Active not recruitingPHASE2INTERVENTIONAL

A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC

This clinical trial is investigating a new treatment called AAA617 for men with prostate cancer. Specifically, it's for a type of prostate cancer that has become resistant to standard hormone treatment (castration-resistant prostate cancer) and shows up positively on a special PSMA PET scan, but hasn't spread elsewhere in the body according to regular scans. The study will test AAA617 by itself and also AAA617 combined with another type of hormone-blocking drug (ARPI). The main goals are to see how well these treatments work and if they are safe. This is a Phase 2 study, meaning researchers are still gathering information about effectiveness and side effects in a larger group of people.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Novartis Pharmaceuticals

Enrolment target

Start

03 Jan 2024

Estimated completion

23 Dec 2026

Prostatic Neoplasm

What is this study about?

This study is looking into a new treatment for men with a specific type of prostate cancer. Prostate cancer often relies on male hormones to grow. When standard hormone therapy stops working, it's called 'castration-resistant prostate cancer' (CRPC).

Doctors want to find better ways to treat CRPC. This study focuses on a new drug called AAA617. Before joining, participants will have a special scan called a PSMA PET scan. This scan helps doctors see if the cancer cells have a particular target on their surface (called PSMA) that AAA617 can attach to. It also confirms that, while the cancer is resistant to hormone treatment, it hasn't spread to distant parts of the body according to other standard scans like CT, MRI, and bone scans.

The study will test AAA617 in two ways: some men will receive AAA617 on its own, and others will receive AAA617 alongside another type of hormone-blocking drug (called an ARPI). The main goal is to find out if these treatments are effective at controlling the cancer and if they are safe to use. This research is important because it could lead to new treatment options for men whose prostate cancer is no longer responding to initial hormone therapy.

Key takeaways

This study investigates a new treatment (AAA617) for advanced prostate cancer.
It's for prostate cancer no longer responding to standard hormone therapy, but not yet spread widely.
A special PSMA PET scan is needed to check if the treatment is suitable for you.
Both AAA617 alone and combined with other hormone-blocking drugs are being tested.
The study aims to understand how effective and safe this new treatment is.
Participation could last around three years, with regular check-ups.

Who may be eligible?

To join this study, you must be an adult male, at least 18 years old, and have prostate cancer confirmed by a doctor. Your prostate cancer must be of the 'castration-resistant' type, meaning it's no longer fully controlled by initial hormone treatment, and your hormone levels need to be at a specific low level because of ongoing hormone therapy or a previous surgery.

Crucially, a special PSMA PET scan must show that your cancer cells have a particular marker (PSMA), which the new treatment targets. However, other common scans like CT, MRI, and bone scans must show that your cancer has not spread beyond the prostate area. You also need to be in generally good health, with your organs (like your kidneys and liver) working well.

You cannot join if you have signs of cancer spread on regular scans, or if you have certain heart problems, a history of seizures, or unmanageable bladder problems. If you've had certain previous treatments, you might also not be able to participate. The study team will review all your medical information carefully to see if you are a good fit.

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 (18 years or older)?
Have you been diagnosed with prostate cancer that is no longer responding well to hormone therapy?
Are you currently on ongoing hormone therapy or have you had a specific surgery?
Do you have a PSMA-positive scan but no signs of distant cancer spread on regular scans?
Do you have generally good overall health, including normal function of your organs?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll first have some scans, including a special PSMA PET/CT scan, and other tests to make sure you're eligible. The main treatment part involves receiving the study drug (AAA617) up to six times, with each treatment given every six weeks. Some participants might also continue taking another hormone-blocking drug if they were already on one.

You will have regular check-ups during the treatment period, typically every week 1 and week 4 of each 6-week cycle. After the six treatment cycles, you'll continue to have follow-up visits every 16 weeks to monitor your health and the cancer. Some of these visits might be done remotely, depending on the schedule.

The total participation in the study, including treatment and follow-up, is expected to last about 36 months (3 years) until the study ends or if your cancer progresses.

Potential risks and benefits

Participating in research studies like this can offer the potential benefit of accessing new treatments before they are widely available. However, there are no guarantees that the treatment will work for you, and there may be side effects, some of which are not yet fully known. All medical procedures and drugs carry potential risks, and the study team will carefully monitor your health and any side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (37)

Rocky Mountain Cancer Centers
Verified postcode
Denver, United States
University Cancer and Blood Center LLC
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Athens, United States
Urology Of Indiana
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Indianapolis, United States
Unity Point Clinic
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Des Moines, United States
Urology Cancer Center PC
Verified postcode
Omaha, United States
Associated Med Professionals of NY
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Syracuse, United States
Oregon Urology Institute
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Springfield, United States
Wellspan York Hospital
Verified postcode
York, United States
Coastal Cancer Center
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Conway, United States
Carolina Urologic Research Center
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Myrtle Beach, United States
Carolina Regional Cancer Center
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Myrtle Beach, United States
Univ of Texas Southwest Med Center
Verified postcode
Dallas, United States

Common questions

What is 'castration-resistant prostate cancer'?

This means your prostate cancer has stopped responding to traditional hormone therapy, even though your body's testosterone levels are very low.

What is a PSMA PET scan?

It's a special imaging test that helps doctors find prostate cancer cells by looking for a marker called PSMA on their surface.

What does 'Phase 2 study' mean?

It means the study is in a stage where researchers are looking more closely at how effective the new treatment is and its safety in a larger group of people, after earlier safety tests.

Will I automatically get the new drug?

Participants will be assigned to different groups, so some will get AAA617 alone, and others will get it combined with another drug. Details will be explained by the study team.

How long will I be involved in the study?

If you participate, the study could last for about 3 years, including treatment and regular follow-up appointments.