RecruitingPHASE3INTERVENTIONAL

Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC

This study focuses on men with a type of advanced prostate cancer that has spread and is no longer responding to standard hormone therapy. Researchers want to see if a new treatment called AAA817, when given with other prostate cancer medications (ARPIs), can slow down the cancer's growth more effectively than current standard treatments. These standard treatments could be a different ARPI, chemotherapy, or another type of targeted radiation therapy. Participants will either receive the new combination or one of the standard care options. The main goal is to find out if the new treatment keeps the cancer from getting worse for longer periods.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Novartis Pharmaceuticals

Enrolment target

940

Start

01 Jul 2025

Estimated completion

04 Nov 2032

Prostate Cancer

What is this study about?

This study is looking into a new way to treat prostate cancer that has spread to other parts of the body and is no longer responding to initial hormone treatments. This type of cancer is called metastatic castration-resistant prostate cancer, or mCRPC for short. Scientists are particularly interested in men whose cancer cells show a specific marker called PSMA.

The main idea of the study is to compare a new treatment combination, which includes a drug called AAA817 along with a type of medication known as an ARPI (androgen receptor pathway inhibitor), against treatments that are currently available. These current treatments could be switching to a different ARPI, having chemotherapy, or receiving another targeted radiation treatment called AAA617. Researchers want to see if the new combination can delay the cancer from growing or spreading further for a longer time compared to standard options. The study is in its third phase, which means it's a large study aiming to confirm if the new treatment is better.

Taking part in this study means you would be randomly assigned to either receive the new AAA817 combination or one of the standard treatments. Doctors will carefully monitor your health and how your cancer responds throughout the study. The aim is to find better ways to manage advanced prostate cancer and improve patients' lives, so new research like this is really important.

Key takeaways

This study evaluates a potential new treatment (AAA817+ARPI) for advanced prostate cancer.
It's for men whose prostate cancer has spread, is resistant to hormone therapy, and shows a PSMA marker.
The new combination is compared to standard care options like different hormone drugs, chemotherapy, or another type of targeted radiation.
The main goal is to see if the new treatment can keep the cancer from growing for a longer time.
Participants will be randomly assigned to receive either the new treatment or a standard treatment.
Close medical monitoring and supportive care will be provided for all participants.

Who may be eligible?

This study is specifically for adult men, aged 18 or older, who have prostate cancer that has spread and is no longer responding to standard hormone therapy. Your prostate cancer cells must also light up on a special scan called a PSMA-PET scan. You should generally be feeling well enough to participate in daily activities without too much difficulty.

To be considered, you must have been treated with a type of drug called an ARPI in the past, and your cancer must have started progressing while on that treatment. However, you should not have received chemotherapy for your spread-out prostate cancer, though it's okay if you had chemotherapy for earlier, less advanced prostate cancer. You also can't have had any similar radiation treatments before this study.

There are certain reasons you wouldn't be able to join. For example, if you've had previous radiation treatments that target PSMA, or other specific radiation treatments. Also, if you've had certain types of chemotherapy recently for your advanced prostate cancer, or if your cancer has a rare mixed type, you likely wouldn't be eligible.

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 an adult male aged 18 or older?
Do you have prostate cancer that has spread and is no longer responding to standard hormone therapy?
Has your doctor confirmed your cancer shows the PSMA marker on a special scan?
Have you been previously treated with an ARPI drug, and did your cancer start growing again while on it?
Have you NOT received chemotherapy for your spread-out prostate cancer (it's okay if you had it for earlier prostate cancer)?
Have you NOT had any similar type of radiation treatment for your prostate cancer previously?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll first have a screening period. This involves several checks to make sure the study is right for you, including blood tests and a special scan (PET/CT) to check for the PSMA marker on your cancer. If you qualify, you will be randomly assigned to one of the treatment groups – either the new AAA817 and ARPI combination or one of the standard treatments.

The AAA817 treatment would be given as an injection into your vein, up to 6 times over a period. ARPI medications are taken as pills. The standard treatments could involve different ARPI pills, chemotherapy injections, or another radiation treatment (AAA617) given into your vein. Doctors will decide the best standard treatment for you, following usual guidelines. Regardless of which group you're in, you'll have regular hospital visits for check-ups, scans, and blood tests to monitor your health and how your cancer is responding. The exact number of visits and tests will be explained fully by the study team. Supportive care to help manage symptoms will be allowed for all participants.

Potential risks and benefits

Taking part in a clinical trial may offer certain benefits, such as access to a new treatment that isn't widely available yet, or close monitoring by a specialist medical team. However, there are also potential risks, including side effects from the study drugs or treatments. These will be fully explained to you before you decide to join. It's important to remember that new treatments might not always work better than existing ones, and sometimes they might not work at all for some people. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (55)

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

Sansum Clinic
Verified postcode
Santa Barbara, United States· Recruiting
Rocky Mountain Cancer Centers
Verified postcode
Denver, United States· Recruiting
Miami Cancer Institute at Bapt
Verified postcode
Miami, United States· Recruiting
AdventHealth
Verified postcode
Orlando, United States· Recruiting
Univ Of Iowa Hospitals And Clinics
Verified postcode
Iowa City, United States· Recruiting
University of Kansas Hospital
Verified postcode
Kansas City, United States· Recruiting
Wash U School of Medicine
Verified postcode
St Louis, United States· Recruiting
Bassett Medical Center
Verified postcode
Cooperstown, United States· Recruiting
Weill Cornell Medicine NY-Presb
Verified postcode
New York, United States· Recruiting
University of Rochester Medical Ctr
Verified postcode
Rochester, United States· Recruiting
Associated Med Professionals of NY
Verified postcode
Syracuse, United States· Recruiting
Carolina Urologic Research Center
Verified postcode
Myrtle Beach, United States· Recruiting

Common questions

What is PSMA and why is it important for this study?

PSMA is like a specific sign on the surface of some prostate cancer cells. This study only includes men whose cancer cells have this PSMA sign, as the new treatment AAA817 specifically targets these cells.

What is an ARPI?

ARPI stands for androgen receptor pathway inhibitor. These are medications that help block the effects of male hormones, which can fuel prostate cancer growth, helping to slow down the cancer.

What does 'randomised study' mean?

A randomised study means that participants are put into treatment groups by chance, like flipping a coin. This helps make sure the groups are similar, so researchers can fairly compare the treatments.

Will I know which treatment I am receiving?

Yes, this is an 'open label' study, which means both you and your study doctor will know which specific treatment you are receiving.

How long will I be in the study?

The study lasts as long as your treatment continues and then involves follow-up to track your health. The exact length will depend on how your cancer responds, but the treatment itself could be up to 6 cycles for AAA817.

How to find out more

Novartis Pharmaceuticals

novartis.email@novartis.com 1-888-669-6682 Official trial record

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