Not yet recruiting

Study on Teverelix for Patients with Advanced Prostate Cancer

Verified siteInvestigationalNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying advanced prostate cancer, a condition where cancer cells form in the tissues of the prostate and may spread to other parts of the body. The treatment being investigated is called Teverelix DP, which is a type of medication known as a gonadotropin-releasing hormone (GnRH) antagonist. This medication is designed to help manage hormone levels in the body, which can be important in treating prostate cancer.

The purpose of this study is to evaluate how effective Teverelix DP is in reducing testosterone levels in patients with advanced prostate cancer. The study will monitor participants to see if the medication can lower testosterone to a specific level by Day 29 and maintain this level until Day 155. This is important because reducing testosterone can help slow the growth of prostate cancer.

Participants in the study will receive Teverelix DP as a solution for injection. The study will be conducted over several months, and participants will be closely monitored to assess the safety and effectiveness of the treatment. The study aims to provide valuable information on how well Teverelix DP works in managing advanced prostate cancer and its potential benefits for patients.

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
Participation begins after meeting specific criteria: being male, aged 18 years or older, with advanced prostate cancer suitable for hormone therapy, and not previously treated with GnRH analogues.
Step 2
Initial treatment
The treatment involves the administration of teverelix DP, a medication given as a solution for injection. This is done through a method called parenteral administration, which means the medication is injected directly into the body.
Step 3
Treatment schedule
The goal is to achieve a reduction in testosterone levels to below 0.5 ng/mL by Day 29 and maintain this level until Day 155. This is referred to as the castration rate.
Step 4
Monitoring and evaluation
Throughout the study, testosterone levels are regularly monitored to ensure they remain below the target level. The primary focus is on maintaining these levels from Day 29 to Day 155.
Step 5
Study completion
The study is expected to conclude by October 31, 2026. The effectiveness of the treatment is evaluated based on the ability to sustain the target testosterone levels throughout the study period.

Who can join the trial?

5 criteria

The patient must be a male.
The patient must be aged 18 to 85 years at the start of the treatment period.
The patient must have a confirmed diagnosis of advanced prostate cancer. This means the cancer is either spreading to other parts of the body (metastatic) or not spreading (non-metastatic), and it is sensitive to hormone treatment but cannot be cured.
The patient must be suitable for androgen deprivation therapy, which is a treatment to lower male hormones that can help the cancer grow.
The patient must not have received treatment with GnRH analogues before. These are medications used to lower testosterone levels.

Who cannot join the trial?

3 criteria

Patients who do not have advanced prostate cancer cannot participate.
Females cannot participate, as the study is only for males.
Individuals who are considered part of a vulnerable population cannot participate. This means people who might need extra protection or care, like those who cannot make decisions for themselves.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Viesosios istaigos Vilniaus universiteto ligonines Santaros kliniku filialas Nacionalinis vezio centras
Responsive
Vilnius, Lithuania
Vilniaus universiteto ligonine Santaros klinikos VšĮ
Responsive
Vilnius, Lithuania

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Teverelix DP is a medication being studied for its effects on advanced prostate cancer. It works as a gonadotropin-releasing hormone (GnRH) antagonist. The goal of using Teverelix DP in this trial is to lower testosterone levels in the body, which can help manage prostate cancer. The study aims to see if Teverelix DP can effectively reduce testosterone to a very low level by Day 29 and maintain this low level until Day 155.

Teverelix

What is already known about the treatment

Teverelix DP – This medication is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating advanced prostate cancer. It is a gonadotropin-releasing hormone (GnRH) antagonist, which works by blocking the action of GnRH, leading to a decrease in testosterone levels. This reduction in testosterone is crucial for managing prostate cancer, as the hormone can promote cancer growth. Teverelix DP is being evaluated for its ability to maintain low testosterone levels over a specified period, which is important for controlling the progression of the disease.

Investigated diseases

Advanced Prostate Cancer – This is a stage of prostate cancer where the disease has spread beyond the prostate gland to other parts of the body. It often progresses slowly, but in advanced stages, it can spread to bones, lymph nodes, and other organs. Symptoms may include difficulty urinating, pain in the back or hips, and fatigue. The progression of the disease can lead to more severe symptoms as it affects more areas of the body. Hormonal changes, such as increased testosterone levels, can influence the growth and spread of cancer cells. Management of the disease focuses on controlling symptoms and slowing progression.