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Study on High-Risk Prostate Cancer Treatment Using Darolutamide, Relugolix, and Drug Combination for Eligible Patients

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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 the treatment of prostate cancer, a disease that affects the prostate gland in men. The study will explore the effectiveness of different treatments, including a medication called darolutamide (also known by its code name BAY 1841788), which is an androgen receptor inhibitor. Androgens are male hormones that can promote the growth of prostate cancer cells. The trial will also involve other treatments such as relugolix, leuprorelin acetate, goserelin acetate, degarelix, and docetaxel. These medications work in various ways to manage hormone levels or directly target cancer cells. A placebo will also be used in some parts of the study.

The purpose of the study is to determine if these treatments can improve outcomes for patients with high-risk prostate cancer. The study will be conducted in two parts. The first part will focus on intensifying treatment to see if it can prevent the spread of cancer as detected by a special imaging test called PSMA PET/CT. The second part will look at whether a less intense treatment approach can maintain or improve the quality of life for patients. Participants will receive treatment for up to 96 weeks, which is about 24 months, and their progress will be monitored over time.

Throughout the study, participants will undergo various assessments to track their health and the effectiveness of the treatments. These assessments will include regular imaging tests and questionnaires to evaluate their quality of life. The study aims to provide valuable insights into the best ways to treat high-risk prostate cancer and improve the lives of those affected by this condition.

The research process

The trial runs in 8 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, participation in a clinical trial for high-risk prostate cancer begins. The trial is designed to evaluate new diagnostic and treatment methods.
Step 2
Initial assessment
An initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status, focusing on prostate cancer diagnosis and risk factors.
Step 3
Treatment phase 1
The first phase of treatment involves the administration of Orgovyx 120 mg film-coated tablets, taken orally. This medication is used to manage hormone levels and is taken daily.
Step 4
Treatment phase 2
In the second phase, Docetaxel is administered as an intravenous infusion. This treatment is given every three weeks for a total of six cycles, aiming to target cancer cells directly.
Step 5
Treatment phase 3
The third phase includes the use of Darolutamide, taken orally. This medication is part of a combination therapy to enhance treatment effectiveness and is taken twice daily.
Step 6
Monitoring and follow-up
Regular monitoring through PSMA PET/CT scans is conducted to assess treatment progress. These scans help in detecting any new lesions or changes in the cancer's status.
Step 7
Quality of life assessments
Quality of life is evaluated using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire. This assessment occurs annually to monitor the impact of treatment on daily life.
Step 8
Completion of trial
The trial concludes after the specified treatment period, with a final assessment to evaluate overall health and treatment outcomes. Long-term follow-up may be recommended based on individual needs.

Who can join the trial?

7 criteria

The patient must have **prostate cancer** confirmed by a test called **histopathology**.
The patient must have **high-risk disease**, which means having any of the following: a **PSA** level greater than 20 ng/mL, a **T-stage** of 3 or 4, or a **Gleason score** between 8 and 10. PSA is a protein made by the prostate, T-stage describes the size and extent of the main tumor, and the Gleason score indicates how aggressive the cancer is.
The patient must have an **ECOG Performance Status** of 0 or 1. This is a scale that measures how well a patient can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
The patient must be willing to have a **PSMA PET/CT** scan, which is an imaging test that helps to see cancer spread, with or without a special dye called contrast.
The patient must agree to have their main tumor tested to find out the **Decipher score**, which helps predict the behavior of the cancer.
The patient must be willing to undergo **SOC RT** (standard of care radiation therapy) and long-term **ADT** (androgen deprivation therapy), which may include treatment with **darolutamide** and/or **LHRHA**. ADT is a treatment to lower male hormones that can help prostate cancer grow.
The patient must be male.

Who cannot join the trial?

3 criteria

Only male participants are allowed, so females cannot participate.
Participants must be within certain age ranges, so those outside these ranges cannot join.
Individuals with certain vulnerabilities or special needs are not eligible.

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Verified sites

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

Algemeen Ziekenhuis Delta
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Roeselare, Belgium
Cliniques Universitaires Saint-Luc
Responsive
Woluwe-Saint-Lambert, Belgium
Universitair Ziekenhuis Gent
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Gent, Belgium

Trial locations

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Investigated drugs

Darolutamide
is a medication used in this trial to treat high-risk prostate cancer. It works by blocking the effects of male hormones that can promote the growth of cancer cells. In this study, darolutamide is being tested to see if it can improve the quality of life and effectiveness of treatment when used alongside standard care.
Standard of Care Radiation Therapy (SOC RT)
is a common treatment for prostate cancer that uses high-energy rays to target and kill cancer cells. In this trial, it is used in combination with other treatments to see if it can improve outcomes for patients with high-risk prostate cancer.
Androgen Deprivation Therapy (ADT)
is a treatment that reduces the levels of male hormones in the body to slow down or stop the growth of prostate cancer. It is often used as a standard treatment for prostate cancer and is being compared in this trial to see if adding other therapies can improve patient outcomes.

What is already known about the treatment

Darolutamide – This medication is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating high-risk prostate cancer. Darolutamide is primarily used to manage prostate cancer by blocking the action of male hormones that can promote the growth of cancer cells. It works at the molecular level by inhibiting androgen receptors, which are proteins that bind to male hormones. Darolutamide is classified as an anti-androgen medication, which is a type of hormone therapy used in cancer treatment.

Investigated diseases

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. The prostate is a small gland in men that produces seminal fluid. This cancer often grows slowly and may initially cause no symptoms. As it progresses, it can lead to difficulty urinating, blood in the urine, or pelvic discomfort. In advanced stages, it may spread to bones or other parts of the body. The progression can vary greatly, with some cases remaining localized and others becoming more aggressive.