A MULTICENTER PHASE 3, OPEN-LABEL, RANDOMIZED, CROSSOVER STUDY

A study for men with metastatic castration-resistant prostate cancer

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Taking the next step in your treatment sometimes
means taking part in a clincal study.

The SPLASH Study is for men with prostate cancer that has spread beyond the prostate and progressed after hormone therapy. Your doctor can determine whether you are eligible to take part.

About Clincal Trials

Clinical trials are research studies used to find out whether new treatments are safe and effective, and work better than current treatments. Clinical trials are strictly monitored and carefully evaluated.

Before deciding whether to take part in a clinical trial, you will be provided detailed written information about the study in an Informed Consent Form, which you’ll have time to read and review. Once you understand and agree to be in the study, you will be required to sign the informed consent form. When you take part in a clinical trial, you add to our knowledge about prostate cancer and help improve care for future patients.

About the SPLASH study

Why is the SPLASH study important?

Metastatic castration-resistant prostate cancer (mCRPC), is prostate cancer that has metastasized, or spread to other areas of the body, and that has progressed after hormone therapy. When metastatic prostate cancer does not respond to treatments such as surgery, radiation, and hormone therapy, there are very few treatment options.

The SPLASH study is testing an investigational therapy (called 177Lu-PNT2002) against the current standard treatment (either abiraterone or enzalutamide) to see whether 177Lu-PNT2002 is safe and effective when prostate cancer reaches this point.

Biopharmaceutical companies use clinical research studies like this one to learn more about investigational therapies before they are made available to the public. Your participation in this study, if you are eligible, can help improve the understanding of this therapy, potentially helping make it available to others in the future.

What will happen in the SPLASH study?

everyone receives treatment

During the study, all participants will be treated with either 177Lu-PNT2002 or with the current standard of care therapy. Everyone receives active treatment in this study. There is no placebo(inactive treatment).

2 parts to the study:
  1. The first 25 patients will receive 4 doses of 177Lu-PNT2002,spread out over 32 weeks (7 months).
  2. The next 400 patients will be randomized to either receive 177Lu-PNT2002 or one of two existing approved therapies, abiraterone or enzalutamide, over 32 weeks (7 months).

    Participants who are receiving standard of care and experience progression of their disease (confirmed by radiologic testing) may be eligible to switch therapies to 177Lu-PNT2002.

Participants from both parts of the study will receive long-term follow up for up to 5 years.

Staying in the study throughout all parts (including long-term follow up) is important and will help researchers better understand the therapy.

177Lu-PNT2002 is an investigational therapy. Investigational therapies have not yet been approved by the U.S. Food and Drug Administration(FDA) or any other regulatory agency.

What treatment is being studied in SPLASH?

The study therapy is called 177Lu-PNT2002. It is known as a type of radioligand therapy.

What is radioligand therapy?

Radioligand therapy is an innovative approach to treating certain types of cancer, including prostate cancer. It works by delivering a precise dose of radiation directly to specific cancer cells, with a minimal effect on healthy cells.

Where to Go for More Information

Your doctor will determine whether you are eligible to participate in the SPLASH study. He or she can also answer questions you may have about the study or your prostate cancer and treatment options.

Ask Your Doctor or Care Team about SPLASH

Question You May Have

What tests will I need?

One of the primary goals of the SPLASH study is to see whether 177Lu-PNT2002 prevents the progression of prostate cancer.

At the beginning of the study, you will have a CT (computerized tomography) scan. This scan usually takes from 10 to 30 minutes and will allow the researchers to get a baseline image so that your disease can be evaluated over the course of the study.

Before you receive the study treatment, you will undergo an imaging biomarker (PET) scan that will be used to determine if your cancer has markers that the treatment would target. Other tests will be needed and you can discuss these with a study team member.

To help determine whether your disease progresses during the study, you will need to receive regular radiologic scans.

Which Treatment Will You Receive?

The process of deciding who goes on which treatment is called randomization, which is like the flip of a coin. In the SPLASH Study, for every 1 patient randomized to receive standard treatment, 2 will receive the study treatment. This means you have a greater chance of receiving the study treatment than the standard.

In the SPLASH Study, there is no placebo, so everyone receives active treatment(either study treatment or standard treatment).

If your disease worsens (confirmed by radiologic scans) while you are on standard treatment, you may be eligible to cross over to receive the study treatment.

What are the costs to Take part in SPLASH?

Study participants will not be charged for the tests and procedures that are needed for the study.

You may be eligible for reimbursement of your travel expenses to and from the study clinic. Your study doctor or nurse can provide additional details regarding travel reimbursement.

How long will the SPLASH study last?

Your total participation time in the SPLASH study is expected to be under 6 years. This includes includes the 30-day screening period, the 32-week treatment period, and the 5-year follow up period.

Sticking with the study throughout the entire duration will be important to helping researchers gain the best understanding of the study drug.

To Find out More or participate in this trial, Ask Your Doctor or Care Team for more information about the SPLASH Trial (NCT04647526)