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Study on Darolutamide and Androgen Deprivation Therapy for Men with Metastatic Hormone-Sensitive Prostate Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of prostate cancer known as metastatic hormone-sensitive prostate cancer (mHSPC). This is a condition where prostate cancer has spread to other parts of the body but still responds to hormone therapy. The study is testing a treatment called darolutamide, which is being used in combination with another treatment known as androgen deprivation therapy (ADT). The trial aims to compare the effectiveness of darolutamide plus ADT against a placebo plus ADT in men with this type of prostate cancer.

The purpose of the study is to determine if darolutamide, when added to ADT, is more effective than a placebo in improving the time patients live without their cancer getting worse, known as radiological progression-free survival. Participants in the study will receive either darolutamide or a placebo, both in addition to ADT. The study will be conducted over a period of time, and participants will be monitored to see how well the treatment works and to track any side effects.

Throughout the study, researchers will also look at other important outcomes, such as overall survival, the time it takes for the cancer to become resistant to treatment, and the time until new cancer treatments are needed. The study will also monitor changes in prostate-specific antigen (PSA) levels, which are used to track prostate cancer progression, and any pain progression experienced by participants. The trial is designed to provide valuable information on the potential benefits of darolutamide for men with metastatic hormone-sensitive prostate cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be asked to provide written informed consent. This means you agree to participate and understand the requirements and restrictions of the study.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes verifying your age, medical history, and current health status. Blood tests and imaging scans may be performed to document the presence of metastatic prostate cancer.
Step 3
Randomization
You will be randomly assigned to one of two groups. One group will receive the study medication, darolutamide, in addition to androgen deprivation therapy (ADT). The other group will receive a placebo along with ADT.
Step 4
Treatment phase
If you are in the darolutamide group, you will take the medication in the form of a film-coated tablet. The dosage and frequency will be determined by the study protocol. The treatment will continue for the duration specified by the study, which may last until the estimated end date in 2025.
If you are in the placebo group, you will take a tablet that looks like the darolutamide tablet but does not contain the active medication. You will also continue with ADT as prescribed.
Step 5
Regular monitoring
Throughout the study, regular monitoring will be conducted. This includes scheduled visits for health assessments, blood tests, and imaging scans to track the progression of the disease and any side effects of the treatment.
Step 6
End of treatment
At the end of the treatment phase, a final assessment will be conducted. This will include a review of your health status and any changes in your condition. The study team will discuss the next steps with you.

Who can join the trial?

10 criteria

Must provide written informed consent, which means you agree to participate in the study and understand what it involves.
If sexually active, male participants must agree to use condoms and not donate sperm during the study and for 4 weeks after. Female partners should use effective birth control.
Must be a male aged 18 years or older.
Must have a confirmed diagnosis of adenocarcinoma of the prostate, which is a type of prostate cancer.
Must have metastatic disease, meaning the cancer has spread to other parts of the body, confirmed by specific imaging tests like bone scans or CT/MRI scans.
Must have started Androgen Deprivation Therapy (ADT), a treatment to lower male hormones, no more than 12 weeks before joining the study. This can include medications or surgery to remove the testicles.
If taking a first-generation anti-androgen, it must be stopped at least 1 day before starting the study treatment.
Must have an ECOG Performance Status of 0, 1, or 2, which is a scale to assess how well you can perform daily activities.
Must have certain blood test results within specific ranges, including hemoglobin, neutrophil count, and platelet count, without recent growth factor treatment or blood transfusions.
Must have liver and kidney function tests within specific limits, including ALT, AST, total bilirubin, and creatinine levels.

Who cannot join the trial?

3 criteria

Patients who do not have **metastatic hormone-sensitive prostate cancer (mHSPC)** cannot participate. This means the cancer has spread to other parts of the body and still responds to hormone therapy.
Only **male** patients can participate in the study.
Patients who are part of a **vulnerable population** cannot participate. This generally refers to groups who may have limited ability to give informed consent or are at higher risk of harm.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Fundacio Puigvert
Verified
Barcelona, Spain
Hospital Universitario Virgen De La Victoria
Verified
Malaga, Spain
Vilniaus universiteto ligonine Santaros klinikos VšĮ
Responsive
Vilnius, Lithuania

Trial locations

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Investigated drugs

Darolutamide
is a medication used in this clinical trial to treat men with metastatic hormone-sensitive prostate cancer. It works by blocking the action of male hormones, like testosterone, which can help slow down the growth of prostate cancer cells. In this study, darolutamide is being tested to see if it can improve the condition of patients when used alongside another treatment called androgen deprivation therapy (ADT).
Androgen Deprivation Therapy (ADT)
is a standard treatment for prostate cancer that aims to reduce the levels of male hormones in the body. These hormones can promote the growth of cancer cells, so lowering their levels can help control the cancer. ADT is often used in combination with other treatments to enhance its effectiveness in managing prostate cancer.

Darolutamide

What is already known about the treatment

Darolutamide – Darolutamide is administered orally in the form of tablets and is currently being studied in clinical trials for its effectiveness in treating metastatic hormone-sensitive prostate cancer (mHSPC). It is used in combination with androgen deprivation therapy (ADT) to potentially improve outcomes for patients with this type of cancer. Darolutamide works by blocking the action of male hormones, which can fuel the growth of prostate cancer cells. It belongs to a class of drugs known as androgen receptor inhibitors, which help to slow down or stop the progression of cancer by interfering with the cancer cells' ability to use hormones for growth.

Investigated diseases

Metastatic hormone-sensitive prostate cancer (mHSPC) – This disease is a type of prostate cancer that has spread to other parts of the body but still responds to hormone therapy. It begins in the prostate gland and can metastasize to bones, lymph nodes, or other organs. The cancer cells in mHSPC are sensitive to androgens, which are male hormones that can promote cancer growth. As the disease progresses, it may lead to symptoms such as bone pain, urinary issues, and fatigue. Over time, the cancer may become resistant to hormone therapy, transitioning to a more advanced stage known as castration-resistant prostate cancer. The progression of mHSPC is monitored through various clinical markers, including prostate-specific antigen (PSA) levels and imaging studies.