs:

Darolutamide
A medication used to treat prostate cancer. It works by blocking the effects of male hormones (androgens) in the body, which can help slow down or stop the growth of prostate cancer cells.

LHRH agonists
These medications are hormone therapy drugs that reduce testosterone levels in the body. They work by initially stimulating and then suppressing the production of testosterone, which can help control prostate cancer growth.

LHRH antagonist
A type of hormone therapy that works by immediately blocking the production of testosterone without the initial stimulation seen with LHRH agonists. This medication helps control prostate cancer by reducing male hormone levels in the body.

Investigated diseases:

Hormone-dependent prostate cancer

Hormone Naive Prostate Cancer – A condition where prostate cancer cells have not yet been exposed to hormone therapy treatments. The cancer begins in the prostate gland and grows in response to male hormones (androgens) like testosterone. It develops when cells in the prostate start to grow uncontrollably, forming tumors within the gland. The disease is characterized by elevated levels of prostate-specific antigen (PSA) in the blood. As the condition progresses, the cancer cells continue to rely on androgens for their growth and survival.

Trial ID:

2024-510840-30-00

NCT ID:

NCT02972060

Trial Phase:

Therapeutic exploratory (Phase II)

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Study comparing darolutamide versus hormone therapy (goserelin, leuprorelin, triptorelin, degarelix) in men with untreated hormone-sensitive prostate cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?