Recruiting

Study on How Degarelix and Drug Combination Affect Gut Health in Patients with Prostate Cancer or Benign Prostate Hyperplasia

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 clinical trial is focused on studying the effects of medications used to treat prostate cancer and benign prostate hyperplasia, which is a non-cancerous enlargement of the prostate gland. The study will involve medications such as FIRMAGON (containing the active substance degarelix), Duodart (containing tamsulosin hydrochloride and dutasteride), and FINASTERIDE. These medications are used to manage symptoms and progression of prostate conditions. The purpose of the study is to understand how these prostate medications interact with the gut microbiota, which is the community of microorganisms living in the intestines.

Participants in the study will receive one of the medications mentioned above. FIRMAGON is administered as an injection under the skin, while Duodart and FINASTERIDE are taken orally in capsule or tablet form. The study will last for a period of up to six months, during which the effects of the medications on the gut microbiota will be observed. The gut microbiota plays a crucial role in digestion and overall health, and this study aims to see how it is affected by prostate treatments.

Throughout the study, changes in the gut microbiota will be monitored, along with other factors such as prostate-specific antigen (PSA) levels and prostate volume. PSA is a protein produced by the prostate gland, and its levels can indicate changes in prostate health. By understanding these interactions, the study hopes to provide insights into how prostate treatments can influence gut health and metabolism. Participants will be closely monitored to ensure their safety and well-being during the trial.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit and consent
Upon joining the study, you will have an initial visit where the study procedures will be explained in detail. You will be asked to provide a signed and dated informed consent form, confirming your willingness to participate and comply with all study procedures.
During this visit, your eligibility will be confirmed based on your medical history, including a diagnosis of prostate cancer or benign prostate hyperplasia.
Step 2
Medication administration
You will begin taking the study medications. The medications include FIRMAGON (degarelix) administered as a subcutaneous injection, and oral medications such as Duodart (tamsulosin hydrochloride, dutasteride), FINASTERIDE, and DUTASTERIDE.
The dosage and frequency of these medications will be determined by the study protocol and your healthcare provider. The treatment will continue for a specified duration, typically up to six months, with regular monitoring.
Step 3
Regular follow-up visits
You will have regular follow-up visits to monitor your health and the effects of the medication. These visits will include assessments of your prostate health, such as measuring prostate volume and PSA levels (a marker used to evaluate prostate health).
The study aims to observe changes in your gut microbiota composition and metabolism over a period of two months, as well as the response of your prostate to the medication over two and six months.
Step 4
End of study procedures
At the end of the study period, you will undergo final assessments to evaluate the overall impact of the treatment on your prostate health and gut microbiota.
You will be informed about the results of the study and any relevant findings related to your health.

Who can join the trial?

4 criteria

Must have a histologically confirmed diagnosis of prostate cancer or benign prostate hyperplasia. Histologically confirmed means that the diagnosis has been confirmed by examining tissue under a microscope.
Must provide a signed and dated informed consent form. This means you agree to participate in the study after being informed about all aspects of the trial.
Must have the ability and willingness to follow all study procedures and be available for the entire duration of the study.
Must be male and older than 18 years.

Who cannot join the trial?

4 criteria

Patients who are not male cannot participate.
Patients who are under 18 years old or over 65 years old cannot participate.
Patients with medical conditions other than prostate cancer or benign prostate hyperplasia cannot participate.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or people who cannot make decisions for themselves.

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Verified sites

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Turku University Hospital
Turku, Finland

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Investigated drugs

5-ARI
stands for 5-alpha-reductase inhibitors. These medications are used to treat conditions like an enlarged prostate. They work by blocking the action of an enzyme called 5-alpha-reductase, which is involved in the production of a hormone that can cause the prostate to grow. By reducing the levels of this hormone, 5-ARI medications can help shrink the prostate and relieve symptoms such as difficulty urinating.
ADT
stands for androgen deprivation therapy. This therapy is used to treat prostate cancer by reducing the levels of male hormones, called androgens, in the body. Androgens can promote the growth of prostate cancer cells, so lowering their levels can help slow down or stop the growth of the cancer. ADT can be achieved through medications that lower hormone levels or through surgical procedures that remove hormone-producing organs.

What is already known about the treatment

5-Alpha Reductase Inhibitors (5-ARI)
This medication is typically taken orally and is used to treat conditions like prostate cancer and benign prostate hyperplasia. It works by blocking the enzyme 5-alpha reductase, which is involved in the conversion of testosterone to dihydrotestosterone (DHT), a hormone that can cause prostate growth. By reducing DHT levels, 5-ARI helps to shrink the prostate and alleviate symptoms. It is well-documented in medical literature and is a common treatment option for these conditions.
Androgen Deprivation Therapy (ADT)
This treatment is often administered through injections or oral medications and is used primarily for prostate cancer. ADT works by reducing the levels of androgens, such as testosterone, which can fuel the growth of prostate cancer cells. By lowering these hormone levels, ADT helps to slow down or stop the progression of the cancer. It is a well-established therapy in the medical field and is frequently discussed in clinical studies and literature.

Investigated diseases

Prostate Cancer
Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. It often begins with small changes in the size and shape of prostate cells, which can develop into a tumor. The disease may progress slowly and remain confined to the prostate gland, where it may not cause serious harm. However, in some cases, it can grow more quickly and spread to nearby tissues or other parts of the body. The progression of prostate cancer can vary greatly among individuals, with some experiencing rapid changes and others having a more indolent course. The growth and spread of cancer cells can lead to various symptoms, including difficulty urinating and pelvic discomfort.
Benign Prostatic Hyperplasia
Benign prostatic hyperplasia (BPH) is a condition characterized by an enlarged prostate gland. This enlargement is not cancerous and is common as men age. The growth of the prostate can press against the urethra, leading to urinary symptoms such as increased frequency, urgency, and difficulty starting urination. BPH progresses gradually, and the severity of symptoms can vary widely among individuals. Over time, the enlargement may lead to bladder, urinary tract, or kidney problems if left unmanaged. The condition is primarily related to hormonal changes and the natural aging process.