Active not recruitingPHASE3INTERVENTIONAL

Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC

This important study is for men with advanced prostate cancer that has spread to other parts of the body and is no longer helped by initial hormone treatment (metastatic castration-resistant prostate cancer, or mCRPC). The research team wants to find out if a new combination of two drugs, cabozantinib and atezolizumab, is more effective and safer than current standard hormone therapies, like abiraterone or enzalutamide. Participants will receive either the new drug combination or one of the standard hormone treatments. The study aims to see if the new combination can slow down the cancer's growth or help people live longer. This is a Phase 3 study, meaning it's one of the final steps before a new treatment might become widely available.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Exelixis

Enrolment target

575

Start

19 Oct 2020

Estimated completion

16 Oct 2026

Metastatic Prostate Cancer Prostate Adenocarcinoma

What is this study about?

This study is investigating a new treatment approach for men with a type of advanced prostate cancer called metastatic castration-resistant prostate cancer (mCRPC). This means the cancer has spread beyond the prostate and is no longer being controlled by standard hormone-blocking treatments. When prostate cancer spreads, it often goes to the bones or other organs. Finding effective ways to manage this can be very challenging.

Researchers want to see if combining two drugs, cabozantinib and atezolizumab, works better than other hormone treatments already in use. You might have heard of these other treatments like abiraterone or enzalutamide. The study is particularly looking for men who have tried one of these hormone treatments before, but their cancer is now progressing. The goal is to compare the new combination against these established treatments to see if it can slow the cancer's growth or improve how long people live.

This is a 'Phase 3' study, which means it's a large, carefully designed trial. It's normally the last step before a new treatment can be approved and made available to more patients. The study aims to gather important information about how safe and effective this new combination is for men with this specific type of prostate cancer.

Key takeaways

This study is for men with advanced prostate cancer that has spread and is no longer responding to initial hormone therapy.
It compares a new drug combination (cabozantinib and atezolizumab) with standard hormone treatments.
The main goals are to see if the new combination can slow cancer growth or help people live longer.
Participation involves taking study medications, regular check-ups, and scans.
It's a Phase 3 study, meaning it's a critical step in assessing a potential new treatment.

Who may be eligible?

To be considered for this study, you must be a man aged 18 or older with prostate cancer that has spread. A doctor must have confirmed your prostate cancer through a biopsy (tissue sample).

You must have already received one, and only one, hormone treatment for your prostate cancer, and your cancer must now be growing again despite this treatment. This means your cancer is "castration-resistant." You also need to have areas of cancer that can be measured outside of your pelvis, for example, in your liver or lungs, or in lymph nodes high in your abdomen.

There are also some things that would prevent you from joining. For example, if you've already had other types of non-hormonal treatment for your advanced prostate cancer, or if you've received certain medications too recently. Your overall health and organ function will also be carefully checked, and you should be able to move around normally and do most daily activities without significant difficulty.

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?
Has a doctor confirmed you have prostate cancer that has spread?
Have you had one, and only one, hormone treatment for your prostate cancer, and it's now growing again?
Do you have areas of cancer that can be measured outside your pelvis (e.g., in organs or lymph nodes high in your belly)?
Are you generally well enough to do most of your daily activities without much trouble?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be randomly assigned to one of two groups, like flipping a coin. One group will receive the new combination treatment (cabozantinib and atezolizumab), and the other group will receive one of the standard hormone treatments (abiraterone or enzalutamide) along with prednisone. You won't know which treatment you are receiving, but your doctor will.

You will have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your cancer and your general health. You will take the study medication as prescribed. The study will continue for as long as the treatment is helping you, or until you experience side effects that make it necessary to stop, or if you choose to withdraw. Regular follow-up will continue even after you stop taking the study drugs, to track your health and cancer progression.

Potential risks and benefits

Participating in this study might offer potential benefits, such as access to a new treatment option that is not yet widely available, and close monitoring by a specialist medical team. However, there are also potential risks involved. The study drugs can cause side effects, which may vary from mild to severe, and could include things like fatigue, tummy upsets, or changes in blood tests. The new treatment might not work for everyone, or it might not work better than existing treatments. You can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (280)

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

Exelixis Clinical Site #4
Verified postcode
Tucson, United States
Exelixis Clinical Site #42
Verified postcode
Duarte, United States
Exelixis Clinical Site #2
Verified postcode
Fullerton, United States
Exelixis Clinical Site #224
Verified postcode
La Jolla, United States
Exelixis Clinical Site #3
Verified postcode
Marina del Rey, United States
Exelixis Clinical Site #114
Verified postcode
San Diego, United States
Exelixis Clinical Site #125
Verified postcode
Santa Monica, United States
Exelixis Clinical Site #245
Verified postcode
Stanford, United States
Exelixis Clinical Site #91
Verified postcode
Aurora, United States
Exelixis Clinical Site #14
Verified postcode
Denver, United States
Yale University School of Medicine
Verified postcode
New Haven, United States
Yale University, School of Medicine
Verified postcode
New Haven, United States

Common questions

What is 'metastatic castration-resistant prostate cancer'?

This means your prostate cancer has spread to other parts of your body (metastatic) and is continuing to grow even though you are receiving hormone-blocking treatment (castration-resistant).

What are cabozantinib and atezolizumab?

These are two different drugs being tested together. Cabozantinib aims to block signals that help cancer cells grow and blood vessels that feed the tumour. Atezolizumab is an immunotherapy that helps your body's immune system fight the cancer.

Will I know which treatment I am getting?

No, this is a 'blinded' study for participants, meaning you will not know whether you are receiving the new combination or the standard treatment. This helps ensure fair results.

What does 'Phase 3' study mean?

A Phase 3 study is one of the final stages of clinical research. It involves a larger number of patients and aims to confirm if a new treatment is effective and safe compared to existing treatments, before it can be potentially approved for wider use.

Can I stop participating if I want to?

Yes, absolutely. You have the right to withdraw from the study at any time, for any reason, and it will not affect the quality of your usual medical care.