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Study on the Effect of Degarelix on Prostate-Specific Membrane Antigen in Patients with Untreated Metastatic 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 metastatic prostate cancer, a type of cancer that has spread from the prostate to other parts of the body. The treatment being investigated is called degarelix, which is a synthetic hormone blocker that prevents the release of certain hormones that can promote cancer growth. The purpose of the study is to observe how this treatment affects a specific protein found in prostate cancer cells, known as the prostate-specific membrane antigen (PSMA).

Participants in the study will receive the treatment and be monitored over time to see how the cancer responds. The study will look at changes in PSMA levels, particularly in bone lesions compared to prostate lesions, after starting the treatment. This will help researchers understand if the treatment causes a noticeable change in PSMA levels, which could indicate how the cancer is reacting to the therapy.

Throughout the study, additional tests such as PET scans will be used to track the cancer's progression and response to the treatment. Researchers will also explore other aspects, such as changes in hormone levels and the gut microbiome, which is the collection of bacteria and other microorganisms in the digestive system, during the course of the treatment. The study aims to provide valuable insights into the effectiveness of degarelix in treating metastatic prostate cancer and its impact on PSMA expression.

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
Initiation of treatment
The treatment begins with the administration of degarelix, a medication used to manage prostate cancer. It is given through a subcutaneous injection, which means it is injected under the skin.
The initial dose is administered to start the androgen deprivation therapy (ADT), which aims to reduce the levels of male hormones that can promote the growth of prostate cancer cells.
Step 2
Monitoring period
After the initiation of treatment, the patient is monitored for a period of 2 to 3 weeks. During this time, the focus is on observing the expression of prostate-specific membrane antigen (PSMA) in cancerous lesions.
The primary goal is to determine if there is a PSMA-flare, which is an increase in PSMA expression, particularly in bony lesions compared to prostatic lesions.
Step 3
Follow-up assessments
Regular follow-up assessments are conducted to evaluate the behavior of metastatic lesions with and without PSMA-flare. This involves repeated imaging tests, such as 18F-PSMA-PET CT scans, to monitor changes over time.
Additional studies may include comparing the metastatic load seen in different imaging techniques and determining the total androgen profile every six months from diagnosis to the development of castration-resistant prostate cancer (CRPC).
Step 4
Biopsy and analysis
Biopsies of prostate lesions may be performed to determine if changes in PSMA uptake after ADT have a histopathological correlation. This involves taking small samples of tissue for detailed examination.
The study also investigates the gut microbiome and its changes during ADT, which may provide insights into the overall impact of the treatment on the patient's health.
Step 5
Completion of trial
The trial is expected to continue until December 31, 2026. Throughout the trial, the patient's health and response to treatment are closely monitored to ensure safety and effectiveness.
Upon completion, the collected data will contribute to a better understanding of the effects of ADT on PSMA expression and the progression of metastatic prostate cancer.

Who can join the trial?

9 criteria

Age: You must be between 40 and 85 years old.
Language: You need to speak Finnish or Swedish.
Diagnosis: You must have a confirmed diagnosis of **adenocarcinoma of the prostate**, which is a type of prostate cancer.
Biopsy: You need to have had enough tissue samples taken, with at least 3 samples from each side of the prostate.
Treatment History: You should not have had any previous surgery, radiation, or hormone treatment for prostate cancer.
Clinical Stage: Your cancer should be at a stage between **T1c** and **T4**, with any **N** (lymph node involvement) and **M1** (cancer has spread to other parts of the body).
Kidney Function: Your **serum creatinine** level, which is a measure of kidney function, should be no more than 1.5 times the upper limit of normal.
Mental Status: You must be able to understand what the study is about.
Consent: You need to sign a consent form that has been approved by an Ethical Committee, in front of the designated staff.

Who cannot join the trial?

3 criteria

Only male participants are allowed. Female participants cannot join the study.
Participants must have metastatic prostate cancer or prostate cancer. If you do not have these conditions, you cannot participate.
The study is not open to vulnerable populations. This means people who might need special protection or care are not included.

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Turku University Hospital
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Turku, Finland

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Investigated drugs

Androgen Deprivation Therapy (ADT) is a treatment used to reduce levels of male hormones, called androgens, in the body. These hormones can stimulate the growth of prostate cancer cells. By lowering androgen levels, ADT helps to slow down or stop the growth of cancer. This therapy is often used in patients with metastatic prostate cancer, which means the cancer has spread to other parts of the body. The goal of ADT in this trial is to observe its effect on the expression of prostate-specific membrane antigen (PSMA) in patients who have not received prior treatment for their metastatic prostate cancer.

Degarelix

What is already known about the treatment

Androgen Deprivation Therapy (ADT) – This treatment is typically administered through injections or oral medications and is used to lower levels of male hormones that can fuel the growth of prostate cancer cells. Currently, ADT is a well-established treatment in medical practice and literature for managing prostate cancer, particularly in cases where the cancer has spread beyond the prostate. The main therapeutic indication for ADT is metastatic prostate cancer. At the molecular level, ADT works by reducing the production of androgens or blocking their effect on prostate cancer cells, thereby slowing the growth of the cancer. It is classified pharmacologically as a hormone therapy.

Investigated diseases

Metastatic Prostate Cancer
This is a type of prostate cancer that has spread beyond the prostate gland to other parts of the body, such as bones or lymph nodes. It often progresses from localized prostate cancer when cancer cells travel through the bloodstream or lymphatic system. The disease can cause symptoms like bone pain, urinary issues, and fatigue. As it advances, it may affect various organs and systems, leading to more complex symptoms. The progression can vary greatly among individuals, with some experiencing rapid changes and others having a slower course. Monitoring and understanding the spread is crucial for managing the disease effectively.
Prostate Cancer
This is a common cancer that begins in the prostate gland, which is part of the male reproductive system. It often grows slowly and may initially cause no symptoms. As it progresses, it can lead to urinary difficulties, blood in the urine, or pelvic discomfort. In some cases, it may spread to nearby tissues or distant parts of the body, becoming more aggressive. The progression can be influenced by various factors, including genetics and lifestyle. Regular monitoring is important to assess the growth and spread of the cancer.