Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2, Randomized, Open-Label, Study of Lorigerlimab with Docetaxel or Docetaxel Alone in Participants with Metastatic Castration-Resistant Prostate Cancer

This research study is investigating a new treatment called Lorigerlimab for men with prostate cancer that has spread to other parts of the body and is no longer responding to hormone therapy. This type of cancer is known as metastatic castration-resistant prostate cancer. The study will compare Lorigerlimab given alongside docetaxel (a common chemotherapy drug) against docetaxel alone. Doctors want to see if adding Lorigerlimab helps slow down the cancer's growth or spread, measured by how long men live without their cancer getting worse on scans. They will also look at how many men respond to the treatment, how long those responses last, and overall survival. The study aims to find better ways to treat this serious condition.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Macrogenics Inc.

Enrolment target

Start

26 Sep 2023

Metastatic Castration-Resistant Prostate Cancer

What is this study about?

This study is called a Phase 2 trial. This means it's one of the earlier stages of testing a new drug, where doctors are trying to find out if it is safe and effective enough to move onto larger studies. The study is for men who have a type of prostate cancer that has spread to other parts of the body (metastatic) and is no longer being controlled by hormone treatments (castration-resistant). This is a serious condition, and finding new treatments is very important.

The main aim of this study is to see if adding a new drug called Lorigerlimab to standard chemotherapy (docetaxel) can help men live longer without their cancer growing or spreading further. They'll measure this by looking at scans to see if the cancer stays stable, shrinks, or gets worse. This is known as 'radiographic progression-free survival'.

Beyond that main goal, the researchers will also be looking at many other things. They want to know how many patients respond to the treatment, how long any improvements last, and the overall survival time. They'll also check how the treatment affects levels of a cancer marker called PSA in the blood, and if it helps with pain or improves the patient's quality of life. Understanding how the body handles the new drug and checking for any side effects are also key parts of this research.

Key takeaways

This study is for men with advanced prostate cancer not responding to hormone therapy.
It tests a new drug, Lorigerlimab, combined with standard chemotherapy (Docetaxel).
The main goal is to see if the new drug can stop cancer from getting worse for longer.
Researchers will also check for effects on pain, quality of life, and overall survival.
Participation involves regular hospital visits, tests, and questionnaires.

Who may be eligible?

To be able to take part in this study, you must be a man aged 18 years or older. There is no upper age limit, meaning older men can also be considered.

You would need to have been diagnosed with metastatic castration-resistant prostate cancer. This means your prostate cancer has spread beyond your prostate and is no longer responding to hormone treatments that lower testosterone.

There will be other detailed medical criteria that the study doctors will check to make sure the study is right for you and safe. This includes your general health, how well your organs are working, and what other treatments you've had. These checks are very important for your safety and to make sure the study results are accurate.

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 a man?
Are you 18 years old or older?
Have you been diagnosed with prostate cancer that has spread?
Is your prostate cancer no longer responding to hormone treatments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to one of two groups by chance (like flipping a coin). One group will receive the new drug Lorigerlimab along with the chemotherapy drug Docetaxel. The other group will receive Docetaxel alone. You won't get to choose which group you are in.

You will have regular hospital visits for treatments, blood tests, physical examinations, and scans to monitor your health and the cancer's progress. You will also be asked to fill out questionnaires about your pain and general well-being. These visits will be scheduled throughout the treatment period. The total duration of your participation will depend on how your cancer responds to the treatment and your overall health, and will involve follow-up appointments even after treatment stops to monitor your long-term health and survival.

Potential risks and benefits

Taking part in a clinical trial might offer potential benefits, such as access to a new treatment (Lorigerlimab) that isn't yet widely available, which could potentially slow down your cancer's progression or improve your quality of life. However, there are also potential risks; new drugs can have side effects that aren't fully known, and some side effects of the treatments (like chemotherapy) can be serious. Your doctors will carefully monitor you for any problems. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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

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Unverified
Spain
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Unverified
Poland
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Unverified
Belgium
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Unverified
Bulgaria
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Unverified
France

Common questions

What is 'metastatic castration-resistant prostate cancer'?

This is prostate cancer that has spread to other parts of the body (metastatic) and is no longer responding to hormone-blocking treatments (castration-resistant).

What is Lorigerlimab?

Lorigerlimab is a new drug being tested. It's not yet approved for general use, and this study aims to see how well it works and if it's safe.

What is Docetaxel?

Docetaxel is a standard chemotherapy drug commonly used to treat prostate cancer that has spread.

What does 'radiographic progression-free survival' mean?

This refers to the length of time you live without your cancer growing or spreading further, as seen on medical scans like X-rays or MRI.

Will I know if I'm getting the new drug?

No, this is an 'open-label' study, but it is randomized. This means you will know whether your treatment includes Lorigerlimab or is docetaxel alone, but which group you are in will be decided by chance.