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.
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.
Ensuring Access to 177Lu-PNT2002
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.
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. 177Lu-PNT2002 is also known as 177Lu-PSMA-I&T in previous studies.
The study therapy is called 177Lu‑PNT2002. It is known as a type of 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.
Your doctor will determine whether the SPLASH study may be right for you. He or she can also answer questions you may have about the study or your prostate cancer and treatment options.
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.
As part of your Screening procedures, you will be asked to undergo PET/CT imaging with 18F-DCFPyL or 68Ga-PSMA-11 (“PSMA PET scan”). These are investigational imaging agents used to help visualize your prostate cancer by also targeting PSMA, the same protein targeted by 177Lu-PNT2002 therapy. If your disease does not express high PSMA levels based on the PSMA PET scan, you will not be able to continue in the study.
To help determine whether your disease progresses during the study, you will need to receive regular radiologic scans.
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.
Your total participation time in the SPLASH study is expected to be under 6 years.
Sticking with the study throughout the entire duration will be important to helping researchers gain the best understanding of the study drug.