Active not recruitingPHASE1INTERVENTIONAL

[Ac-225]-PSMA-62 Trial in Oligometastatic Hormone Sensitive and Metastatic Castration Resistant Prostate Cancer

This research is investigating a new medication called [Ac-225]-PSMA-62 for different types of advanced prostate cancer. It's a 'Phase 1' study, which means the main goal is to find the safest and most tolerable dose of the treatment. Once that's determined, the study will look at how well the treatment works in men with prostate cancer that is either hormone-sensitive but has spread in a limited way (oligometastatic), or cancer that has spread widely and is no longer responding to standard hormone therapy (castration-resistant). The study involves multiple centres and is 'open-label', meaning both patients and doctors will know which treatment is being given.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Eli Lilly and Company

Enrolment target

142

Start

03 Apr 2024

Estimated completion

01 Dec 2032

Prostate Cancer Metastatic Castration-resistant Prostate Cancer Oligometastatic Prostate Carcinoma Hormone Sensitive Prostate Cancer

What is this study about?

This study, called ACCEL, is looking into a new treatment for prostate cancer. The treatment is a special type of medicine called [Ac-225]-PSMA-62. It's designed to target prostate cancer cells specifically.

The study has a few stages. First, it will find the safest dose of the treatment and see how well people tolerate it. This is really important when testing new medicines. After finding the right dose, the researchers will then look at two main groups of men with prostate cancer. One group has cancer that has spread a little (called 'oligometastatic') but is still responding to hormone treatments. The other group has cancer that has spread more widely and is no longer responding to standard hormone therapy (called 'castration-resistant'). The aim is to see how effective this new treatment is for these different situations.

The goal of this research is to potentially offer a new treatment option for men living with advanced prostate cancer. By understanding the safety and effectiveness of [Ac-225]-PSMA-62, doctors hope to improve care for patients in the future.

Key takeaways

This study is testing a new prostate cancer treatment called [Ac-225]-PSMA-62.
It aims to find the safest dose and see how well it works for advanced prostate cancer.
It's for men with prostate cancer that either has spread a little (oligometastatic) or is no longer responding to hormone therapy (castration-resistant).
Participation involves regular hospital visits, tests, and closely monitoring your health.
There's a chance for a new treatment, but also unknown risks and side effects.

Who may be eligible?

To join this study, you must have been diagnosed with prostate cancer confirmed by tests. You should generally feel well and be able to do your usual daily activities without too much difficulty.

If your prostate cancer has spread and is no longer responding to hormone therapy, you would typically have already received some other treatments, including a type of hormone treatment and possibly chemotherapy (unless you couldn't have it or chose not to). Your cancer also needs to be showing signs of getting worse, based on things like PSA levels, scans, or new spots on bone scans. Importantly, scans must show that your cancer has specific markers called PSMA.

If your prostate cancer is hormone-sensitive and has spread in only a few places, you would generally have had surgery or radiation therapy in the past. Your PSA levels would have gone up after these treatments, and scans would show 1 to 5 spots where the cancer has returned outside the prostate area.

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.

Do I have prostate cancer confirmed by a doctor?
Do I generally feel well enough to do my daily activities?
If my cancer has spread and isn't responding to hormone therapy, have I had certain past treatments like specific hormone drugs and possibly chemotherapy?
Do my scans show that my cancer has 'PSMA' markers?
If my cancer is hormone-sensitive and has spread in only a few places, has my PSA gone up after previous treatments like surgery or radiation?
Are there 1 to 5 spots of cancer outside my prostate on my scans?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the hospital for checks and to receive the study treatment, [Ac-225]-PSMA-62. Doctors would closely monitor your health and how you're feeling. You would have blood tests, scans, and other medical examinations to see how the treatment is affecting you and your cancer. This monitoring would continue for a period after your treatment is finished. The exact number of visits and the full length of your participation would be explained in detail by the study team, but clinical trials typically involve several months to a year or more of active involvement, followed by longer-term follow-up.

Potential risks and benefits

Participating in a study like this might offer a chance to try a new treatment that isn’t widely available yet, which could potentially help your condition. However, new treatments can have side effects that are not fully known, and there is no guarantee that it will work for you. The study team will carefully monitor you for any side effects, and you will be informed of any known risks before you decide to join. Remember, taking part is completely voluntary, and you are free to withdraw from the study at any time without affecting your medical care.

Locations (7)

Juravinski
Verified postcode
Hamilton, Canada
Jewish General Hospital
Verified postcode
Montreal, Canada
McGill University
Verified postcode
Montreal, Canada
Centre Hospitalier Universite de QUEBEC
Verified postcode
Québec, Canada
Hopital De Chicoutimi
Verified postcode
Saguenay, Canada
Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada
BC Cancer Vancouver
Verified postcode
Vancouver, Canada

Common questions

What is PSMA?

PSMA stands for Prostate-Specific Membrane Antigen. It's a protein often found on the surface of prostate cancer cells, which the new treatment in this study is designed to target.

What does 'hormone-sensitive' prostate cancer mean?

This means your prostate cancer is still responding to treatments that lower male hormones (like testosterone), which can help slow its growth.

What does 'castration-resistant' prostate cancer mean?

This refers to prostate cancer that has progressed even when your testosterone levels are very low due to hormone therapy. It means the cancer is no longer controlled by standard hormone treatments.

What is 'oligometastatic' prostate cancer?

This is when prostate cancer has spread to a limited number of spots (usually 1-5 areas) outside of the prostate gland itself.

What does 'Phase 1 study' mean?

A Phase 1 study is usually the first time a new drug is tested in people. Its main goal is to find a safe dose and understand how the drug behaves in the body, rather than focusing on how well it treats the disease yet.