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Study on Darolutamide with Standard Therapy for Patients with High-Risk Localized 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 treatment for prostate cancer, specifically for cases that are considered very high-risk and localized, meaning the cancer has not spread to other parts of the body. The treatment being tested is a medication called darolutamide, which is taken as a film-coated tablet. The study will compare the effects of adding darolutamide to standard treatments, which include hormone therapy and radiation therapy, against a placebo. The goal is to see if darolutamide can improve outcomes for patients with this type of prostate cancer.

Participants in the study will receive either darolutamide or a placebo, in addition to their regular treatment. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo. This helps ensure that the results are not biased. The main focus of the study is to determine if the treatment can help patients live longer without the cancer spreading, which is referred to as metastasis-free survival.

The study will also look at other important outcomes, such as overall survival, which is the length of time patients live after starting the study, and prostate cancer-specific survival, which is the time patients live without dying from prostate cancer. Additionally, the study will monitor the progression of prostate-specific antigen (PSA) levels, which are used to track prostate cancer, and the time it takes for the cancer to become resistant to hormone therapy. The study will also assess the quality of life of participants and any side effects they may experience during the trial.

The research process

The trial runs in 5 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, the patient will be randomly assigned to receive either the active medication, darolutamide, or a placebo. This process is double-blind, meaning neither the patient nor the researchers know which treatment is being administered.
The medication is provided in the form of a film-coated tablet and is taken orally.
Step 2
Medication administration
The patient will take the assigned medication, either darolutamide or placebo, as part of the study protocol. The specific dosage and frequency will be determined by the study guidelines and communicated to the patient at the start of the trial.
Step 3
Standard therapy
In addition to the study medication, the patient will continue with standard therapy, which includes androgen deprivation therapy and radiation therapy. These treatments are part of the standard care for very high-risk, localized prostate cancer.
Step 4
Monitoring and assessments
Throughout the trial, the patient will undergo regular monitoring and assessments to evaluate health status and treatment effects. This includes blood tests, imaging studies, and other necessary evaluations to track the progression of the disease and any side effects of the treatment.
Step 5
Completion of the trial
The trial is expected to continue until June 2029. Upon completion, the patient's health outcomes will be analyzed to determine the effectiveness of adding darolutamide to the standard therapy for prostate cancer.

Who can join the trial?

10 criteria

Men aged 18 years and older, with a confirmed diagnosis of prostate cancer.
Must have signed a written informed consent form, which means they agree to participate in the study after understanding all the details.
Either planning to receive primary radiation therapy (RT) and considered at very high risk for cancer returning based on specific medical criteria, or have had prostate surgery within the last year and planning for RT with specific PSA levels.
Must have adequate bone marrow function, which means having enough healthy blood cells. This includes hemoglobin levels of at least 100g/L, white cell count of at least 4.0x10⁹/L, absolute neutrophil count of at least 1.5x10⁹/L, and platelets greater than 100x10⁹/L.
Must have adequate liver function, meaning certain liver enzymes and bilirubin levels are within acceptable limits.
Must have adequate kidney function, which is measured by a creatinine clearance greater than 30 mL/min.
Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which indicates they are fully active or have some symptoms but do not need bed rest.
The study treatment must be planned and able to start within 7 days after being assigned to a treatment group.
Must be willing to complete health-related quality of life questionnaires, unless unable to do so due to reading or vision difficulties.
Must be willing and able to follow all study requirements, including standard treatments like external beam radiation therapy (EBRT) and necessary assessments.

Who cannot join the trial?

3 criteria

Patients who do not have localized very high-risk cancer of the prostate cannot participate. This means the cancer is in the prostate and is considered very high risk.
Only male patients are eligible to participate. Female patients cannot join the study.
Patients who are part of a vulnerable population are not allowed to participate. This refers to groups of people who might need special protection or care.

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Verified sites

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Cork University Hospital
Cork, Ireland
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University Hospital Galway
Galway, Ireland

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Investigated drugs

Darolutamide
is a medication being tested in this trial to see if it can improve treatment outcomes for patients with very high-risk, localized prostate cancer. It is being added to standard therapies to determine if it can help prevent the spread of cancer or delay death. Darolutamide works by blocking the effects of male hormones that can promote the growth of prostate cancer cells.
Androgen Deprivation Therapy (ADT)
is a standard treatment for prostate cancer that reduces the levels of male hormones in the body. These hormones can fuel the growth of prostate cancer cells, so lowering their levels can help control the cancer.
Radiation Therapy
is a treatment that uses high-energy rays or particles to kill cancer cells. In this trial, it is used either as a definitive treatment or as a salvage therapy, which means it is given after the cancer has not responded to other treatments. The goal is to target and destroy cancer cells in the prostate and surrounding areas.

Darolutamide

What is already known about the treatment

Darolutamide – Darolutamide is administered orally in tablet form and is currently being studied in clinical trials for its effectiveness in treating localized very high-risk prostate cancer. It is an androgen receptor inhibitor, which means it works by blocking the action of male hormones that can promote the growth of cancer cells. This medication is classified as a non-steroidal antiandrogen and is being evaluated for its potential to improve metastasis-free survival when added to standard androgen deprivation therapy and radiation.

Investigated diseases

Localized Very High-Risk Cancer of the Prostate – This is a form of prostate cancer where the disease is confined to the prostate gland but is considered very high-risk due to factors like high PSA levels, aggressive tumor grade, or extensive tumor involvement. The cancer cells grow and multiply more rapidly than in lower-risk forms, potentially leading to a higher chance of spreading beyond the prostate. As the disease progresses, it may invade nearby tissues or organs, and in some cases, it can spread to distant parts of the body, such as bones or lymph nodes. The progression of this cancer can vary, with some individuals experiencing a slow advancement, while others may see a more rapid progression. Monitoring and management are crucial to prevent metastasis and manage symptoms effectively.