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Study of Darolutamide to Increase PSMA Protein Expression in Patients with Hormone Sensitive Prostate Cancer

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This study involves patients with prostate cancer who are sensitive to hormone treatment. The treatment being investigated is darolutamide, which is also known by its code names ODM-201 and BAY 1841788. Darolutamide belongs to a group of medicines called androgen receptor inhibitors, which work by blocking the effects of male hormones that can help prostate cancer cells grow. The medicine comes in the form of film-coated tablets that are taken by mouth. The purpose of this study is to see whether taking darolutamide causes an increase in a specific protein called PSMA that appears on prostate cancer cells, which could make the cancer more visible on special imaging scans.

During the study, patients will undergo PSMA PET/CT scans, which are special imaging tests that combine two types of scans to find and measure prostate cancer in the body. These scans will be done before starting the treatment and again after taking darolutamide to compare the results. The study will look at whether the number of cancer deposits increases, whether existing cancer spots show higher levels of the PSMA protein, or whether the cancer spots become larger or more visible after treatment with darolutamide. This effect, where the visibility of cancer temporarily increases after starting certain hormone-blocking treatments, is sometimes called a flare phenomenon.

Patients participating in this study will have already received previous treatment for their prostate cancer, either surgery to remove the prostate or radiation therapy, and their scans will show between one and five areas where the cancer has spread to bones or lymph nodes. The study will also collect information about any side effects that occur and how patients feel during the treatment by using quality of life questionnaires. The measurements taken during the scans will include the number of cancer spots, their size, their location in the body, and a measurement called SUVmax which indicates how much the PSMA protein is present in each spot.

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
Baseline imaging scan
At the start of the trial, you will undergo a PSMA PET/CT scan. This is a special imaging test that helps identify cancer deposits in your body.
The scan will record the number of cancer deposits, their size measured in millimeters, and their location. Locations may include lymph nodes, bones, or other areas.
The scan will also measure the SUVmax, which indicates how much of the imaging tracer is absorbed by each cancer deposit. This helps assess the activity level of the cancer.
Step 2
Starting darolutamide treatment
After the baseline scan, you will begin taking darolutamide. This medication is an androgen receptor inhibitor, which means it blocks hormones that can help prostate cancer grow.
The medication comes as film-coated tablets that you take by mouth.
You will take 300 mg of darolutamide. The specific frequency and exact duration of treatment will be determined based on the trial protocol.
Step 3
Follow-up imaging scan
After you have been taking darolutamide for a specified period, you will undergo a second PSMA PET/CT scan.
This scan will be compared to your baseline scan to assess any changes in the cancer deposits.
The scan will evaluate whether new cancer deposits have appeared, whether existing deposits have changed in size or activity level, and whether the total number of deposits has increased.
Step 4
Quality of life assessment
During the trial, you will be asked to complete a questionnaire about your health-related quality of life.
This questionnaire helps assess how the treatment affects your daily activities and overall well-being.
Step 5
Monitoring for side effects
Throughout the trial, any adverse events (side effects or unwanted reactions) will be recorded.
This includes both minor side effects and serious adverse events that may require medical attention.
All side effects will be documented according to standardized medical criteria to ensure your safety is monitored.

Who can join the trial?

11 criteria

You must be an adult man over 18 years of age
You can have any level of PSA, which is a protein in the blood that can indicate prostate problems, and any grade or stage of your disease
Your prostate cancer must have been confirmed by examining tissue under a microscope, which is called a histological confirmation
Your general health and ability to perform daily activities must be good, rated as ECOG 0-1, which means you are fully active or able to carry out light work
Your doctor must expect that you will live longer than 12 months
You must not have received any previous hormonal therapy, which are treatments that affect male hormones like testosterone, including medicines such as bicalutamide, apalutamide, abiraterone or enzalutamide
You must not have received previous chemotherapy with taxane-based drugs, which are docetaxel or cabazitaxel
You must be able to read and understand the patient information form
You must sign a document showing you agree to participate in the study, called informed consent
You must have had previous treatment with either robot-assisted surgery to remove the prostate or external beam radiotherapy, which is radiation treatment from outside the body
Your PSMA PET/CT scan, which is a special imaging test that shows prostate cancer cells, must show between 1 and 5 areas where cancer has spread to bones or lymph nodes

Who cannot join the trial?

1 criterion

The study does not list specific reasons why patients cannot participate. Please discuss with your doctor whether this study is suitable for you based on your individual health situation.

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Amsterdam UMC
Amsterdam, The Netherlands

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Investigated drugs

Darolutamide is a medication that blocks the effects of male hormones called androgens in the body. It is used to treat prostate cancer by preventing these hormones from helping cancer cells grow. In this trial, researchers want to see if darolutamide can increase the levels of a specific protein called PSMA on cancer cells, which could make the cancer easier to detect and potentially treat.

Darolutamide

What is already known about the treatment

Darolutamide – Darolutamide is an oral medication taken by mouth that belongs to a class of drugs called androgen receptor inhibitors, which work by blocking the effects of male hormones (androgens) that can fuel the growth of prostate cancer cells. It is an approved treatment used in clinical practice for patients with prostate cancer, particularly in cases where the cancer has not spread or is hormone-sensitive. The drug works at the molecular level by attaching to androgen receptors on cancer cells and preventing testosterone and other male hormones from binding to these receptors, thereby stopping the signals that tell cancer cells to grow and multiply. This medication is being studied in this trial to see if it can increase the visibility of prostate cancer cells on special imaging scans by raising the levels of a protein called PSMA on the surface of cancer cells.

Investigated diseases

Prostate Cancer – Prostate cancer is a disease that occurs when abnormal cells develop in the prostate gland, which is part of the male reproductive system. The prostate is a small gland located below the bladder that produces fluid for semen. In this condition, cells in the prostate begin to grow uncontrollably and can form tumors. As the disease progresses, cancer cells may spread beyond the prostate to nearby tissues such as lymph nodes. In more advanced stages, the cancer can spread to distant parts of the body including bones and other organs, which is called metastatic disease. The progression from localized disease to widespread metastatic disease varies among patients.