RecruitingPHASE1INTERVENTIONAL

A Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer: RADIOpharmaceutical DOSimetry Evaluation (RADIODOSE) Study

This study is for men with advanced prostate cancer that has spread and is no longer responding to standard hormone treatments. It's looking at a new treatment called AAA617. Researchers want to understand how much radiation dose the body receives, how safe the drug is, and what side effects it might cause when given for up to 12 cycles. This study is for patients who haven't had chemotherapy before for this type of prostate cancer and have specific changes on their cancer cells that AAA617 targets. The aim is to gather important information to help doctors best use this treatment in the future.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Novartis Pharmaceuticals

Enrolment target

106

Start

11 Nov 2024

Estimated completion

24 Nov 2028

Metastatic Castration-Resistant Prostate Cancer

What is this study about?

This study, called RADIODOSE, is looking into a new treatment called AAA617 for men with advanced prostate cancer. This is specifically for prostate cancer that has spread to other parts of the body (metastatic) and is no longer responding to standard hormone therapy (castration-resistant). It's also for men who haven't had chemotherapy for their advanced prostate cancer yet. The main goal is to understand how much of the treatment goes to different parts of the body (radiation dosimetry), how safe it is, and what side effects it might cause, especially when given for a longer period of up to 12 treatment cycles.

The treatment, AAA617, works by targeting specific areas on the prostate cancer cells called PSMA. This means it can deliver helpful radiation directly to the cancer cells. By studying this treatment further, doctors hope to learn how to use it most effectively and safely as a potential new option for men with this type of prostate cancer. Understanding the correct dosage and potential side effects over an extended period is crucial for its future use.

This study is a 'Phase 1' study, which means it's one of the first steps in testing a new treatment in humans. It focuses on safety and understanding how the drug works in the body. If the results are positive, it could pave the way for bigger studies to confirm its benefits for more patients.

Key takeaways

This study is testing a new treatment (AAA617) for advanced prostate cancer.
It's for men whose cancer has spread and no longer responds to hormone therapy, and who haven't had chemotherapy.
The treatment targets a specific marker (PSMA) on cancer cells.
The study will look at safety, side effects, and how the radiation treatment works in the body.
Participation involves regular treatments, scans, and follow-up over an extended period.

Who may be eligible?

This study is looking for men aged 18 or older with advanced prostate cancer that has spread and is no longer responding to hormone therapy. Your cancer must also have a specific marker called PSMA, which will be checked with a special scan. You should generally be feeling well enough to go about your daily activities with little difficulty.

There are also some important things that would mean you can't join the study. If you've had certain types of radiation treatments before, or chemotherapy for your advanced prostate cancer, you likely can't take part. You also shouldn't have had any recent serious heart problems. The study will also check your kidney function to make sure it's at a certain level.

Quick self-check

Are you an adult man aged 18 or older?
Do you have advanced prostate cancer that has spread and is resistant to hormone therapy?
Have you not received chemotherapy for your advanced prostate cancer?
Do you generally feel well enough to manage your daily activities?
Do you have a certain level of kidney function (checked by doctors)?
Have you *not* had any serious heart issues recently?

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

What does participation involve?

If you decide to join this study, it will involve several stages. First, there's a screening period where doctors will check if you're suitable for the study. This includes a special scan to confirm your cancer has the PSMA marker. If you qualify, you'll then enter the treatment period, which could last up to 74 weeks, with treatments given every 6 weeks. During this time, you'll receive the AAA617 drug directly into your vein. Doctors will regularly monitor you for side effects and how your body is reacting to the treatment. They will also do scans after a certain number of cycles to see if the treatment is still suitable for you.

After your treatment finishes, there will be a follow-up period. This involves further scans and check-ups to monitor your safety and how your cancer is doing over time. You can choose to stop participating in the study at any point.

Potential risks and benefits

Participating in a clinical trial like this could offer potential benefits, such as access to a new treatment that isn't widely available yet, which might help control your prostate cancer. However, as with any medical treatment, there are potential risks and side effects that your doctors will explain in detail. These can vary from mild to serious, and they will be carefully monitored throughout the study. Remember, taking part in a study is completely voluntary, and you have the right to withdraw at any time without affecting your usual medical care.

Locations (21)

University of California LA
Los Angeles, United States· Recruiting
Stanford University
Palo Alto, United States· Recruiting
Mayo Clinic Rochester
Rochester, United States· Recruiting
Wash U School of Medicine
St Louis, United States· Recruiting
Nebraska Cancer Specialists
Omaha, United States· Recruiting
Novartis Investigative Site
Cologne, Germany· Recruiting
Novartis Investigative Site
Wuppertal, Germany· Recruiting
Novartis Investigative Site
Aachen, Germany· Recruiting
Novartis Investigative Site
Berlin, Germany· Recruiting
Novartis Investigative Site
Essen, Germany· Recruiting
Novartis Investigative Site
München, Germany· Recruiting
Novartis Investigative Site
Rostock, Germany· Recruiting

+9 more sites — see the official record for the full list.

Common questions

What is AAA617?

AAA617 is a new treatment being studied for advanced prostate cancer. It's designed to deliver radiation directly to certain cancer cells.

What does 'PSMA-positive' mean?

PSMA is a special marker found on the surface of many prostate cancer cells. This treatment works by specially targeting cells with this marker.

Why is this study only for men who haven't had chemotherapy?

This study specifically wants to see how AAA617 works in men who haven't had chemotherapy for their advanced prostate cancer before, to understand its effects in this group.

How long will I be in the study?

The treatment part of the study could last up to 74 weeks, with treatments every 6 weeks. There's also follow-up monitoring after treatment ends.

Can I stop participating in the study if I want to?

Yes, you are free to leave the study at any time, for any reason, without affecting your current medical care.

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.