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Study on Teverelix for Patients with Advanced Prostate Cancer

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
Vilniaus universiteto ligonine Santaros klinikos VšĮ Vilnius Lithuania
Klaipedos universiteto ligonine VšĮ Klaipeda Lithuania
Vilnius University Hospital Vilnius Lithuania

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Lithuania Lithuania
Not yet recruiting
18.07.2026

Trial locations

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.

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.

Trial ID:
2023-509255-14-01
Trial Phase:
Therapeutic exploratory (Phase II)

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