Active not recruitingPHASE3INTERVENTIONAL

Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment

This study is for men with advanced prostate cancer that has already spread and is no longer responding well to initial hormone treatments. It's investigating a new treatment called [Lu-177]-PNT2002. This treatment targets specific prostate cancer cells. The study aims to find out if [Lu-177]-PNT2002 is better than, or at least as good as, current hormone therapies (like abiraterone or enzalutamide) at stopping or slowing the cancer from growing further. Researchers will also be looking at how safe the new treatment is. If you've been diagnosed with this type of prostate cancer and your doctors are considering second-line treatment, this study might be an option to discuss with them.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company

Enrolment target

455

Start

25 Feb 2021

Estimated completion

01 Mar 2028

Metastatic Castration-Resistant Prostate Cancer

What is this study about?

This study is designed to explore a new way to treat prostate cancer that has spread to other parts of the body (called metastatic) and has become resistant to initial hormone therapy. This type of cancer is known as metastatic castration-resistant prostate cancer, or mCRPC. For many men, the cancer eventually stops responding to standard hormone treatments, so new options are important.

The new treatment being studied is called [Lu-177]-PNT2002. This drug works by targeting specific proteins on prostate cancer cells, aiming to deliver radiation directly to the cancer and destroy it. The study wants to see how well this new treatment works compared to two commonly used hormone therapies, abiraterone and enzalutamide, which are also used when the cancer becomes resistant to initial hormone treatment.

The main goal is to see if [Lu-177]-PNT2002 can delay the cancer from growing or spreading further, as seen on scans. They'll also be carefully checking for any side effects to make sure the treatment is safe. This research is important because it could offer another treatment choice for men with this advanced form of prostate cancer.

Key takeaways

Targets advanced prostate cancer that has spread and is resistant to standard hormone therapy.
Compares a new targeted radiation treatment ([Lu-177]-PNT2002) with existing hormone therapies.
Aims to see if the new treatment can slow cancer growth and is safe.
Requires a specific cancer marker (PSMA) to be present, checked by a special scan.
Involves regular check-ups and follow-up for several years after treatment.

Who may be eligible?

This study is looking for men aged 18 or older who have prostate cancer that has spread and is no longer responding to certain hormone treatments. Your cancer must be getting worse, which doctors will check through blood tests, scans, or both. You must also have decided with your doctor that chemotherapy isn't the right option for you at this time, or you can't have it.

An important part of qualifying is that your cancer cells must show a specific marker on a special type of scan called a PSMA-PET scan. This helps confirm that the new treatment can specifically target your cancer. Your testosterone levels must also be low, and your overall health, including how well your kidneys, liver, and blood are working, needs to meet certain standards.

Essentially, the study needs participants whose cancer has progressed despite previous hormone therapy, who have the specific PSMA marker, and who are otherwise healthy enough to take part in this type of treatment.

Quick self-check

Are you a man aged 18 or older?
Has your prostate cancer spread and is it no longer responding well to initial hormone treatments?
Are you unable or unwilling to have chemotherapy right now?
Have your doctors confirmed that your cancer has a specific marker called PSMA on a special scan?
Are your general health, blood counts, and organ functions (like liver and kidneys) reasonably good?

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

What does participation involve?

Taking part in this study involves several stages. First, a small group of about 25 patients will help researchers understand the best way to give the new treatment and check its immediate safety. After that, about 390 patients will be randomly assigned to one of two groups.

Two out of three patients will receive the new treatment, [Lu-177]-PNT2002. The remaining patients will receive either abiraterone or enzalutamide. If you are in the group receiving existing hormone therapies and your cancer starts to grow again, you might then be able to switch over and receive the new treatment. You will have regular appointments for check-ups, scans, and blood tests to monitor your health and how the treatment is working. After the main treatment phase, everyone will be closely followed for at least five years to observe the long-term effects of the treatment, including how long people live and their overall health.

Potential risks and benefits

Participating in a clinical trial might offer benefits like access to a new treatment before it's widely available, which could potentially slow down your cancer. However, there are also risks, as new treatments can have unexpected side effects, and the treatment might not work for everyone. You will have regular monitoring to help manage any side effects. It’s important to remember that you can decide to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (54)

Arizona Institute of Urology (AIU) - Tucson
Tucson, United States
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, United States
VA Greater Los Angeles Healthcare System
Los Angeles, United States
University of California Los Angeles, Nuclear Medicine Clinic
Los Angeles, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, United States
UC Irvine Chao Family Comprehensive Cancer Center
Orange, United States
Stanford Cancer Institute
Palo Alto, United States
University of Colorado Hospital
Aurora, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, United States
University of Iowa Hospitals and Clinics
Iowa City, United States
University of Kentucky Chandler Medical Center
Lexington, United States
Tulane University Medical Center
New Orleans, United States

+42 more sites — see the official record for the full list.

Common questions

What is 'castration-resistant' prostate cancer?

It means the prostate cancer is growing even when the amount of male hormones in your body is very low, usually due to previous hormone treatments.

What is [Lu-177]-PNT2002?

It's a new treatment being tested that uses a small amount of radiation delivered directly to prostate cancer cells that have a specific marker called PSMA.

Will I definitely get the new treatment if I join?

Not necessarily. In the main part of the study, you'll be randomly assigned to either receive the new treatment or existing standard treatments. However, if your cancer progresses on the standard treatment arm, you might be able to switch to the new treatment.

What does a 'PSMA-PET scan positive' mean?

It means a special scan showed that your cancer cells have a particular protein (PSMA) on their surface, which the new treatment is designed to target.

How long will I be involved in the study?

After your treatment, you will be followed up closely for at least five years to understand the long-term effects.