AuthorisedTherapeutic confirmatory (Phase III)Interventional

One multicenter, randomized, open, phase III clinical study on SHR3680 combined with androgen deprived therapy (ADT) versus Bicalutamide combined with ADT in treatment of metastatic hormone-sensitive prostate cancer with high tumor load.

This research study is for men with prostate cancer that has spread to other parts of the body (metastatic) and is still sensitive to hormone treatment. Doctors are comparing a new drug called SHR3680, given alongside standard hormone therapy, with an existing treatment called Bicalutamide, also given with standard hormone therapy. The main goal is to find out if the new treatment keeps the cancer from getting worse for longer and helps people live longer. They will also look at how safe the treatments are, how they affect things like pain related to bones, and how long it takes before a different cancer treatment is needed. This is a Phase 3 study, meaning it's a key step in testing if new treatments are better than existing ones.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Jiangsu Hengrui Pharmaceuticals Co. Ltd.

Enrolment target

Start

26 Nov 2024

Metastatic hormone-sensitive prostate cancer with high tumor load

What is this study about?

This research study is about finding better ways to treat prostate cancer that has spread from its original site and is still affected by hormones in the body. When prostate cancer spreads, it's called 'metastatic.' If it's 'hormone-sensitive,' it means that treatments that lower male hormones (like testosterone) can help control it. This study is for men whose cancer has spread and has a 'high tumour load,' which means there's a significant amount of cancer present.

Researchers want to see if a new drug, SHR3680, combined with standard hormone therapy, works better than a common treatment called Bicalutamide, also given with standard hormone therapy. Hormone therapy often involves injections that reduce the body's testosterone levels, like Zoladex. Bicalutamide (also known as Casodex) is another type of hormone treatment taken as a tablet.

The main aim of this study is to compare how long men taking each combination of treatments live, and how long the cancer is kept under control without getting worse. They will also look at other important things, like how the treatments affect pain, how safe they are, and if they delay the need for further cancer treatments. This is a Phase 3 study, which means it’s a big, important step in testing new treatments to see if they are better than what’s currently available.

Key takeaways

This study compares a new drug (SHR3680) with a standard treatment (Bicalutamide) for advanced prostate cancer.
It's for men with prostate cancer that has spread and is still sensitive to hormone treatment.
Both treatments will be given alongside standard hormone therapy.
The main goals are to see which treatment prolongs life and keeps the cancer under control for longer.
This is a Phase 3 study, meaning it's an important step in finding better treatments.
You would be closely monitored for cancer changes and side effects.

Who may be eligible?

This study is specifically for men who have been diagnosed with prostate cancer that has spread to other parts of their body. Your doctors will also need to confirm that your cancer is 'hormone-sensitive,' meaning it responds to treatments that lower male hormones, and that it has a 'high tumour load,' indicating a significant amount of cancer has spread.

You must be 18 years old or older to take part in this study. There is no upper age limit mentioned, so older men may also be eligible if they meet all other criteria. The study is only for biological males, as prostate cancer typically affects men.

Before joining, you would have checks to make sure your overall health allows you to safely participate in the study. Your medical team will review all your health information to confirm if this study might be a suitable option for you.

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 who has been diagnosed with prostate cancer?
Has your prostate cancer spread to other parts of your body?
Is your cancer sensitive to hormone treatments?
Are you 18 years old or older?
Do you have a 'high tumour load' (your doctor will confirm this based on scans and tests)?
Are you well enough to participate 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 would be randomly assigned to one of two treatment groups – like flipping a coin, but done by a computer. You would either receive the new drug SHR3680 plus standard hormone therapy, or Bicalutamide plus standard hormone therapy. Both groups would also receive regular injections (like Zoladex) to lower male hormones.

You would have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your cancer and your general health. These visits will help the study doctors see how you are responding to the treatment and if there are any side effects. You would receive your study medications during these visits or be given instructions on how to take them at home.

The total duration of your participation would involve taking the medication for as long as it is working and is safe for you, followed by regular follow-up appointments to track your health even after you stop taking the study drugs. The exact number of visits and their timing would be clearly explained by the study team.

Potential risks and benefits

Taking part in a research study has potential benefits and potential risks. You might benefit from receiving a new treatment that could be more effective than existing options, or your cancer might be controlled for longer. However, there's no guarantee that the treatment will work for you, or that it will be better than standard care. All medications can have side effects, and the study treatments may cause side effects that are currently unknown or more severe than expected. The study team will monitor you closely for any issues. It's very important to remember that participating in a clinical trial is always voluntary. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care. Before deciding, the study doctor will explain all known potential benefits and risks in detail, and you'll have plenty of opportunity to ask questions.

Locations (3)

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

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Unverified
Czechia
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Unverified
Bulgaria
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Unverified
Poland

Common questions

What is 'metastatic hormone-sensitive prostate cancer'?

This is prostate cancer that has spread from the prostate gland to other parts of the body (metastatic), and it still responds to treatments that lower male hormones (hormone-sensitive).

What are SHR3680 and Bicalutamide?

SHR3680 is a new treatment being tested. Bicalutamide is an existing, commonly used treatment for prostate cancer. Both are types of hormone therapy.

What does a 'Phase 3' study mean?

Phase 3 is a major step in testing a new drug. It means the treatment has already shown promise in earlier studies, and now it's being compared with existing treatments in a larger group of people to confirm its effectiveness and safety.

What is 'standard hormone therapy'?

This usually refers to injections (like Zoladex) that reduce the amount of male hormones in your body, which helps to slow down the growth of prostate cancer.

Will I know which treatment I'm receiving?

This is an 'open-label' study, which means both you and your study doctor will know which treatment you are receiving (either SHR3680 or Bicalutamide, both combined with standard hormone therapy).