Full Title
A Phase 2/3, Randomized, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of FPI-2265 (225Ac-PSMA-I and T) in Patients with PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC), Previously Treated with 177Lu-PSMA Radioligand Therapy (RLT)Purpose
Prostate cancers initially need the male hormone testosterone for growth. Hormone therapies that lower the level of testosterone are among the best treatments for prostate cancers that have metastasized (spread). The benefits of hormone treatments do not last, however. Over time, many prostate cancers keep growing even with hormonal therapies. These are called castration-resistant prostate cancers (CRPC).
Researchers want to find the best dose of FPI-2265 to give to people with metastatic CRPC. The people in this study have prostate cancer cells with a protein called PSMA on them. PSMA is usually found on normal prostate cells, but is found in higher amounts on prostate cancer cells. In addition, the people in this study have prostate cancer that keeps growing after treatment with 177Lu-PSMA radioligand therapy (RLT).
FPI-2265 binds to PSMA. It uses a radioactive element to deliver radiation directly to cancer cells. These direct doses of radiation may destroy cancer cells. By targeting these cells, FPI-2265 may help slow or stop the growth of your cancer. FPI-2265 is given intravenously (by vein).
Who Can Join
To join this study, there are a few conditions. You must:
- Have metastatic CRPC that keeps growing after RLT.
- Have recovered from the serious side effects of prior anti-cancer therapies before getting FPI-2265.
- Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
- Be age 18 or older.
Contact
For more information or to see if you can join this study, please call Dr. Michael Morris’s office at 646-422-4469.