Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

“A randomized phase II trial to evaluate the antitumor activity of Enzalutamide and Talazoparib (PF-06944076) for the treatment of metastatic hormone-naïve prostate cancer”

This research study is looking at new ways to treat prostate cancer that has spread to other parts of the body and hasn't been treated with hormone therapy yet. It's a 'Phase II' study, which means it's testing if these treatments are safe and show promise before larger studies are done. The study is comparing two medicines, Talzenna and Xtandi, which are already approved for other uses. Researchers want to see if these drugs, either alone or together, can reduce the amount of prostate-specific antigen (PSA) in the blood to very low levels. They will also check if the drugs stop the cancer from growing and help patients live longer and feel better. This is an important step to find better treatments for this type of prostate cancer.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Medica Scientia Innovation Research S.L.

Enrolment target

Start

20 Aug 2024

Metastatic hormone–naïve prostate cancer (mHNPC)

What is this study about?

This study is a medical research project focused on prostate cancer that has spread to other parts of the body and hasn't yet been treated with hormone therapy. This type of cancer is often called metastatic hormone-naïve prostate cancer, or mHNPC.

The main goal of this study is to see how well two different medications, Enzalutamide (known as Xtandi) and Talazoparib (known as Talzenna), work in treating this cancer. Xtandi is already used to treat prostate cancer, and Talzenna is used for other cancers. Researchers want to find out if using these drugs can significantly lower a blood marker called PSA (prostate-specific antigen) in patients. A very low PSA level can suggest that the treatment is working well.

By carefully looking at PSA levels, scans, and how patients feel, doctors hope to understand if these treatments can shrink the cancer, stop it from growing, and ultimately help people live longer and improve their quality of life. This kind of study helps us learn more about potential new ways to fight prostate cancer.

Key takeaways

This study investigates new treatments for advanced prostate cancer that hasn't had hormone therapy.
It tests two existing drugs, Talzenna and Xtandi, to see their effectiveness.
The main goal is to reduce PSA levels and stop the cancer from growing.
Participation involves regular clinic visits, blood tests, and scans.
The study aims to find better ways to treat this specific type of prostate cancer.

Who may be eligible?

To be considered for this study, you must be a man aged 18 years or older. You will need to have a specific type of prostate cancer that has spread to other parts of your body. Also, you must not have had any hormone therapy for your prostate cancer before joining this study.

The research team will carry out several checks to make sure you fit all the necessary criteria for the study. This is important to ensure the study is safe for you and that the results are clear and reliable. They will review your medical history and conduct tests to confirm you meet all the health requirements.

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 male and 18 years old or older?
Do you have prostate cancer that has spread to other parts of your body?
Have you NOT received hormone therapy for your prostate cancer yet?
Are you generally well enough to take part in a clinical study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either Talzenna capsules, Xtandi tablets, or a combination. The type and amount of medication you receive will be decided randomly, much like flipping a coin. You will have regular visits to the clinic for medical check-ups, blood tests (including PSA), and scans to see how the treatment is working and to monitor your health. These visits will be more frequent at the beginning and then become less frequent over time.

The main part of the study will last for a certain period, likely twelve months, to see how the treatments affect your PSA levels. However, you will continue to be monitored for a longer time, even after you stop taking the study medication, to see how you are doing in the long term. This follow-up is important to understand the full effects of the treatment, including any side effects. The total duration of your involvement could be several years, depending on how long your doctors need to follow your health.

Potential risks and benefits

Taking part in this study might offer potential benefits, such as receiving a novel combination of established drugs for your prostate cancer, which could help slow its progression. However, there's no guarantee that the treatment will work for everyone, and it might not be better than standard treatments. There are also potential risks involved, mainly from side effects of the drugs, which the study team will carefully monitor. You will be told about all known side effects before you decide to join. Remember, taking part in a clinical trial is always voluntary, and you have the right to withdraw at any time without 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
Spain

Common questions

What does 'metastatic hormone-naïve prostate cancer' mean?

This means your prostate cancer has spread to other parts of your body, and you haven't received hormone therapy for it yet.

What are PSA levels, and why are they important in this study?

PSA is a protein made by prostate cells. High PSA levels can suggest prostate cancer. In this study, very low PSA levels are a sign that the treatment might be working well.

What is a 'Phase II' study?

A Phase II study is a stage of clinical trial that checks if a new treatment is safe and shows promise before it's tested on a larger group of people in Phase III studies.

Will I know which treatment I'm receiving?

In some studies, participants or even the doctors don't know which specific treatment is being given (this is called 'blinding') to keep the results fair. The study team will explain how this works.

What happens after the study ends?

Even after you stop taking the study medication, the doctors will continue to follow your health for some time. This helps them understand the long-term effects of the treatments you received.