AuthorisedTherapeutic exploratory (Phase II)Interventional

A Phase 2, Open-Label, Single-Arm, Multicentre Study Investigating the Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of Teverelix DP, a Gonadotropin-releasing Hormone (GnRH) Antagonist, in Participants with Advanced Prostate Cancer

This study is testing a new drug called Teverelix in men who have advanced prostate cancer. The main goal is to find out if this drug can effectively lower the levels of testosterone in the body. Testosterone is a hormone that can unfortunately make prostate cancer grow more quickly. Researchers will be looking closely at how well Teverelix works to keep testosterone low over time, as well as if it causes any unwanted side effects. By understanding how Teverelix affects the body (pharmacokinetics and pharmacodynamics) and its overall safety, the study aims to see if it could be a helpful treatment option for men with this condition.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Antev Limited, Antev Nordic AB

Enrolment target

Start

19 Apr 2024

Advanced prostate cancer

What is this study about?

This research study is about finding new and better ways to treat advanced prostate cancer. Prostate cancer often relies on male hormones, particularly testosterone, to grow. One common way to treat this cancer is to lower these hormone levels, a process called 'castration' in a medical sense, even though it doesn't involve surgery.

In this study, doctors are looking at a new drug called Teverelix. This drug works by blocking signals that tell your body to produce testosterone. We want to see how well Teverelix keeps testosterone levels very low, which hopefully slows down or stops the cancer from growing. We will also be carefully monitoring how the drug affects your body and if there are any side effects.

This is a 'Phase 2' study, meaning it's an earlier stage of testing a new drug. The aim is to gather important information about Teverelix, such as the best dose and how safe and effective it is, before it can be considered for wider use. Participating in such a study helps doctors learn more about cancer and develop new treatments for the future.

Key takeaways

Tests a new drug called Teverelix for advanced prostate cancer.
Aims to lower testosterone levels, which fuels cancer growth.
Investigates the drug's effectiveness and safety.
It's a Phase 2 study looking for early results.
Involves regular clinic visits and blood tests over several months.

Who may be eligible?

To be part of this study, you must be an adult male, at least 18 years old. There's no upper age limit, so older men can also take part.

Because this study is specifically for advanced prostate cancer, you would need to have received a diagnosis of this condition from your doctor. The medical team will check details about your specific health, including other medical conditions you might have and any other medications you are currently taking.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult male, aged 18 or older?
Have you been diagnosed with advanced prostate cancer?
Are you generally able to attend regular clinic appointments?
Have you discussed your current health conditions and medications with your doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study drug, Teverelix, directly from the study team. You would have regular visits to the clinic for medical check-ups, blood tests, and to discuss any side effects you might be experiencing. These tests help the doctors understand how the drug is working in your body and how it's affecting your testosterone levels.

The study would involve a commitment over several months. For example, the initial key period where doctors closely monitor your testosterone levels is from Day 29 to Day 155 of treatment. You would be given a detailed schedule of appointments and what to expect at each one. There would also be follow-up appointments after you finish taking the study drug to ensure your health is still being monitored.

Potential risks and benefits

Taking part in a clinical trial might offer potential benefits, such as access to a new treatment before it's widely available, and you'll receive close medical attention. However, there are also potential risks; the study drug might cause side effects, some of which could be serious or unexpected. It's important to understand that new drugs don't always work, and there's no guarantee the treatment will help your specific condition. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Lithuania

Common questions

What does 'advanced prostate cancer' mean?

It means the cancer has grown outside the prostate gland and may have spread to other parts of the body.

What is testosterone and why is it important for prostate cancer?

Testosterone is a male hormone that can make prostate cancer cells grow faster. Lowering it can help slow down the cancer.

What is Teverelix and how does it work?

Teverelix is a new drug being tested. It works by stopping your body from making as much testosterone.

Will I know if I'm getting the drug or a dummy pill?

This is an 'open-label' study, which means everyone who takes part will receive the study drug, Teverelix.

How long will I need to be in the study?

The main part of the study involves treatment and monitoring over several months, with careful checks of your testosterone levels for at least 155 days.