Active not recruitingPHASE3INTERVENTIONAL

Study of Capivasertib + Docetaxel vs Placebo + Docetaxel as Treatment for Metastatic Castration Resistant Prostate Cancer (mCRPC)

This research study is for men with advanced prostate cancer that has spread to other parts of the body (metastatic) and is no longer responding to hormone therapy (castration-resistant). We are investigating whether a new drug called capivasertib, when given alongside standard chemotherapy (docetaxel), is more effective than docetaxel alone. The main goal is to see if taking capivasertib in combination with docetaxel can help patients live longer or keep their cancer from growing for a longer period of time. All participants will also receive steroids and continue their hormone-blocking treatment. This is a Phase 3 study, meaning it’s a large-scale trial to confirm the benefits and safety of the new treatment compared to existing options.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

1,035

Start

25 Mar 2022

Estimated completion

04 Mar 2026

Prostate Cancer

What is this study about?

Prostate cancer is a common cancer that affects men. Sometimes, even after treatment, the cancer can spread to other parts of the body, which is called metastatic prostate cancer. When the cancer stops responding to hormone therapy, it's called castration-resistant. At this stage, doctors look for new ways to keep the cancer in check and improve patients' quality of life.

This study aims to find out if a new drug, capivasertib, can improve treatment for men with this advanced form of prostate cancer. Capivasertib is being tested alongside a standard chemotherapy drug called docetaxel. Chemotherapy is a medicine that helps to kill cancer cells throughout the body. The study will compare patients who receive capivasertib plus docetaxel with patients who receive a 'dummy' drug (placebo) plus docetaxel. Both groups will also receive steroid treatment and continue their existing hormone therapy.

The main purpose of this research is to see if the combination of capivasertib and docetaxel can help men live longer or keep the cancer from growing for a greater length of time than docetaxel alone. Finding more effective treatments is crucial for managing advanced prostate cancer and improving outcomes for patients.

Key takeaways

Tests a new drug (capivasertib) for advanced prostate cancer.
Compares capivasertib + chemotherapy vs. placebo + chemotherapy.
Aims to improve survival and stop cancer growth.
For men with metastatic, castration-resistant prostate cancer.
Participation involves regular clinic visits and monitoring.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for men, aged 18 and older, with prostate cancer that has spread to other parts of the body (metastatic) and is no longer responding to standard hormone treatments. You must have already tried a newer type of hormone therapy (like abiraterone or enzalutamide) for at least three months, and your cancer must have shown signs of getting worse while on it. Your doctors should also think you are generally well enough to receive docetaxel chemotherapy.

Critically, you need to have a tissue sample from your prostate cancer available for testing. Your testosterone levels must be low, and you need to be continuing with your existing hormone-blocking treatment. You should also be able to take medication by mouth.

There are certain reasons you might not be able to join. For example, if you've had major surgery or widespread radiation recently, or if you have specific heart problems, brain tumours, or uncontrolled spinal cord compression. The research team will carefully check all these details with you to make sure it's safe and appropriate for you to participate.

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 aged 18 or older?
Do you have prostate cancer that has spread?
Has your cancer stopped responding to hormone therapy?
Have you previously taken drugs like abiraterone or enzalutamide?
Are you generally well enough for chemotherapy?
Do you have a prostate cancer tissue sample available?

Answer every question to see your result.

What does participation involve?

If you are eligible and choose to take part, you will be randomly assigned to one of two groups: one receiving capivasertib plus docetaxel, and the other receiving a placebo (dummy pill) plus docetaxel. You won't know which group you are in. Both groups will also receive steroids and continue with their hormone therapy.

Taking part will involve regular visits to the clinic for treatments, blood tests, physical examinations, and scans (like bone scans or CT scans) to monitor your health and how your cancer is responding. You'll take the study medication (either capivasertib or placebo) as directed, along with your docetaxel chemotherapy. The frequency of visits and assessments will be explained in detail by the study team, and you will have follow-up appointments after your treatment period. The total duration of your participation will depend on how you respond to the treatment and your health, but you'll be monitored throughout the study.

Potential risks and benefits

Participating in a clinical trial offers the potential benefit of accessing a new treatment that isn't yet widely available, which might be more effective than current options for your condition. However, there's no guarantee it will work for you, and there might be side effects from the investigational drug, some of which could be serious or unexpected. Taking part also carries the general risks associated with medical procedures, like blood tests or scans. It's important to remember that you have the absolute right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (217)

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

Research Site
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Yuma, United States
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Beverly Hills, United States
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Cerritos, United States
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Fresno, United States
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Los Angeles, United States
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Sacramento, United States
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San Francisco, United States
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Santa Barbara, United States
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Santa Monica, United States
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Santa Rosa, United States
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Aurora, United States
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Lakewood, United States

Common questions

What is 'metastatic castration-resistant prostate cancer'?

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

What is a 'placebo'?

A placebo is an inactive pill that looks just like the study drug but contains no medicine. It helps researchers compare the real drug's effects accurately.

Will I still get my standard chemotherapy?

Yes, all participants in this study will receive docetaxel chemotherapy, along with steroid therapy, regardless of whether they get the new drug or the placebo.

Why is a tissue sample needed?

Researchers may use your archived tissue sample to learn more about the biology of your cancer, which could help them understand how the new drug works.

Can women participate in this study?

No, this specific study is only open to men because it focuses on prostate cancer, which exclusively affects men.