Active not recruitingPHASE3INTERVENTIONAL

Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency

This clinical trial is investigating a new treatment approach for men with prostate cancer that has spread to other parts of the body and is still sensitive to hormone therapy. Researchers are studying a drug called capivasertib, given alongside the usual treatment of abiraterone and hormone therapy (ADT). The trial specifically focuses on men whose cancer cells show a particular change called 'PTEN deficiency'. The main goal is to see if adding capivasertib can stop the cancer from growing or spreading for longer, and if it's safe. Half of the participants will receive capivasertib with their usual treatment, and the other half will receive a dummy pill (placebo) with their usual treatment, allowing doctors to compare the results fairly.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

1,012

Start

13 Jul 2020

Estimated completion

31 Mar 2027

Hormone-Sensitive Prostate Cancer

What is this study about?

This study is designed for men who have prostate cancer that has spread to other parts of their body (like bones or other organs) but is still responding to hormone treatments. This is called 'metastatic hormone-sensitive prostate cancer'. The researchers are trying to find out if adding a new drug, called capivasertib, to the treatments you might already be having – abiraterone and hormone therapy (ADT) – can work better than the standard treatment alone.

The main aim is to see if this new combination treatment can stop the cancer from getting worse or spreading for a longer time. They will also be looking closely at how safe the new drug is and what side effects people might experience. To decide if the treatment is working, doctors will compare how long it takes for the cancer to show signs of growing again on scans, or whether it causes death.

The study is particularly interested in men whose cancer cells have a specific genetic change, described as 'PTEN deficiency'. This means a particular gene called PTEN isn't working as it should. The researchers believe that capivasertib might be particularly effective for cancers with this specific characteristic.

Key takeaways

It tests a new drug (capivasertib) for metastatic hormone-sensitive prostate cancer.
Specifically for men whose cancer has a 'PTEN deficiency'.
Compares the new drug combo with standard treatment (abiraterone + ADT).
Aims to see if the new treatment can stop cancer growth for longer.
All participants are male, aged 18 or over.
You might receive the new drug or a dummy pill (placebo).

Who may be eligible?

This study is for men with prostate cancer that has recently been diagnosed as having spread (metastasized) but is still responding to hormone treatment. Your cancer should not have caused severe symptoms, or only mild ones. Important for this study, your cancer cells need to show a specific change called 'PTEN deficiency', which will be checked from a sample of your tumour.

You must be generally well enough to take part, able to swallow tablets, and your current hormone therapy (ADT) must have started within a specific recent timeframe. You shouldn't have had major surgery or radiation treatment for your prostate cancer recently, although some palliative radiation is allowed.

You'll need to be aged 18 or older to join this study. As it's a study for prostate cancer, all participants will be male.

Quick self-check

Is your prostate cancer still responding to hormone treatment?
Has your prostate cancer spread to other parts of your body?
Do you have a recent biopsy result showing 'PTEN deficiency'?
Are you able to swallow tablets?
Are you generally well and able to manage daily activities?
Have you started hormone therapy (ADT) recently (within the last 3 months)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will be given either the new drug, capivasertib, or a dummy pill (placebo), along with abiraterone and hormone therapy. You won't know which you are receiving, and neither will your doctor, which helps to make the study results fair.

Taking part will involve regular visits to the hospital for checks, blood tests, and scans to see how your body is responding to the treatment and how the cancer is behaving. You'll also need to fill in some questionnaires about your pain and tiredness levels. The total duration of your participation will depend on how you respond to the treatment, but follow-up will continue for a long time to monitor your health.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to a new treatment before it's widely available, which might be more effective for your cancer. However, there are also potential risks; new drugs can have side effects that are not yet fully known, or the treatment might not work for you. You will be closely monitored by a medical team to manage any side effects. Remember, joining a trial is always voluntary, and you have the right to withdraw at any time without affecting your future medical care.

Locations (323)

Research Site
Tucson, United States
Research Site
Tucson, United States
Research Site
La Jolla, United States
Research Site
Orange, United States
Research Site
San Diego, United States
Research Site
Denver, United States
Research Site
Lakewood, United States
Research Site
Norwich, United States
Research Site
Fort Myers, United States
Research Site
West Palm Beach, United States
Research Site
Chicago, United States
Research Site
Geneva, United States

+311 more sites — see the official record for the full list.

Common questions

What is PTEN deficiency?

PTEN deficiency means that a specific gene in your cancer cells isn't working properly. This study is looking at how a new drug might work for cancers with this particular change.

What is 'hormone-sensitive' prostate cancer?

This means your prostate cancer is still responding to treatments that lower male hormones (like testosterone) in your body. These hormones can make prostate cancer grow.

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

No, neither you nor your doctor will know if you're receiving capivasertib or the placebo. This is standard in trials to ensure results are accurate and unbiased.

What if my cancer doesn't have PTEN deficiency?

This study specifically requires your cancer to have PTEN deficiency. Unfortunately, if your cancer doesn't have this, you wouldn't be able to join this particular trial.

What are 'ADT' and 'abiraterone'?

ADT (Androgen Deprivation Therapy) is a common hormone treatment for prostate cancer. Abiraterone is another type of hormone therapy that stops the body from making male hormones, helping to slow cancer growth.