RecruitingPHASE3INTERVENTIONAL

AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)

This research study, called VECTRA-01, is looking into a new treatment called AZD2265 for men who have prostate cancer that has spread to other parts of the body and is resistant to hormone therapy. We're comparing AZD2265 to existing standard treatments like specific chemotherapy or hormone-blocking drugs. The main goal is to find out if AZD2265 can be more effective at stopping the cancer from growing (checked by scans) and helping men live longer. Around 670 men will take part, receiving either the new drug or a standard treatment. They'll be monitored closely with scans and for any side effects throughout the study, which will help us understand if this new treatment is a better option.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

670

Start

04 May 2026

Estimated completion

20 Dec 2029

Metastatic Castration-resistant Prostate Cancer

What is this study about?

This study, known as VECTRA-01, is designed to investigate a new medication called AZD2265 for a specific type of prostate cancer. This is for men whose prostate cancer has spread to other parts of the body (metastatic) and is no longer responding to standard hormone treatments (castration-resistant). We understand that facing advanced cancer can be very challenging, and this research aims to find more effective ways to manage the disease.

The main purpose of this study is to see if AZD2265 works better than the treatments currently available. We will be looking at two key things: how long men live without their cancer growing or spreading further (this is called 'radiographic progression-free survival', which basically means the cancer isn't worsening on scans), and how long men live overall. This information will help doctors understand if AZD2265 offers a significant improvement over existing care.

About 670 men with this type of prostate cancer will join the study. They will be randomly assigned to receive either AZD2265 or one of the standard treatments chosen by their doctor. The study will continue until the cancer progresses, if side effects become too strong, or for other medical reasons. Throughout the study, participants will have regular scans to check on their cancer, and their health will be carefully watched by a team of experts.

Key takeaways

The VECTRA-01 study is testing a new drug, AZD2265, for advanced prostate cancer.
It aims to see if AZD2265 works better than standard treatments at controlling cancer growth and helping men live longer.
Around 670 men will participate, randomly receiving either AZD2265 or a standard treatment.
Participants will have regular scans and check-ups to monitor their health and the cancer.
This is for men whose prostate cancer has spread and is no longer responding to hormone therapy.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you must be an adult man, aged 18 or older, who has been diagnosed with prostate cancer that has spread and is no longer controlled by hormone therapy. You would also have already had certain treatments, such as a type of therapy called a PSMA-directed beta-emitting radioconjugate (at least two cycles) and a chemotherapy treatment containing 'taxane'. You also need to have positive PSMA PET/CT scans, which show specific features of your cancer.

There are also some criteria that would mean you couldn't join. For example, if you've already had a different type of radiation treatment called an alpha-emitting molecular targeted radioconjugate (though radium-223 is allowed). You also can't have certain other serious medical conditions or uncontrolled side effects from previous treatments. All participants must be able to manage daily activities reasonably well, and have healthy enough organs and bone marrow to take part.

Quick self-check

Are you an adult man (18 years or older) with prostate cancer that has spread?
Is your prostate cancer no longer responding to hormone therapy?
Have you previously had at least two cycles of a PSMA-directed beta-emitting radioconjugate?
Have you previously received a taxane-based chemotherapy treatment?
Have you previously had another type of hormone treatment (ARPI)?
Do you have positive PSMA PET/CT scans?

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

What does participation involve?

If you decide to take part in this study, you will first undergo screening tests to ensure you meet all the criteria. If you are eligible, you will be randomly assigned to receive either the new drug, AZD2265, or a standard treatment. This assignment is like flipping a coin – neither you nor your doctor can choose which treatment you get.

You will receive your assigned treatment until your cancer starts to grow, if you experience side effects that are too difficult to manage, or if your doctor decides it's best to stop for other reasons. Treatment involves regular visits to the clinic, which will include examinations, blood tests, and scans (like CT, MRI, and bone scans) to monitor your health and how your cancer is responding. Even after stopping the study treatment, you'll continue to have scans until your doctor confirms the cancer has progressed or if you pass away. We will also follow your overall health for the entire duration of the study.

Throughout the study, you will be asked to use contraception (condoms) and not to father children or donate sperm while on the study drug and for 6 months afterwards. This is a common safety measure in drug trials.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit of this study is that AZD2265 might be more effective than current treatments for your prostate cancer. You would also receive close medical attention and monitoring throughout the study. However, there is no guarantee that you will personally benefit from the treatment. All medications, including study drugs and standard treatments, can cause side effects, and some may be serious. The study team will explain all known potential side effects to you. It's important to remember that participating in this study is completely voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your future medical care.

Locations (90)

Research Site
Dothan, United States· Not yet recruiting
Research Site
Phoenix, United States· Not yet recruiting
Research Site
Irvine, United States· Not yet recruiting
Research Site
Loma Linda, United States· Not yet recruiting
Research Site
San Francisco, United States· Not yet recruiting
Research Site
Aurora, United States· Not yet recruiting
Research Site
Miami, United States· Recruiting
Research Site
O'Fallon, United States· Not yet recruiting
Research Site
Metairie, United States· Not yet recruiting
Research Site
Detroit, United States· Not yet recruiting
Research Site
Grand Rapids, United States· Not yet recruiting
Research Site
Omaha, United States· Recruiting

+78 more sites — see the official record for the full list.

Common questions

What is 'metastatic castration-resistant prostate cancer'?

This is prostate cancer that has spread beyond the prostate gland (metastatic) and is no longer controlled by treatments that lower testosterone levels (castration-resistant).

What is AZD2265?

AZD2265 is a new drug being tested in this study to see if it can help treat advanced prostate cancer more effectively than current options.

Will I definitely get the new drug AZD2265?

No, you will be randomly assigned to either receive AZD2265 or one of the standard treatments. This ensures a fair comparison.

How long will I be in the study?

You will receive treatment until your cancer progresses, you have unacceptable side effects, or your doctor decides you should stop. You will then continue to be followed up with scans and for your overall health until the end of the entire study.

What are PSMA PET/CT scans?

These are special scans that help doctors see prostate cancer cells in the body, as they show up in areas where there's a specific protein called PSMA on the cancer cell surface.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.